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					Source: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php
MEDICAL DEVICES RECALL LISTINGS : August 30, 2010
                                 Trade Name
A) BD Q-Syte Extension SetB) MPS Acadia Extension Set With RightboreC) MPS Acadia Specialty Tri-Extension Set      D) D
A) Vitek 2 Compact 30 System - Test CardsB) Vitek 2 Compact 60 System - Test CardsC) Vitek 2 System - Test Cards
TD-Synergy
A) TDLimsB) TD-Synergy
Elecsys Vitamin D3 assay
Sex Hormone Binding Globulin (SHBG) Reagent
Synchron System(s) Creatine Reagent
Pleatman Sac Tissue Removal System
Scorpio T72 Insert Tibial Trials
Osteonics Series 7000 Total Knee Standard Tibial Tray
A) Cell-Dyn 4000 Vent Needle and Accessory KitB) Cell-Dyn Sapphire Vent Head Assembly and Accessory Kit
IN2IT - A1C Test Cartridges
Anesthetic Gas Monitor Water Trap
Instructions for use (IFU) for Painpump2 Block-Aid
A) Sterile Craniotomy PackB) Sterile Ear Pack
Elecsys Free T4
A) Coaguchek XS MonitorB) Coaguchek XS Plus Monitor
Heartstart MRX Defibrillator / Monitor
Vitros Chemistry Products MALB Reagent
COBE Spectra White Blood Cell SetsUpdated recall # 55784 previously posted 2010-08-02. / Mise à jour du retrait # 557
Excyte Sliders
A) ADVIA Centaur Hepatitis B Core Total (HBCT) AssayB) ADVIA Centaur XP System-HBC Total (HBCT) assay (donor screeni
IGFBP-3 Immunoradiometric Assay (IRMA)
Gemstar Pump Set (110 Yellow)(AMB.INFU)
Liason Analyzer
Dytonics Bonecutter Electroblade
i-Stat Level 2 Control Value Assignment Sheet (VAS)
Dermal Roller SR
Acuvue Oasys Brand Contact Lenses for Astigmatism
A) Tina-Quant D-Dimer Gen.2 for Cobas Integra and Cobas C-SystemB) Tina-Quant D-Dimer Gen.2 for Roche/Hitachi 917 and
Precicontrol Universal
A) Sterling Monorail PTA BalloonB) Sterling Over-The-Wire PTA Balloon
A) Mevatron Linear AcceleratorsB) Artiste MV-Linear Accelerator-Main Unit
Synchron Systems Glucose Reagent (GLU)
CS300 Intra-Aortic Balloon Pump
Immage Immunochemistry Systems Buffer 1(BUF 1)
Focal Software
XIO Radiation Treatment Planning System
A) Calcium Sulfate Hemihydrate Kit, 1gB) Calcium Sulfate Hemihydrate Kit, 0.5g
Disposable Surgical Extension Cable
i-Stat PT/INR Cartridges
A) Altrua 20 Implantable Pulse GeneratorB) Altrua 40 Implantable Pulse GeneratorC) Altrua 50 Implantable Pulse GeneratorD)
PD Access 18 Gauge Vascular Access Device
A) Vaxcel Port/Mini/T/PU/6F/1.1/1.9B) Vaxcel Port w PASV/Mini/T/PU/6F/1.1/1.9C) Vaxcel Port w PASV/Standard/T/PU/8F/1.6/
Futurabond NR Single Dose
Flexible Probe with Blocking Washer (part of the Segmented Cylinder Set)
A) Immulite 2000 System-Chemiluminescent SubstrateB) Immulite 2000 System-Chemiluminescent Substrate ModuleC) Immul
Sterile Disposable Syringe Kit
Genesis II Resection Cutting Blocks
Hemochron Signature Elite Instrument
A) Heartstart FRX AEDB) Heartstart HS1 Onsite Defibrillator
A) Staclot LA 20B) Start 4 IVD Coagulation Analyzer
Architect Sirolimus Reagent
Ortho Provue Analyzer Software V. 3.1
Ortho Provue Analyzer Software V. 3.1
Flexima Biliary Stent System
Medrad Stellant CT Dual Syringe Kits
Aplio XG Ultrasound System - Main
Surgical Trocars - Separator
A) Allura XPER FD10/10 - Main UnitB) Allura XPER FD20/10 System - Main UnitC) Integris H5000C Catdiology Imaging SystemD
Internal Defibrillation Paddles
A) Coulter PrepplusB) Coulter Prepplus 2
A) Spot LX1 With BP & TemperatureB) Spot LXI With NIBP, Temperature & SPO2
A) Unicel DXI600 Access.Imm.Sys.-ACCU TNIB) Access Immunoassay System-ACCU TNIC) Unicel DXI800 Acc.Immuno.Sys.-ACCU
A) Elecsys Free PSA Reagent CapsB) Elecsys CEA Reagent CapC) Elecsys CA 15-3 Reagent CapD) Elecsys CA 125 II Reage
A) Elecsys CK-MB Reagent CapB) Elecsys Vitamin D3 reagent CapC) Elecsys pro BNP reagent CapD) Elecsys TG Gen.2 Reag
A) Stellaris Vision Enhancement W/AVSB) Stellaris Vision Enhancement W/AFSC) Stellaris Vision Enhancement W/AFS, HSVD
A) Axiom Iconos R200 C20-CB) Axiom Iconos R200 C90-CC) Axiom Iconos R200 T90_AD) Axiom Iconos R200 T90_B
A) Access System - Cortisol AssayB) Access System - Progesterone AssayC) Unicel DXI600 Acc.Immuno.Sys.-CortisolD) Unic
A) APO CAL (Apolipoprotein Calibrator)B) Synchron Systems APO-B Reagent
hm550OVP Cryostat
Amsco 3085SP Surgical Table
Steris 9" Urology Extension
Versacell
Clear-Guard II Breathing Filter
A) Quantanase Neonatal Phenylalanine Screening KitB) Quantanase Neonatal Elution Buffer
A) OneTouch SureStep Test Strips (100s)B)    SureStepPro Test Strips (50s)
Cobas AmpliPrep Reagent Tip
A High RES SSP Unitray
Evacuated Containers
A) Trusat OximeterB) Trusat Oximeter - With Expension Option
Dimension Vista System
TempSpan Temporary Crown and Bridge Material
A) Bath Safe Adjustable Shower Seat w/o Back and ArmsB) Bath Safe Adjustable Shower Seat with BackC) Bath Safe Shower Se
Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner
DRB1*04 SSP Unitray
Implant Extraction Set
Dyonics 25 Fluid Management System-Patient Tube Set
A) Mevaton Primus AccessoriesB) Mevatron Linear Accelerators
Acuson Antares
Sequenser for MOSAIQ Upgrade
Eosin Stain SS035C
A) Moeller Arginine + AgarB) Moeller lysine + AgarC) Moeller Arginine + BrothD) Moeller Decarb. ControlE) Moeller Lysine Dec
Entake Tri-Funnel G-Tube
A) Acuson Antares System-Main UnitB) Acuson Antares System-Refurbished UnitC) Acuson Antares System-With 5.0 Upgrades
Galileo Echo Blood Bank Analyzer
Express 4 Statspin Centrifuge
Architect HAVAB-IGM Reagent
A High RES SSP Unitray
A) ABC SSP Unitray and B Locus SSP UnitrayB) AB/DR SSP Unitray
Internal Indirect Transfer Copings
Tomotherapy Hi-Art System
Amsco Harmony Surgical Lighting and Media System
A) Nexus 1B) Nexus 2Updated recall # 52535 previously posted on 2010-02-01
Nexus 3Updated recall # 52174 previously posted on 2010-02-01
Ultrathin Diamond Balloon D. Catheter
Brain Heart Infusion Broth
A) Depuy ASR Acetabular Cup System - HeadsB) ASR XL Acetabular Cup System - HeadsC) ASR XL Acetabular Cup - Sleeve Adap
3M Micropore Surgical Tape
Quantiferon-TB Gold In-Tube
Ilumavision Software Ver. 2.1.0
Heater Wire Adaptors
A) AW VolumeshareB) AW Volumeshare2
Streamlab Analytical Workcell
Uric Acid Assay
A) Calcar Planer Surgical ProtocolsB) Accolade Surgical Protocol
Acuson S2000
A) Renegade Fiber Braided MicrocatheterB) Renegade Hi-Flow Microtainer
Renegade Fiber Braided Microcatheter
Histopaque 1077-1
A) Transport StretcherB) M-Series StretcherC) Trauma StretcherD) Eye Surgery Stretcher
Express SD Premounted Stent System
Steris Harmony LL500/700 Surgical Light
GT Obturators
Hypergel 5 Gram
Speedlink 5.5 Transverse Connector
A) Definium 8000 Digital Radiographic SystemB) Proteus XR/A General Purpose RadiographicC) Revolution XR/D Digital Radio
Synex II System - Central Body
A) Immulite System-Reactive Protein (CRP) AssayB) Immulite 2500 System-HIH Sensit CRP AssayC) Immulite 1000 System-Card
Revolution Centrifugal Blood Pump
Da Vinci S Surgical System, Model IS2000
Sarns Disposable Centrifugal Pump
Giraffe & Panda T-Piece Resuscitation System
Connection Bracket 1180.36AO
MC5057 Universal CableUpdated recall # 50401 previously posted on 2009-09-14.
A) PowerProMax Battery Modular HandpieceB) PowerProMax Battery 2-Trigger/Full F HPC) PowerProMax Oscilator Ha
Impression Coping Closed Tray
XTEN, HLX 3004, HLX 3005
A) Antistreptolysin O AssayB) Antistrepolysin O AssayC) IGM Flex AssayD) ASL Flex Reagent
Sarns Disposable Centrifugal Pump
Engen Automated Sample Handling System
AdvanSync Orthodontic Device
Dimension Vista System-Urea Nitrogen Assay
Lexicon K-File
Neptune 2 Ultra Rover
Amplatz PTFE-Coated Guidewire
Endoclamp Aortic Catheter
Revlite
Equalizer Balloon Catheter
Manual Pulmonary Resuscitator (MPR)
Bryan Cervical Disk System
A) Screwplant ImplantsB) Screwplant Healing CollarsC) Legacy Healing CollarsD) Screwindirect ImplantsE) Screwplus
Contour SE Microspheres
Maquet Hanaulux Model Blue 130
Guider Softip Guiding Catheter
Syngo Imaging XS
Syngo Imaging XS
Heater Wire AdaptorsUpdated recall # 50850 previously posted on 2009-10-12.
Midas Touch Needle Electrode
Wallach LL 100 Cryosurgery Device
Von Willebrand Reagent
XIO Radiation Treatment Planning System
A) Acuson Antares Software Version 4.0B) Acuson Antares Main Unit/5.0 Upgrades
Goldmann Applanation Tonometer Prism
Gammacoat Plasma Renin Activity 123I RIA Kit
Syngo Dynamics C.S.A.N.-5.X,6.X,7.0
A) Voluson E8 Ultrasound System Main UnitB) Voluson E8 Expert Ultrasound System
Intertan Hex Screw
A) Artiste Syngo RT Therapist AssistB) Artiste Syngo RT Therapist
IW900 Series Infant Warmer
070 Neuron Delivery Catheter
BCI 9015 4-Channel Analog Output Cable
Endo Femoral Aimers
A) TCD Drainage CathetersB) SKATER Single Step Drainage Set
A) Triporteur Star 3B) Quadriporteur Star 4
TheraScreen K-Ras Mutation Kit
A) Online TDM Gentamicin for Roche/HitachiB) Online TDM Gentamicin (GENT2) for Cobas
pRK(Rabbit Kidney)
Gynecare Morcellex Tissue Morcellator
IW900 Series Infant Warmer
Systeme PhD EIA/IFA (cat# 426-0246)
Insight Software Revision H,Bioview REV5.5.1
A Locus High Resolution SSP Unitray
Recon Plate 8 X 9mm, 3.5mm
Periarticular Locking Plate System
A) PDS II Absorbable SuturesB) Coated Vicryl Absorbable Sutures
ASP Automatic Endoscope Reprocessor
Apexpro Telemetry System - Clinical Info.
Heartmate XVE And II LVAS Battery Clip
Reflex Hybrid Screw Extractor Inner Shaft
Trinest Microplate Incubator And Shaker
Bard Magnum Core Tissue Biopsy Needle
Innova 2121IQ Bi-Plane Cardio Imaging
Titan Anchor Accessory Kits
Steinmann Pin
Therascreen K-Ras Mutation Kit
A-Dec Decade Plus 1221 Dental Chair
Complement Control Cells
Synex II System - Central Body Updated recall # 50981 previously posted on 2009-10-12.
Advantage, 2-Button Turbo Handpiece
Advent 4.5mmd Platform Tapered Abutment
Remstar M Series Heated Humidifier
Centricity PACS Workstation - Software
CyberKnife Robotic Radiosurgery SystemUpdated recall # 50252 previously posted on 2009-08-31.
Colleague Volumetric Infusion PumpsUpdated recall # 44735 previously posted on 2008-11-24.
Leksell Stereotactic System - Fixation Post
A) Nexgen Rotating Hinge Knee - FemoralB) Nexgen Rotating Hinge Knee - TibialC) Nexgen Rotating Hinge Knee,Tibial Plate
RET-Search II
Durom Acetabular Cup
A) Therakair VisioB) InfoV.A.C. Therapy UnitC) First Step All in OneD) ActiV.A.C. Therapy UnitE) First Step Select - PumpF) Kin
Staphytect Plus/Dryspot, Test Kits
A) Accura Breast Localisation NeedlesB) Hawkins II Breast Localisation NeedlesC) Hawkins I Breast Localization NeedlesD) Ho
neoBLUE mini LED Phototherapy System
A) Unicel DXI600 Access Immunoassay System Class 2 B) Unicel DXI600 Access Immunoassay System Class 3C) Unicel DXC
Dupaque X-Ray Detectable Sponges
A) Artiste MV-Syngo RT Therapist AssistB) Artiste MV-Syngo RT Therapist
Medical Grade Flat Panel Display
Vertical Surgical Table
Medfusion Syringe Infusion Pumps
Bioflex 2200- 665-1850 Vasculitis Kit
Getinge Steam Sterilizer
Leksell gamma Knife Perfexion
A) SDC HD Capture RecorderB) SDC HD Capture Device
Auto D Dimer Kit CRS 126B
Removable Magnet Hires 90K
BHR Streamline Cup Introducers
A) Intravenous Infusion Accessory IVMED20B) Intravenous Infusion Accessory IVMED60
A) Access Immunoassay System - TroponinB) Unicel DXI600 Access Immunoassay SystemC) Unicel DXI800 Access Immunoassa
Triniclot PT Excel, T1106
Galileo Echo Blood Bank Analyzer
Galileo Echo Blood Bank Analyzer
Oxidase Touch Sticks
Kryptonite Bone Cement
A) Signa 1.5T Excite HD - GradientsB) 3.0T Signa HDX MR System - Main UnitC) 1.5T Signa HDX MR System - HardwareD) Disco
Signa HDE 1.5T MRI System - Magnet
Dimension V-Lyte Integrated Multisensor
A) Unicel DXC600I Synch.Acc.Clin. AnalyzerB) Unicel DXC880I Synch.Acc.Clin. AnalyzerC) Unicel DXC660I Synch.Acc.Clin. Analyz
Buretrol IV Solution Adm.Sets Clearlink
Power Cord Component Of Sesmoid Plasty
CBC II Blood Conservation Kit
Kyphx HV-R Bone Cement
Model 7600 - Oximeter Pod
A) C-Series Clinac, Trilogy & Novalis Tx   B) Trilogy Radiotherapy Delivery SystemC) Novalis TX Linear Accelerator
Varis 4D Integrated Treatment Console
A) BD Q-Syte Extension SetB) MPS Acadia Extension Set With RightboreC) MPS Acadia Specialty Tri-Extension Set
Tg Gen.2 (Thyroglobulin) Assay
Duralite Pyramid Receiver Prox. Adaptor
Sequencer For Mosaiq
Triniclot APPT S, Cat. No. T1202
Triniclot APTT HS, Product Code T1204
A) Imager II Angiographic CathetersB) Imager II Catheters BERNC) Imager II Catheters SIMD) Imager II Catheters Contra2E)
Imager II Urology Torque Catheters
Washer Disinfectors
Pronto-Short Extraction Catheter
Koordinat M/MP
Vitrax II (Sodium Hyaluronate)
TECNIS 1-Piece Posterior Chamber IOL
A) Powerhart G3 Automated External Defibrillator B) Powerhart AED G3 ProC) Powerhart AED G3 PlusD) Powerhart G3 Plus A
A) Tegaderm Hydrocolloid DressingB) Medipore Soft Cloth Surgical Tape
EZManager Max Diabetes Management Software
OneTouch SureStep Test Strips
A) Navigation Software Knee ZimmerB) Brainlab Knee Essential SoftwareC) Brainlab Knee Unlimited Software
Dimension Vista System-Chem Calibrators
Siregraph CF
MRSASelect Referance 63747 Coffret 20 Plaque
Rapid Eric Electronic Compendium
Excor System-Connecting Set For Cannula
Diagnostic Ultrasound Transducers / Probe
i-CAT 3D Dental Imaging System
Twist Drill 1.1x50mm 3.5mm stop
Carto 3 EP Mapping System
i-CAT 3D Dental Imaging System
Triage Tox Drug Screen PN 94400
Galileo Echo Blood Bank Analyzer
Hintegra Talar Cutting Guides
Amplicor STD Specimen & Transport Kit
BD 30ml Luer-Lok Syringes
LabPro V3.01 Panel Update-01
Dade Hepzyme (B4240-10)
IW900 Series Infant Warmer
CyberKnife Robotic Radiosurgery System
A) Intro-Flex Introducer SetsB) Percutaneous Sheath Introducer Kit
A) VNS Therapy Demipulse Programmable GeneratorB) VNS Therapy Demipulse Duo Generator
A) System 1000 Dialsate Delivery System - AuroraB) System 1000 Dialsate Delivery System - TinaC) Arena SPP Hemodialysis De
A) Isolex 300I Magnetic Cell SeparatorB) Isolex 300 Magnetic Cell Separator
Stat G3+ Cartridges
LCT-1000 Therapy Laser
A) Advia CentaurB) Advia Centaur XP
Definium 5000 Digital Radiographic System
Chloride Membrane on ABL 700 & 800 Flex
Delfia Xpress PAPP-A Kit
Sur-Catch No Tip Nitinol Stone Basket
A) Nexgen Rotating Hinge Knee-Femoral ComponentB) Nexgen Rotating Hinge Knee-Tibial Component
A) Immunocap 250 Specific IGE ControlB) Immunocap 100 Specific IGE Control
Dual Offset Broach Handle Left and Right
Impression Coping Closed Tray Regular Platform 05x9mm
Flexicair
A) Cell-Dyn 1700 Analyzer/1700CS AnalyzerB) Cell-Dyn 1800 Analyzer
Powersail Coronary Dilation Catheter
Instrument Manager
Dimension Vista System-Urea Nitrogen Assay
M3 Micro-MLC For Varian With MLC
E-Cylinder Canister Holder
Digital Radiography Imaging System
A) 0.8% Resolve Panel A Reagent RBCB) 0.8% Resolve Panel B Reagent RBC C) 0.8% Resolve Panel C Reagent RBC
Quinton QStress TM55 Stress Treadmill
Exogen Bone Healing System
A) S3 Med/Surg Bed FowlerB) Secure II Med/Surg Bed Fowler
Dall Miles Trochanter Cable Grip System
Olympus Mobile Workstation, Transformer
Carendo Multipurpose Hygiene Chair
BD MultiSET Software V.3.0.1
Genesis II Femorals
Coonrad/Morrey Total Elbow System
Laparo-Thoraco Telescopes, Cable Unit
Architect I System-Total B-HCG Reagent
BHR Acetabular Cups
Trident Acetabular Surgical Protocol
Removable Magnet Hires 90K
A) Amplilink Software V 3.1.1B) Amplilink Software V 3.1.2 Build 0502C) Amplilink Software V 3.2D) Amplilink Software V 3.2.1E
Centricity PACS Workstation - Hardware
A) Central Venous Catheterization SetB) Central Venous Catheter
Accu-Chek Softclix Lancets
Kuschall K-Junior Manual Wheelchair
Stromatolyser-IM
NX 8000 With V. NX2008 Or NX.x.8000
Kodiak Power Supply
Acuson P50 Diagnostic Ultrsound System
Icelock expulsion valve 551
Stellant CT Dual Injector Systems P3T
A) Cancellous Bone ScrewsB) Gap Plate Screw
A) Restoration Modular Calcar BodiesB) Restoration Modular Hip Body/Bolt STDC) Restoration Hip Body/BoltD) Restoration Mo
Paradigm Quick-Set Infusion Sets
'903' Newborn Screening Cards
PCR AC-500/PCR AC-5000 Basic System
Apexpro Telemetry System - Transmitter
Hispeed FXi, LXi System
CIC Pro Clinical Information Center
A) Brilliance 40/64 Slice CT SystemB) Gemini TF PET/CT System
2.0 Compression L Plate, 6 Hole Left
A) Sabouraud Dextrose AgarB) Middlebrook 7H11 AgarC) TSA + 5% Sheep Blood (BA)D) Nitrient Agar
A) BHS 301B) BHS 202C) BHS 102 D) BHS 130E) BHS 301 SCULPTORF) BHS 302G) BHS 135H) BHS 140
A) Posey Soft Belt With Crotch StrapB) Posey Breezeline Pelvic Holder
Synchron Rheumatoid Factor (RF) Reagent
AW Volumeshare2 - CT Perfusion 4
Fetal Bleed Screening Test
A) Pediatric Emergency System KitB) Pediatric Emergency System Flying CarpetC) Emergency System Intraosseus Module
Fogarty Occlusion Catheter
Damon SS Archwire 227-1043
Synchromed II Implantable Infusion Pump
Tina-quant a Apolipoprotein A1
Trinical Reference Plasma T5102
Triniclot APPT S, Cat. No. T1202
Trinclot APTT HS, Product Code T1204
Varelisa MPO ANCA
A) Bypass TGH KitB) Valve TGH Kit
Clinac IX Radio Therapy Delivery System
Triage Tox Drug Screen PN 94400
A) Aeroset System - Total Bilirubin AssayB) Architect System - Total Bilirubin Assay
Brightview Gamma Camera Sy. w/ 3/8" Crystal & Detector Caudal Cephalic
Uniglide Femoral Component, Non-Cemented
Reusable Metal Needle Guides & Bushings
Sonara Transcranial Doppler System
Instatrak 3500 System
MIS Diamond Burs
Cyberknife Robotic Radiosurgery System
Smartmonitor 2 With PCMCIA
Twin-Pass Dual Access Catheter
Easylink Informatics System
A) Advia CentaurB) Advia Centaur XPUpdated recall # 49196 previously posted on 2009-07-06. / Mise à jour du retrait #
Factor V Leiden Kit on LightCycler 2.0
Operon D850/750/752/B810 Surgical Table
Welch Allyn AED10 Defib, MRL Jumpstart
Compax 40E Table
A) Cancellous Bone ScrewsB) Gap Plate ScrewUpdate recall # 49712 previously posted on 2009-08-03. Mise à jour du r
A) Vital-Signs Monitor with Rate and MapB) Vital-Signs Monitor with Rate/Map PrinterC) Vital-Signs Monitor with Rate/Map/Print
4.0mm Direct Measuring Gauge
A) Alaris Patient Care System-ID ModuleB) Alaris Patient Care System-Server ModuleC) Alaris Patient Care System-PCA Modu
A) Innova 4100 IQ - Main UnitB) Innova 2000 Cardiovascular System
A) Innova 4100 IQ - Main UnitB) Innova 2000 Cardiovascular System
Delta Ceramic Ball Heads
M Series Remstar Heated Humidifier System
Active Cortisol Enzyme Immunoassay Kit
3.0T Signa HDX MR System - Hardware
A) Stryker Pain Pump 120cc CathetersB) Infusion Sets For Stryker Pain PumpsC) Stryker Pain Pump 270cc CathetersD) Exfen
A) Dyonics Powermax Elite Motor Drive UnitB) Dyonics Mini-Motor Drive UnitC) Dyonics Power Ultralight Motor Drive
CyberKnife Robotic Radiosurgery System
Teleflex Medical Surgical Scissors
Anti-Cardiolipin IGM Test Kit
A) Tube Assembly 142, V2, V12, For DXC 600B) Tube Assembly 142, V2, V12, For DXC 800C) Tube Assembly 142,V2,V12, Fo
Versys Hip System Femoral Head
Staphaurex Plus 150/450 Test Kits
VGM 19" MonitorUpdated recall # 48079 previously posted on 2009-05-25. / Mise à jour du retrait # 48079 affliché le 200
Wellcolex Colour Salmonella
Oxidase Touch Sticks
A) Integrated Power Console (ENT)B) Integrated Power Console (NT)
Lasertek 5000
TDWorkstation Working With Sebia Hyris
A) CoaguCheck XS InstrumentB) CoaguCheck XS Plus Monitor
Elecsys Anti-CCP reagent Kit
A) Sheri-I-Bronch Endobronchial Tube KitB) Sher-I-SWIV Double Swivel Tracheal Tube
Heartstart MRX Defibrillator/Monitor
Lightwave Ablator IA-2000-S
Conmed Linvatec Arthro-Knife
Aquillion One
Clearview HCG
Sireskop SX/SDUpdated recall # 47071 previously posted on 2009-06-22.
Cook Sydney IVF Culture Oil
A) Van SonnenbergB) Flexima Hydrophilic All PurposeC) Flexima Hydrophilic DrainageD) Flexima Hydrophilic Biliary DrainageE
InterDry Ag
A) VNS Demipulse SYS ProgrammingB) VNS Demipulse SYS Programming Software
A) Gyroscan Intera ACS 1.5 Tesla MR System B) Intera 1.5T MR Systems - Coils
Aquesure Disposable Filters
Magna-FX Cannulated Screw Fixation
Hydrodissector Cannulas
Ultrapower Diamond Wheel Bur
Datex Ohmeda Carestations Interface
A) VNS Model 250 Programming SoftwareB) VNS Demipulse System Programming Software
HTA System
Hi-Art System
Clay Adams Dynac III Centrifuge
A) Anesthesia ManagerB) PACU ManagerC) Critical Care Manager
Pedicap / Pedicap 6
Warmer, Infant Radiant
G40, X150, X300 Ultrasound System
A) PKS Seal Open Forceps, Curved Jaw With CordB) Plasmakinetic Curved Jaw Open ForcepsC) Plasmakinetic Straight Jaw O
A) Expo Angiographic Catheters, amplatzB) Impulse Angiographic Catheter, amplatzC) Impulse Angiographic Catheter, brachia
A) Wiseguide Guide Catheters, bypassB) Wiseguide Guide Catheters, multipurposeC) Wiseguide Guide Catheters, q-curveD) W
MC5057 Universal Cable
Emax 2 Plus System - Foot Pedal
A) Brainscan Radiotherapy System-SoftwareB) iPlan RT Dose-Planning Software
A) Oximetrix 3 System SO2/CO ComputerB) Lifecare PCA 4100 Plus InfuserC) Lifecare 5000 Plum Infusion Pump System D)
Galileo 500ul Syringes
A) Screwplant ImplantsB) Screwplant Healing CollarsC) Legacy Healing CollarsD) Screwindirect ImplantsE) Screwplus Implants
Cobra Electrosurgical System
A) Portex Tracheal Tube, Oral/Nasal, IvoryB) Portex Tracheal Tube, SiliconisedC) Portex Tracheal Tube,Murphy,SiliconisedD) P
Capture-R Ready Screen (4)
HeartStart MRx Defibrillator/Monitor
Bond-1 Primer/Adhesive
Stratus OCT Tomographer Vers. 6.0 Software
A) Unicel DXI800 Thyroglobulin Antibody IIB) Access System Thyroglobulin Antibody IIC) Unicel DXI600 Thyroglobulin Antibady
Synchron CX Immuno-Protein Calibrator
Phenobarbital And Drug Calibrator 1
A) Multidiagnost Eleva-Flat DetectorB) Allura XPER FD10/10-Main Unit
Architect Reaction Vessel
Chemiluminescent Substrate
A) Vitros 3600 Immunodiagnostic SoftwareB) Vitros 5600 Integrated System Software
Prelude Short Sheath Introducer
VS Ventilator
A) Wiseguide Guide Catheter FemoralB) Wiseguide Guide Catheter AllrightC) Wiseguide Guide Catheter VodaD) Wiseguide Gu
PFC Sigma CR Non-Porous Left Femoral
Disposable Endoscopic Surgery Blades
Steris CMAX Surgical Table Hand Control
A) Picis OR ManagerB) Picis Preop ManagerC) Picis Anesthesia ManagerD) Picis PACU ManagerE) Picis Critical Care Manage
Instrument Manager
BD Falcon 100X20 mm Tissue Culture
Washer Disinfectors With Transformer
ASC 2000 Ambulatory Surgical Table
Dyonics 25 Tube Set Kits
Compax 40E Table
ZMR Hip System-Stems
2.7mm Cortical Screw Self-Tapping
Alumina Ceramic Femoral Head
A) Integris V5000/BV5000B) Integris H5000F Cardiology Imaging SystemC) Integris H5000C Cardiology Imaging SystemD) Inte
Carescape V100
Muse Cardiology Information System
CIC Pro Clinical Information Center
Hinged Knee Brace
Intellivue MP70 Patient Monitor System
Sireskop SX/SD
1.5T Signa Infinity MR Excite - System
Posey Buckle
Erytype S RH Donor Plates
Aria Radiation Oncology
A) Achieva 3.0T MRI System-Main UnitB) Achieva 1.5T MRI System-Main Unit
A) Avalon Fetal Monitor FM30-Main UnitB) Avalon Fetal Monitor FM20-Main Unit
Brilliance 6/10/16 Slice CT-SFRTWR Dent
A) Innova 2100 IQ Digital Imaging SystemB) Innova 4100 IQ System
Colleague Volumetric Infusion Pump
Light Wand Orotracheal Lighted Stylet
ReSolve Open Back Halo Ring
Process System Manager
Magellan Platelet Separator Disposables
Reservoirs
Cell-Dyn Sapphire Analyzer
A) Philips Multidiagnost Eleva - Image IntensifierB) Philips Multidiagnost Eleva - Flat DetectorC) Omnidiagnost Eleva
A) Origin YZ Zirconia BlocksB) Origin YZ Zirconia Discs
Precision Charger 1.0
Dri-Lok Disposable Cannulas
HM Reaction Vessels
Tenderflow Pediatric Arterial Cannula
Vertier Surgical Table
A) Simview 3000B) Simview NT Therapy Simulator
A) ErgoliftB) Ergolift-2
Servo 300/300A
A) Roche Hitachi - HDL CholesterolB) Hitachi HDL-C Plus, 3rd GenerationC) Cobas C/Integra HDL-C Gen. 3D) Cobas C 111 H
A) AutostainerB) Rabbit Monoclonal Antibody Clone SP3
Conform XT- Gloves
Autologous Platelet Concentrate System
STA-Neoplastine CI Plus 10
Hamilton Star Archive Plate
Anti-H Lectin
Intertan Entry Portal Handle
Medfusion Syringe Pump
QP2508 Hand Pendant
Biophen Heparin 6 ref 221006
ECC.O Integrated Mini-Bypass System
Trupath Biopsy Device
Maestro 3000 Cardiac Ablation Foot SWT
Nexgen Complete Knee Solution, Articula
Gold Probe Electrohemostatic Catheter
Soft Tip Introducing Sheath
Ximatron Digital Imaging 7.5.51 SP2Updated recall # 41318 previously posted on 2008-03-31.
Easydiagnost Eleva
Modular Femoral Neck
BiPAP Focus Ventilator Power Cord
A) Advia Centaur System-HIV Enhanced AssayB) Advia Centaur XP System-HIV Enhanced Assay
Staphaurex Plus 150/450
BD Integra 1mlTB Syringe
Ransel Kit
Simulfluor Flu A/B Immunofluor Assay
Gendex GXCB-500 Cone Beam 3-D Imaging
Urovysion Bladder DNA Probe Kit
Terumo Advanced Perfusion System 1
Bioplex 2200 Detector Calibration Packs
A) Liquicheck Cardiac Markers Control LT - TrilevelB) Liquicheck Cardiac Markers Control LT - Level 1C) Liquicheck Cardiac M
Carina Home Ventilator
Minute Lab PSA Semi-Quantitative Test
A) Achieva 3.0T MRI System-Main UnitB) Achieva 1.5T MRI System-Main UnitC) Achieva XR MRI System-Main UnitD) Intera 1
A) Voluson E8 Ultrasound SystemB) Voluson E8 Expert Ultrasound System
Giraffe Omnibed
Rear Case Assembly For Auto Syringe
Durepair Dura Regeneration Matrix
Galileo Echo Blood Bank Analyzer
Prosolv Cardiovascular Image and Information Management
A) Innova 2100/2100 IQ Digital MonitoringB) Innova 4100 IQ
A) Evita 4B) Evita 2 DuraC) Evita XL
A) Securefit Hip Stem - 132 degreeB) Securefit Hip Stem - 127 degreeC) Solar Shoulder - Humeral ComponentD) Osteonics Om
Access Immunoassay Systems Inhibin A
Innova 2121 IQ
Vibe Machine
TD-Synergy Software (TD-SYN-01)
A) Osteonics Omnifit M-HA Hip StemB) Accolade TMZF Press Fit Stem 132 DegreeC) Accolade TMZF Press Fit Stem 127 Degree
A) HLA Typing TraysB) HLA Typing Trays - B-27C) HLA Typing Trays - Class II
A) Axiom Artis DBAB) Axiom Artis DTAC) Axiom Artis DMPD) Axiom Artis DBCE) Artis Zee Multi-PurposeF) Artis Zee CeilingG) A
A) AMX 4 Mobile X-ray SystemB) AMX-4+ Mobile X-ray System
2.0mm Stainless Steel Crimp Sleeve
A) Sterile ECLS PackB) Sterile Lap Chole PackC) Sterile Lap Chole PackD) Ens. Strl. Pour SternotomieE) Sterile Major Laparoscop
A) OEC Mobile Elite C-Arms Gen. PlatformB) OEC Mobile Elite C-Arms Cooling
Wizard Low Profile Gastrostomy Device
A) Advia Centaur XPB) Advia Centaur
Oxylog 3000 Ventilator
Diamond Mammography X-ray Equipment
Centricity QS Perinatal System
A) Gemini GXL 6/10/16 Slice PET/CT SystemB) Gemini TF 16 PET/CT SystemC) Gemini TF 64 PET/CT System
A) Advantage Workstation Version 4.2B) AW VolumeshareC) AW Volumeshare 2
Floseal Endoscopic Applicator
Aisys Anesthesia Carestation
Duralite Pyramid Receiver Proximal Adaptor
A) Easy Core Biopsy SystemB) Easy Core Biopsy Needle - Delta Notch
Synfix LR, Low Profile U-Joint Driver
Artiste MV
Miltex Stainless Steel Surgical Blades
3160 MRI Sytem-Power Battery Components
Signa 3.0T Excite HD - Magnet
Ponsky Non-Balloon Gastrostomy Tube
A) Capture-CMV Indicator Red CellsB) Capture-S Indicator Red Cells
Fuji Synapse Image & Information System
Unicel DXC 880I Synchron Access Clinical System
Precision Spinal Cord Stimulation System
A) Axis Variable-Angle Dual-Detector GammaB) Irix Triple Detector Camera
CGMS IPRO System - Solutions Software
Ceiling Tube Mount With Column Extensions
Steerocath Steerable Catheter Non Temperature
Patient On-Line
A) 3.0T Signa HDX MR System - Main UnitB) 1.5T Signa HDX MR System - Main Unit
A) Uroview 2800 System - Urological TableB) OEC Miniview 6800 Digital Mobile UnitC) OEC Flexview 8800 Standard C-ArmD) O
Modular Microplasty Cup Inserter
Centricity PACS Workstation Software
A) Solar 8000I System - Patient MonitorB) Patient Data Module
Datex-Ohmeda Network Aand Icentral
A) Immulite 2000 System-Analyzer Class IIIB) Immulite 2000 System-Analyzer Class IIC) Immulite 2000-Instrument Class IV
Bremer Halo Mayfield Adapter
Sterrad 50 Sterilizer
Philips Bougie
Stille Sonestra 6210 Fluoroscopy Table
Oxoid Fraser Broth Base
A) Variant II System with CDM 3.5 softwareB) Variant II Turbo with CDM 3.6T System
Elekta Precise Treatment Table
Unisplint, Maxillofacial Fracture Kin
Vitros DT Calibrator Kit
Logiciel TDHisto/Cyto Software
A) Engstrom CarestationB) Engstrom Carestation - Trolley Options
Aquarius System
Minimally Invasive Solutions Technology Offset Rasp Handles
CoCr Head 0 32/+4L Taper 12/14
Aquilion One
A) Coonrad-Morrey Total Elbow - HumeralB) Coonrad-Morrey Total Elbow - Ulnar
Abbott Prism HBsAg
9-10mm Ezloc Femoral Fixation Device
Triathlon Primary Cemented Baseplate
Triathlon Primary Cemented Baseplate
Octeia 25-Hydroxy Vitamin D Kit
Vasoview 6 Endoscopic Vessel Harvesting
Heartstring II Proximal Seal System
Fastrac "Pull" Gastric Access Port Kit
Focal Software CD
Cytomics FC 500 Flow Cytometry System
A) Sterile Pacemaker and Defibrillator PackB) Sterile Shoulder Pack
Enzymatic Creatinine Assay
Amsorb Plus Prefilled Bubble-Can Universal WTOV
Blood Tubing Set for Hemodialysis
A) PDSII (Polydioxanone) Monofilament SutureB) Coated Vicryl Absorable SutureC) PDS II (Polydioxanone) SutureD) Monocryl
A) Brilliance CT Big Bore System - Main UnitB) Brilliance CT Big Bore System - Workplace
Hemodialysis Blood Tubing Set
Legion Press Fit Stems
Tandem Unipolar 46mm Femoral Heads
A) Colleague Volumetric Infusion PumpB) Colleague 3 Volumetric Infusion PumpC) Colleague Guardian Enhanced CXE PumpD)
Pip Fixation Hinge Kit
Vanguard Width Checker 67.5/70/75
Kwiktrak Gate System
TD-Synergy Version V03.11.A and above
Roche Hitachi D-Dimer
A) Lifepak CR Plus AED (Fully Automatic)B) Lifepak CR Plus AED (Semi-Automatic)
Cobas Ampliprep Vibration Dampers
DenOptix QST
Head Rest
Single-Use Sterile Puncture UA1256-U
Vcare Uterine Manipulators
.014 Damon Cu NiTi Archwire
Ondal Stryker Vision 3 Elect Mon Shroud
Access Systems Intact PTH Calibrator
Premise Unidose
Maxi Move w/ Lock & Load System
Power Tube
A) IR 1200 Insulin Infusion PumpB) Animas 2020 Insulin Infusion PumpC) Animas 2020 Replacement SKU (Black Only)
GE Centricity PACS Software
A) Quadrapolar DBS Lead KitB) DBS Lead
A) Syngo Dynamics Server SW V6.0B) Syngo Dynamics Workstation SWV5
Ondal Flat Panel/Navigation Arm
Lactosorb 1.5MM 8Hole STR EXT Plate
Siltrax Plus 8 Gingival Retraction Cord
A) Synchromed EL PumpB) Synchromed II
Syngo Imaging
ASP Automatic Endoscope Reprocessor
Vista Wound Vaccum System
Clinical Chemistry Bilirubin Calibrator
Cell-Dyn Sapphire Aanalyzer
3-0 Nylon Suture Products
Micromedics Drugs Of Abuse Panel Test
Coulter Act 5DIFF Fix Reagent
M2000SP INSTRUMENT (G Series)
Holter Reporter Master VII Analyzer
Medrad 3.0T Prostate eCoil
Hi-Art System - Kit-Power
MGC Diagnostix EDDP Panel Test
Somatom Sensation/Cardiac 64
Connecting Straps Belts Locking Cuffs
ILAB Ultrasound Imaging System
Prepstain System
Definium 8000 OTS
Terumo Advanced Perfusion System 1
Level Sensor Transducer
A) BD BBL Trypticase Soy AGAR PlatesB) BD Trypticase Soy AGAR With Lecithin
BD Directigen EZ Flu A+B
Ferno Model 35X Proflexx Stretcher
HeartMate II percutaneous lead
Enzymatic Creatinine ECRE Flex REAG. CART
Sternal Fixation System - Cable Ferrule
Dimension Vista 1500 V-Lyte Multisensor
A) Unicel DXC 600I Assay Protocol FileB) Access Immunoassay System Protocol FileC) Access System 2 Protocol FileD) Sync
Gambro Prismaflex System
Genesis II Tibial Baseplate Size 4
Syngo Multi Modality Workplace
26" Vision Elect HDTV Surgical Monitor
A) System 6 Trigger Rotary HandpieceB) System 6 Reciproc/Sternum/Sagittal SawsC) System 6 Precision Saw
Simile Dental Composite
Phoenix Hemodialisis Delivery System (Updated recall # 42906 previously posted on 2008-07-21. Mise à jour du retrait #
Arjo Maxi 500
A) Delta Xtend PE Humeral Cup High MobililtyB) Delta Xtend PE Humeral Cup, RetentionC) Delta Xtend PE Humeral Cup, Stan
Potex Blue Line Ultra Tracheostomy Kit
A) Navistar RMT DS CatheterB) Navistar RMT Thermocool Catheter
A) Synchron Cholinesterase ReagentB) Synchron Liquid Chemistry Control
A) Halo 360 Sizing BalloonB) Halo 360+ Ablation Catheter
Axiom Luminos DRF
Carelink Monitor, Optivol Carealert
Vitros System - Calibrator Kit 10
Variant II Turbo Hemoglobin System
RT240 & RT340 Adult Breathing Circuit
Arjo Maxi 500
Varelisa U1RNP Antibodies Kit
Symbia T Series
BAS G Tube Kits With Lube Jelly
A) OrtholockB) Navigation PinC) Ortholock EX
A) Unicel DXI 800 Class 3 Peristaltic PumpB) Unicel DXI 800 Class 2 Peristaltic Pump
A) Wallace Oocyte Recovery SetsB) Wallace Oocyte Recovery Needles
A) Stryker Secure 2B) Epic+C) Zoom Beds
A) Dyonics 25 Fluid System Inflow TubesetB) Dyonics 25 Inflow/Outflow TubesetC) Dyonics 25 Patient Tubeset
HeartMate II LVAS percutaneous lead
Intercept Micro-Plate EIA Kit
Hi-Art System - Kit - Power
Pacing Lead Adaptors Model C/IS-10
A) IV Neonate Statlock KitB) SL PICC Neonate Statlock Kit
C-Flex Endoureteroscopy Stent Set
Corqc Test System
SMV DST-XL
Foot Switch Triple
Galileo Echo Blood Bank Analyser
Advanced Perfusion System 1 Roller Pump
Advanced Perfusion System 1 Roller Pump
Advanced Perfusion System 1 Base Unit
WB Corqc
A) InteleViewer module of the IntelePACSB) InteleViewer Workstation
Curlin Painsmart Pump
A) EGM-Essential Gas ModuleB) Intellivue MP30 Patient Monitoring Sys.C) Intellivue MP50 Patient Monitoring Sys.D) Intellivue
Envision E700 Low Airloss Therapy
Vitros Chemistry Products Prot Slides
A) Liko Uno 100 Patient LiftB) Liko Uno 102 Patient LiftC) Liko Uno 101 Patient Lift
Accelerator APS System Input/Output Module (IOM)
Access Immunoassay Systems Accutni QC
Access Immunoassay Systems Digoxin
A) Axsos ScrewdriverB) Axsos Torque Limiter
Colleague Volumetric Infusion Pumps
TD-Synergy Software (TD-SYN-01)
Architect c16000
HeartMate II Left Ventricular Assist System
A) Carotid Shunt Outlying With T-PortB) Carotid Shunt Inlying With T-Port
Updated recall #37014 previously posted on 2007-09-17. Mise à jour du retrait #37014 affliché le 2007-09-17. A) Lifequest
Cobas ISE International Standard Gen.2
Pain Pump 2 Blockaid
West Nile Virus IGM Capture Elisa
Disposable Norothermic IV Admin. Sets
Filteredhorse Serum
Syngo Dual Energy Viewer
A) Mevatron KD-2B) Mevatron K-ClassC) Mevatron M And PrimusD) Mevatron MXE-2E) Mevatron KDS-2F) Mevatron MX-2
Sequencer
LSI FUS Dual Colour Breakapart Probe
VP 2000 Processor
Amoxicillin/Clavulinic Acid 30 UG DISC
Infectious Mononucleosis Kit
A) Giraffe Bedded WarmerB) Panda Ires Bedded Warmer
E.Coli 0157 Latex Kit
Acuson X300 Diagnostic Ultrasound System
Artiste MV Linear Accelerator
Graft Cutting Block With Scale
Battery Model NDA 0200-20
Sterrad 100S Sterilizer
A) Roche Hitachi - HDL-CholesterolB) Hitachi HDL-C Plus, 3rd Generation C) Cobas C/Integra HDL-C Gen.3D) Cobas C 111 H
ABL Calibration Soln 944-024, S1720
Revolution Formula 2 shade B2
Maquet Foot Paddle
Therapulse ATP
A) Deltec Cozmo 1800 Infusion PumpB) Deltec Cozmo 1800 Infusion Pump - DemoC) Deltec Cozmo 1800 Infusion Pump - Rece
Patient Registration Mask (Box Of 5)
A) Advia Centaur XP SystemB) Advia Centaur System
Synfix LR, Low Profile U-Joint Driver
Irma-Count SHBG Kit
Take 1 Advanced Volume FS
BMC RF Canula
A) Allura XPER FD10/10B) Allura XPER FD20/10 SystemC) Integris H5000C Cardiology Imaging SystemD) Integris Allura E) Allura
Process System Manager
A) Aquilion 32B) Aquilion 64
Aquilion One
Multi Diagnostic Eleva-Flat Detector-IM
Flexi-Seal FMS Advanced Odor Control
CELL-DYN Ruby Analyzer
Reflection Hip PE Inlay
Dimension Vista 500 System-Ferritin Assay
Irma-Count SHBG Kit
Philips Bougie
Vitek 2 GN Card
Allura XPER FD10
A) Allura XPER FD20/10B) Integris H5000C Cardiology Imaging SystemC) Integris AlluraD) Allura XPER FD10E) Allura XPER FD20
A) Ext. Sterilizable Paddles, Lifepak 9&9PB) Ext. Sterilizable Paddles, LP 12/20/20E
Accelerator APS Centrifuge Module
Easydiagnost Eleva
A) Lactosorb Endobrow Lift CompleteB) Office Fixation KitC) 1.5/IMF Small Office Set
Voyager RX Coronary Dilation Catheter
Careguard Mattress
Brilliance CT Big Bore System-Main Unit
XIO Radiation Treatment Planning System
A) Chemistry Controls For Advia 1800B) Chemistry Controls For Advia 1650C) Chemistry Controls For Advia 2400D) Chemistry
DLP Pericardial/Intracardiac Sump
Liaison System - Instrument Class 2
A) Endopath Electrosurgery Probe Plus IIB) Endopath Electrosurgery Probe Plus IIC) Endopath Electrosurgery Probe Plus II
Animas ezManager Plus Software French version
Kinair IV
A) Intouch Critical Care Bed Model 2130B) Intouch Critical Care Bed Model 2140
A) Intouch Bed Model 2130 With PositionproB) Intouch Bed Model 2140 With Positionpro
Heliobacter Pylori/IgG Enzygnost
Eclipse Treatment Planning System
On-Board Imager
Observa Data Management System
Vamp Jr Pediactric Venous Arterial Sys.
BD Vacutainer Blood Collection Tubes
Posey Synthetic Leather and Biothane Waist and Wrist Constraints
K3 Files
Varian Medical Varis Treatment System
Varian Medical Varis Treatment System
Galileos 3D X-Ray With Galaxis 1.5
Cerec 3 / inEos Camera
Elecsys Free T3
Vacuette Lithium Heparin Blood Collection Tube
Custom Sterile Procedure Pack
A) Spacelabs Healthcare 90496B) 91496 Command Module
A) Fiber Optic SigmoidoscopeB) Insufflation Bulbs
Light Wand Orotracheal Lighted Stylet
Access DHEA-S Reagent
A) Caire Liberator Base UnitsB) Caire Portable Units
Galileo/Capture-R Ready test wells
Galileo Echo/CaptureR Ready-Scrn strip
A) Aquilion 32B) Aquilion 64C) Aquilion One System-Main Unit
Outback Ltd Re-Entry Catheter
A) Cobas Integra System - AmphetaminesB) Roche Hitachi - Online Amphetamines
West Nile Virus IGG Indirect Elisa
Nepfrocare Software
A) Axiom Artis DTA B) Axiom Artis DMPC) Axiom Artis DBC
A) AcuityB) Ximatron
Access Systems HAV AB Calibrator
Access Systems FT4 Calibrator
Axiom Aristos FX
A) Attain LDS Left Heart Delivery SystemB) Attain Access Left Heart Delivery SystemC) Adjustable Hemostasis Valve
A) Sonoline G60 SB) Sonoline G50
A) Sonoline G60 SB) Sonoline G50
Lifepak CR Plus-AED (Fully Automatic)
Ophit DVI Extender
35-A Mobile Transporter
BD 5ml & 10ml Luer Lok Syringe Bulk
A) 12.6mm Boring ToolB) 9.5mm Boring Tool
Xpect Giardia/Cryptosporidium Kit
Opengene Software For Trugene HIV-1 Genotyping
A) ImmuliteB) Immulite 1000
A) HOL ML Clips & HOL L ClipsB) Titanium Clips, Small, Medium & LargeC) Horizon Titanium ClipsD) Hemoclip Plus, Sml, Med,
Accelerator APS Centifuge Module
Ena Elisa Test System
C-Series Clinac Linear Accelerator
A) Immulite 2000 System - C-Peptide AssayB) Immulite 2500 System - C-Peptide Assay
Immulite 2000 CEA
Lifepak 1000 Defibrillator
Custom Sterile Total Joint Pack
A) Mevatron KD-2B) Mevatron K-ClassC) Mevatron KDS-2D) Mevatron MD-2E) Mevatron MXE-2F) Oncor Impression IMRT Plu
Houva III
Gentle Touch 70mm Colo/Ileo PostOp kit
Iron (Total) Assay
IntraStent LD Max
PAR TDM-MAS Controls
ALN Vena Cave Filter / Introduction Kit
Vitros 5,1 FS Chemistry System
Paradigm MZ100 Block For Cerec
Selenia Full Field Mammography System
Bravo PH Capsule With Delivery System
Liquicheck Sedimentation Rate Control
A) Integra CocaineB) Cobas Gentamicin
A) Recip Blade 40MM LengthB) Abrader BladeC) Free Hand Saw Blade Micro ChoiceD) Large Bone Repeat Sternotomy BladeE)
Certain Microminiplant Healing abutment
Clinac High & Low Energy
Varis 6.2, 6.6, & 8.0
DOS-Based System 83 Plus
Locator Abutment
Vitek GPS Quinupristin/Dalfoprist Cards
Eclipse Treatment Planning System
A) Medi-Lifter III Plus Patient LiftB) Summit "Combination Walker"C) Summit With Mast ScaleD) Summit-2 With Mast Scale
Dimension TPSA Flex Reagent Cartridge
Elekta Precise Treatment Table
A) Advia Centaur SystemB) Advia Centaur XP System
Needle Tapered Hub & Thin Tip 30 Degree
A) Isomed Infusion PumoB) Synchromed EL Infusion PumpC) Synchromed II Infusion Pump
BCI 6004 Mini-Torr Plus NIBP Monitor
Lasso Variable Deflectable CIR Map Catheter
A) Hall Easy-Fit Prosthetic Heart Valve - AorticB) Hall Easy-Fit Prosthetic Heart Valve - Mitral
Levitronix CentriMag Systems
Given Diagnostic System with PillCam
Acuson Antares
Magnetom Harmony
Custom Sterile Hip Pack
Oxylog 3000
Triage MeterPro
A) Hemovac Autotransfusion Systems,VariousB) Surgivac Systems, Various C) Hemovac Systems, Various
Gambro AK-95 (Updated recall # 36667 previously posted on 2007-08-20. Mise à jour du retrait # 36667 afflichè le 2007-0
Cross Cut Fissur Bur
Clintest HCG Pregnancy Test
A) Liquicheck Cardiac Markers Level 1B) Liquicheck Cardiac Markers Level 2C) Liquicheck Cardiac Markers Level 3D) Liquiche
Updated recall # 41183 previously posted on 2008-03-31. Mise à jour du retrait # 41183 affliché le 2008-03-31. A) Aequalis
Updated recall # 41183 previously posted on 2007-08-061. Mise à jour du retrait # 41183 affliché le 2007-08-06.Atlantis Pa
A) Intelect Advanced Therapy SystemB) Intelect Legend XTC) Intelect Mobile UltrasoundD) Intelect Transport Ultrasound
Ergoscale Scale And Swivel Bar
Amplatzer PFO Occluder
A) i-CAT 17-19, 3D Dental Imaging systemB) i-CAT Classic
AUSAB EIA
Suresigns VS3 Vital Signs Monitor
Statstrip Glucose Hospital Meter
A) Wrist Stabilization Kit - SmallB) Wrist Stabilization Kit - MediumC) Wrist Stabilization Kit - Large
Triglycerides
Brilliance CT 16 Power Slice
A) Gemini GXL 6, 10, 16 Slice PET/CTB) Gemini TF 16 PET/CT SystemC) Gemini TF 64 PET/CT System
A) Contak Renewal 4B) Contak Renewal 4 HEC) Vitality 2 DRD) Vitality AVTE) Vitality DRF) Vitality VR
A) Affinity Two Birthing Beds P3600 SeriesB) Affinity Birthing BedsC) Affinity Birthing Beds P3600 SeriesD) Affinity Four Birthin
A) Epker Osteotome (Slightly Curved)B) Epker Osteotome (Straight)
Elecsys Progesterone II
CT 9000 ADV Injector With Console
Optivantage DH Power Injection System
Varient B-Thalassemia Short Program
Blood Grouping Reagent Anti-S
N Latex CDT Kit
Lupine BR Anchor With Orthocord
FlexCath Steerable Sheaths REF#2FC12
Hill-Rom 100 Low Beds
Precinorm And Precipath U Plus Controls
A) Dermacarriers Skin Graft CarriersB) Dermacarriers II Skin Graft Carriers
Clinical Chemistry Iron/Magnesium Calibrator
Syngo Dynamics
A) LTV 800 Series VentilatorB) LTV 950 Series VentilatorC) LTV 900 and 1000 Series Ventilators
Myotrac Infiniti SA9800
A) Mevatron KD-2B) Mevatron K-ClassC) Mevatron KDS-2D) Mevatron M-Basic UnitE) Mevatron MD-2F) Mevatron MX-2G) M
Dimension Extended Range CRP
Odissey Tissue Oximeter Patch Sensor
Haemophilus Selective Agar
A) I-CAT 17-19, 3D Dental Imaging SystemB) I-Cat 3D Imaging System - Main Unit
A) Sterile Mammoplasty PackB) Sterile Total Knee PackC) Othopedie-Fusion Posterieure
SDC Ultra
Pegless Universal Scorpio Notch Guide
BD Tensor Heat Therapy Patch
A) Endopath ETS White Reload For ATW35B) Endopath ETS 35MM Endoscopic Linear CutC) Endopath ETS Endoscopic Linear C
Hilal Embolization Coils
G60S Diagnostic Ultrasound System
Gambro Cartridge Set for Phoenix
A) Sterrad 100S SterilizerB) Sterrad 50 SterilizerC) Sterrad NX Sterilizer
A) Lifepak Internal Defib. ElectrodesB) Lifepak 9 & 9P Int. Defib. HandlesC) Lifepak 12 & 20 Int. Defib. Handles
Balloon Temporary Pacing Catheter kit
Fastpak Battery
Elekta Synergy (Updated recall # 41727 previously posted on 2008-04-14. Mise à jour du retrait # 41727 affliché le 2008
Kyphx HV-R Bone Cement w/ Kyphon Mixer
Aquillion One
Cell-Dyn Sapphire LIS/Middleware Interface Specification (Revision B)
A) Diagnost 76 Plus FamilyB) Easy Diagnost Classic FamilyC) Easy Diagnost Eleva Family
Quanta Lite B2 IGG Kit
A) Advia Centaur SystemB) Advia Centaur XP System
 Level Sensor II Pads, Gel Included
Autoxpress Platform System - Bagset
Isite Ipacs
XIO Radiation Treatment Planning System
A) Corqc Test SystemB) Panoscreen I/II/III
HL 30 Perfusion System
Affinity NT Hollow Fiber Oxygenator
Gambro Cartridge Blood Set
OEC 9800
Protime Microagulation System
Stratus CS CCTNI Calibrator
A) Advantx LCLP+ Bi Plane Cardiac SystemB) Advantx LCN+ Angiographic SystemC) Innova 2000 Cardiovascular SystemD) In
MIM Software 4.0.2-4.0.5, 4.1.0-4.1.2
Infravision Urethral Kit
Innova 2100IQ
Quick Connects
A) Sterile Line PackB) Sterile Primary Spinal PackC) Sterile Cardiovascular Universal
Oncor Expression
Somatom Definition
Coulter LH SlideMaker
Precision RX/I Remote Imaging System
Magicview 300
A) Mevasim-SB) Simview 3000C) Simview NT
Trinity Biotech D-Dimer High Control
FP 1000 Cell Preparation System
Dimension Automated LDL Calibrator
A) 4 MM Stella OsteotomesB) 6 MM Stella Osteotomes
A) Mevatron K-ClassB) Mevatron M And PrimusC) Mevatron MD-2D) Oncor ExpressionE) Oncor Impression IMRT Plus
Palmsat Pulse Oximeter
A) Advia 120B) Advia 2120
Drystar Axys
Elekta Precise Treatment Table
Cell-Dyn 3500 CS/SL,Cell-Dyn 3700 CS/SL
A) Advia 1200 Chemistry SystemB) Advia 1650 Chemistry SystemC) Advia 1800 Chemistry SystemD) Advia 2400 Chemistry Sys
MMT-522 Paradigm Real-Time Insulin Pump
Lifepak 12 Defibrillator/Monitor
Nexgen Complete Knee Solution Articular SurfaceInsertion Instrument
Smart Control Nitinol Stent System
Collimators
Myoglobin Control Set
A) Integrated Trillium CVR/OxygenatorB) Trillium Affinity OxygenatorC) Custom Tubing Packs With TrilliumD) Sterile Trillium Af
Axsym Digoxin II Reagent Pack
Monaco
RPM Respiratory Gating System
Mirror Defogger
Medley Pump Module
Bioplex 2200 system - instrument
VARIANT II Turbo Hemoglobin Test. Syst.
Amplicheck Swab CT/GC Control A positif
Coagucheck XS PT strips 2x24,24,6 tests
Cobas Integra Lipase Colorimetric lipc
A) 1000 LB ScaleB) 300 KG, Class 3 ScalesC) 800 LB ScaleD) Ergolift With Scale
Animas 2020 Insulin Pump User Guide
Allura XPER FD20 System
Surgical Suction Pump
A) BV EnduraB) BV Pulsera
Maxxum Hi/Lo Bed
Calibrite APC Beads
BD vacutainer push button blood coll.
BD difco shigella antiserum poly groupb
A) Home Choice Automated PD SystemB) Home Choice Pro Automated PD System
Infusor 2mL/HR
Tape fog shield surgical mask green fib
A) Advia Centaur System-Class 3B) Advia Centaur XP System-Class 2C) Advia Centaur XP System-Class IVD) Advia Centaur XP Sy
A) Universal ElectrodesB) Ultraclean Electrodes
bd visitec nucleus hydrodissector
CH3/ETOH/CO2 Calibrator and Controls
A) +16mm cocr femoral head B) +16mm cocr femoral head
A) ACAT/AUTOCAT2 Intra-Aortic Balloon PumpB) ACAT/AUTOCAT2 Intra-Aortic Balloon Pump
bbl cystine trypticase agar with maltos
peel-away introducer sets
A) Aquilion 32B) Aquilion 64C) Aquilion Super 4D) Toshiba 256-Slice Scanner
Transilluminator, BF-150
CS100 Intra Aortic Ballon Pump
Mevatron Linear Accelerators (Updated recall previously posted on 2007-11-12 / Mise à jour de ce retrait affliché le 2007-
Modular Replacement System, Distal Fem.
Goldbal Detachable Balloons
Ultrasound Handpiece Swiss LithoClast
VISX Star Excimer Laser System
Accutrend GC (Multiple Patient Use)
Limblogic VS 4 Hole Kit
HerpeSelect 1 and 2 Immunoblot IgG Kit (Update/Mise à jour)
A) Kodak Directview DR3000 System 64KW GENB) Kodak Directview DR3000 System 80KW GEN
Pectus Table Top Bender
E Series Defibrillator with 12 Lead ECG
A) Dura Star RX PTCA Dilation CatheterB) Fire Star RX PTCA Dilation Catheter
A) Trident acetabular shellB) Trident acetabular shell solid-dome holeC) Trident hemispherical cluster hole shellD) Trident hem
Trial Heads (Updated recall # 39231 previosly posted 2008-01-21. Mise à jour du retrait # 39231 affliché le 2008-01-21)
Endoscopic Ligating Clip Applier (ELC)
Leksell GammaPlan 8.0
A) BEP III System ReconditionedB) BES Software Release 3.3C) BEP III System
RPM respiratory gating system
TD-Synergy V03.11.A,
Aquilion (Update/Mise à jour)
Precise Treatment Table
Dimension Urea Nitrogen Flex Reagent
FT420T-FT430T Caspar Aneurysm Clips APP
Multigent Vancomycin Reagent
Cell Dyn Sapphire Analyzer
Axsym Drugs of Abuse/Tox Disk V8.0
Elekta Precise Plan
Cell-Dyn Sapphire Software
A) Cell-Dyn 4000 WBC ReagentB) Cell-Dyn Sapphire - WBC Reagent
A) Atlas + DRB) Atlas + HFC) Atlas + VRD) Atlas II + DRE) Atlas II + HFF) Atlas II HFG) Atlas II VRH) Epic + DR ICDI) Epic + HFJ) Epi
Fabius GS
Graseby 3000 Volumetric Pump
Clinician's Programmer Navigator V1.02
IMMAGE C-Reactive Protein CRP Reagent
Stryker Burs
Streptex Test Kit
Syngo Dynamics
Lithoskop (Updated recall # 37262 previously posted on 2007-09-17. Mise à jour du retrait # 37262 affliché le 2007-09-17)
Blood Grouping Reagent Anti-Le Bioclone
Allofit Shell Size 50
3.5MM ULS Instrument And Implant Case
Metasul LDH Large Diameter Head
Focal Workstation
Pulsavac Plus Wound Debridement System
Evotech Endoscope Cleaner & Reprocessor
A) Sterile Bowel Resection-Lithotomy PackB) Major Surgery Packs
Microjack Patient Interface
Pericardial Sump
Hemovac Infection Control Kits
Coagucheck XS PT strips 2x24,24,6 tests (Updated recall # 39425 previously posted on 2008-01-07. Mise à jour du retrait #
Cadd Medication Cassette Reservoirs
Clinical Chemistry Phenytoin
Deltec Cozmo Insulin Pump, MDL 1700&1800
Dimension MicroabuminI (MALB) Calibrator
Complement Reagents
Pulsavac II & Pulsavac III
Leonardo Workstation
Mystic II Pump with M-Style Mushroomcup
Capture-R Ready-ID
A) Kion & AccessoriesB) Kion-I-Aanestthesia WorkstationC) Kion-I-Base Unit
Jostra Heater-Cooler Unit 30 System
ABL80'S With Software Version 1.10
Ceramic Femoral Head
Coulter LH Slidestainer/Slidemaker
A) Liquid Assayed MultiqualB) Liquid Unasseyed Multiqual
Tomotherapy Hi-Art System
Olympus AU2700 Immunochem System Analyzer
Avoximeter 1000E Oximeter
Perfektum Toomey Evacuating Syringe
C1160 Tray used with Steris System 1
A) O-Arm 1000 Imaging System-Control Pend.B) O-Arm 1000 Imaging System - Main Unit
Pinnacle 3 Radiation Therapy Planning System
A) Brilliance 40/60 Slice CT SystemB) Brilliance 40/60 Slice CT System - EWBC) Brilliance 64 Slice CT System - EWBD) Brilliance
Accu-Chek Inform Base Unit
Tenzor Carbon Fiber Orthopedic Traction
Biograph 16
Navistar RMT Diagnostic/Ablation Catheter
A) Carevue Chart Release C v.C.00.00 - 06B) Intellivue Clinical Info Portfolio D
A) Universal ElectrodesB) Ultraclean Electrode
Flo-2 Kit With Mask
Liquichek Speciality ImunoAssay CTRL
Captia VZV IgM Elisa Test
Amsco Remaufactured Prevacuum Sterilizers
Icy Hot Heat Therapy
Immunocard Toxins A&B
A) Aequalis Shoulder - Kelled GlenoidB) Aequalis Shoulder - Cemented GlenoidC) Latitude Elbow Prosthesis CapD) Latitude El
BCI 3180 Pulse Oximeter
A) Mevatron K-ClassB) Mevatron PrimusC) Mevatron MD-2 D) Oncor ExpressionE) Oncor Impression IMRT Plus
Deltec Cozmo Insulin Pump, #1700 & 1800
Single-Stage Implant System 122-800 Kit
Elekta PrecisePlan
iViewGT Electronical Portal Imaging
A) Sigma 8000 Infusion PumpB) Sigma 8002 Infusion Pump
A) Maxi Sky 600 Ceiling LiftB) V4 Ceiling LiftC) V4i Ceiling Lift
IgM HRP ELISA Kit
Clinacs with Type 3 Accessories.
ON-Q C-bloc
Ximatron Digital Imaging 7.5.51 SP2
ON-Q PainBuster, 270 ml x 5ml / hr
Biohorizons Implant System Ratchet Extender
Immunocard C. Difficile
Roller Pump for Sarns Modular Perfusion
A) Phaseal Injector N31B) Phaseal, Protector 14-21-50
A) Biograph Duo LSOB) Biograph 6C) Biograph 16
Heartstart XL Monitor/Defrillator
Cryocheck Normal Reference Plasma
Reagent RBC Resolve Panel A
RDE(II) Seiken
Nova 8 Calibrator Pack
A) Dimension Chemistry System - Dimension XL, RXL, RXL MAX Software B) Dimension X-Pand System - XPAND, XPAND PLUS S
Ambu Peep 10 Resusable Valves
Neisseria Meningitidis Antisera Group Y
Clinitubes
Gluma Comfort Bond and Desensitizer
Phaseal, Protector 14-21-50
Digital Linear Accelerators
A) Mevatron Linear AcceleratorsB) Oncor ExpressionC) Oncor Impression
C.Cam Imaging System
Accu-check Ultraflex II
A) Troponin Ultra (TNI-ULTRA) AssayB) Troponin Ultra (TNI-ULTRA) AssayC) Troponin Ultra (TNI-ULTRA) Assay
A) Mevatron Linear AcceleratorsB) Oncor ExpressionC) Oncor Impression
Immunocard C. Difficile
Observa software
M5000 Pagewriter Touch Cardiograph
Amiscus Separator
Precision Xtra Blood Glucose Meter
Femoral Guide CathetersLSF Collarless Porous CoatedMuta Guide CathetersRadial Guide Catheters
TSRH Silo Spinal System - Sagittal Adjusting Screw for Rod - TI
Guidewire
Access TPO Antibody Calibrator
Access Ultrasensitive Insulin Assay
Colleague 3 Volumetric Infusion PumpColleague Guardian Enhanced 3 CXE ColorFrench Colleague 3 CXE Volimetric Pump
Vessel Cannulae
Desktop Pro versions 4.2 (rel 4.1), 5.0, 5.1 , 6.0
Elekta Synergy XVI
Unicel DXL800 access immunoassay system
Unicel DXL Immunoassay system
5C Cell Control
Access Immunoassay Myoglobin Assay
Apexpro/Apexpro CH Telemetry System
Cal Packs Used In ABL 77 (PART 944-069)
Proteus XR/d
Actiwatch-64, series V96
STFR Control Set
Volusion E8 Ultrasound System
Phaseal Infusion Adapter C100
A) Sprint Fidelis Steriod Eluting Trip. Vent. Lead W/RV. Defib. Coil ElectrodeB) Sprint Fidelis Steroid Eluting Quad. Vent. Lead W
Angiomat Illumena - Auxiliary Console
Bartels Viral Respiratory Screening & Identification Kit
Aeroset System - Instrument Class 2
Durom Hip Resurfacing System - Acetabular Component
Wellcogen N Meningitidis B/E Coli K
BD Cellquest Prosoftware
Nemio SSA-550A
Aplio XG (SSA-790A)
Terumo Advanced Perfusion System 1
Access System - Testosterone Assay
Immunoassay Analyzers
Bone File
Aeroset System-Creatine Kinase Assay
A) Soft Tip FrazierB) Frazier Suction InstrumentC) Poole Suction Instrument
Accelerator APS System Input/Output Module (IOM)
3M ESPE Unitek Stainless Steel Crowns
Duoject Easy-Prep System
A) Mevatron Linear AcceleratorsB) Oncor Expression Digital Linear Accelerator C) Oncor Impression IMRT Plus
Nexgen Complete Knee Solution CR-Flex Gender Solution Female (GSF) Femoral Provisional, Size F
Various Devices and Accessories
A) Mevatron Linear AcceleratorsB) Oncor Impression
Clinitest HCG
Dale Tracheostomy Tube Holder
A) Coherence Oncologist RTB) Oncologist ViewerC) Coherence Therapist 2.0
A) Soletra Quadripolar Multi-Programmable NeurostimulatorB) Kinetra Neurostimulator Pulse Generator
Trilogy Cluster Hole Shell, Non Coated
Ambu Peep 10 reusable valves (Update/ Mise à jour)
Intellivue Patient Monitor System - Multi Measurement Server
P3200 Versacare Bed
i-STAT Cartridges
A) Definium 8000 TableB) Revolution XR/d Table
BD Multiset Software
High Pure System Viral Nucleic Acid Kit
A) AW 4.2B) AW VolumeshareC) AW Volumeshare 2
Micotainer Brand Lancet
Liquichek Urine Tox Control (Levels S2)
Esprit Ventilator (Backlight Inverter)
Precicontrol Universal
Septoplasty Pack
A) BBL Fluid Thioglycollate MediumB) BBL Trypticase Soy Broth
Welch Allyn AED 10 Defibrillator
Mirror Defogger / Solution
Atlas PTA Balloon Dilation Catheter
A) AxSYM GentamicinB) TDx/TDxFLx Gentamicin
Asteion M/S 4, Asteion S/S
A) Elefant Suction-Irrigation Device B) Elefant suction-irrig. with connect tub
A) C60A2 Dual Chamber Rate Responsive             Pacemaker (DDDR)B) T60DR Dual Chamber Rate Responsive         Pacema
Carendo Hygiene Chair
M3170 Intellivue Patient Link
Sigma 8002 Dual Channel Infusion Pump
A) PFC Sigma Knee System - ALL PolyethlenB) PFC Sigma Knee System - PS RP BearingC) PFC Sigma Knee System - Stabilized TI
Pump Tubes For ABL800 Series
Endopath 5MM Curved Dissector With Mono
Genesis II femoral sets
Ultrasonic Air Sensor
Instrument Manager Software
Integrated Centrifugal System Control Unit
Thoratec IVAD Pump
Cell-Dyn 1700 System-Instrument
A) Burr-Coarse Diamond BallB) Burr-Coarse Diamond DrumC) Burr-Diamond BallD) Burr-Diamond DiscE) Burr-Diamond Flame
Cytomics FC 500 Flow Cytometer
Action forceps with insulated shafts
A) Aquilion 32B) Aquilion 64
A) Cytomics FC 500 Flow CytometerB) Cytomics FC 500 MPL
Sychron CX Systems salicylate reagent
Coulter LH Slidestaner/Slidemaker
A) Cytomics FC 500 Flow CytometerB) Cytomics FC 500 MPL
A) HemosIL RecombiPlasTinB) Hemoliance RecombiPlasTin
Surgical Video Cart
Oasis Power Wheelchair
A) CentralgardB) Drain-FixC) EPI-Fix
Magnetom Harmony
Sultan Brand Mirror Defogger
Ambu Peep 10 reusable valves (Update 2 / Mise à jour 2)
Mirror Defogger / Solution (Update / Mise à jour)
A) Tripolar Cutting ForcepsB) Tripolar Ultra Forceps
Masimo Rad 9 Pulse Oximeter
Pressureguard Easy Air Mattress
A) COBE Spectra Tubing SetB) COBE Trima Tubing Sets
TD-Synergy Software (TD-SYN-01)
A) Sterrad 100 S SterilizerB) Sterrad 50 SterilizerC) Sterrad NX Sterilizer
Liquichek Urine Tox Control (Level S2)(Update/Mise à jour)
A) Microcuff Pediatric Curved ET - PVCB) Microcuff Pediatric ET - PVC
Terumo Advanced Perfusion System 1
A) Terumo Advanced Perfusion System 1B) Central Control Monitor
Terumo Advanced Perfusion System 1
A) Terumo Advanced Perfusion System - Roller PumpB) Terumo Advanced Perfusion System - Centrifugal Control Unit
Terumo Advanced Perfusion System - Modules
Versys Hip System - Advocate Cemented Femoral Stem
A) Paradigm - Insulin Infusion PumpB) Paradigm 552 Insulin PumpC) Paradigm 722 Insulin PumpD) Paradigm Insulin Infusion P
Alyx Component Colleciton System
Terumo Advanced Perfusion System 1
BD Integra Insulin Syringe
BD Procount Progenitor Cell
BD Sensi-Disc Ticarcillin
Gambro AK-95
Prismaflex Hemodialysis Unit
A) Sarns Modular Perfusion System 9000B) Sarns Centrifugal SystemC) Sarns Modular Perfusion System 8000
DSL-5600 Active Insulin-Like GF-I
Brilliance CT 40 Channel
BD Difco Shigella Antiserum Poly A1
Contak Renewal 4 crt-d
Sealex Extra Root Canal Sealer
A) BacT/Alert 3DB) BacT/Alert 3D 240C) BacT/Alert 3D Combi
Kodak Directview DR3000 System 80KW Generator
A) Anorectal Tip with SheathB) Anorectal Tip
Liquid Assated Multiqual 1,2,3
Active DHEA EIA, 96 Wells
Access Free T3 Assay
A) Cytomics FC 500 CXPB) Cytomics FC 500 MPL
A) Disposable Administration Sets (D/DI)B) Disposable Irrigating Sets (IR Series)
Instatrak 3500 System
A) Lightspeed Pro 16B) Lightspeed VCT CT SystemC) Lightspeed VCT 32 Slice
A) Lightspeed VCTB) Lightspeed VCT Select
BacT/View Software
Vitros ECI Immunodiagnostic System - HBSAG Reagent Pack
Medfusion 3500 Syringe Infusion Pump
Isite Pacs
Architect System - Estradiol Reagent
Suture Passer
A) Mini 6600 Digital Mobile C-ArmB) Uroview 2800 Digital Imaging SystemC) OEC Miniview 6800D) OEC 9800 Plus Mobile Ima
A) Brilliance Computed Tomography SystemB) Brilliance Computed Tomography System
ASR Acetabular Cup System
A) 25 Gauge High-Speed CutterB) High Speed Posterior Vitrectomy Pack
Cardiac Troponin-I Flex Reagent Cartrid
Radiance
A) Mobilett XPB) Mobilett XP
Lithoskop
Clearview Simplify D-Domer
A) Impax DS3000B) Impax OT3000 Orthopaedic Workstation
Puritan Bennett 840 Ventilator
End Cap
A) Smart BoxB) Smart BoxC) Smart BoxD) Smart BoxE) Smart Box
Advia 1650 Clinical Chemistry System - Benzodiazepene Assay
Gatekeeper Reflux Repair System
Matrix 2 Firm 360
A) Synchron LX20 ProB) Synchron LX20 System AnalyserC) Symchron LXI725D) Unicel DXC 600I AnalyserE) Unicel DXC 800
OEC Flexiview 8800
OEC Minview 6800
OEC Uroview 2800
Axsym System - TOXO IGG
Fluid Warming System
Defibtech DDU-100 Series AED (Lifeline)
Architect System-Stat Troponin-I Assay
Carotid Wallstent System
Starclose Vascular Closure System
Fluid Warming System
Prismaflex Cont.Renal Replacement System
Prismaflex Cont.Renal Replacement System
ABG Kit
Padpro Adult Radiotranslucent Pad
Flexcath Steerable Sheath
Infinia Gamma Camera
A) Coulter LH 750 Hematology analyserB) Coulter LH 780 Hematology analyser
Surgical Duotome Sidelite Fibre for Holmiums
Synchromed II - Programmable Pump
U-Clip - Removal Tool
VYSIS LSI ATM/P53 and D13S319/CEP 12/13Q34 Probes.
LADAR6000TM Excimer Laser
IMHS Lag Screw
Cobas Integra-Digoxin
Infant Nasal CPAP System
BD Vacutainer Safety Lok Blood Coll
Fusion Pacing Software Revision 1.0
BD Mini Blade
A) Radiolucent Drill Guide DropB) Radiolucent Drill Guide DropC) Radiolucent Drill Guide DropD) Radiolucent Drill Guide Drop
Prismaflex Cont. Renal Replacement Sys.
Gambro Cartridge Blood Tubing 003409410
Infusion Pump, O.R., Syringe
A) Colleague 3 Volumetric Infusion Pump B) Colleague Guardian 3 CXE Color PumpC) Colleague Volumetric Infusion Pump
Aplio XV Ultrasound System
Nuclisens Easymag Disposables
HL 30 Perfusion System
A) Linear AcceleratorsB) Digital Linear AcceleratorC) Oncor Impression IMRT
Lithoskop
X Systems Methotrexate II Assay
See 33-01
A) Contak Renewal 3 RF CRT-DB) Contak Renewal 3 RF HE CRT-DC) Contak Renewal 4 CRT-DD) Contak Renewal 4 HE CRT-DE) V
A) Matrix 2 Firm 2DB) Matrix 2 Firm 360C) Matrix 2 Soft 2D SRD) Matrix 2 Soft 360 SRE) Matrix 2 Soft SRF) Matrix 2 Standard S
Heartstart FR2+ Automated Defibrillator
Proximate Hemorrhoidal Circular Stapler
A) CADD Adminstration SetsB) CADD Prizm Adminstration Set
Checkcells (Pooled cells)
Molt Periosteal Elevator #9
ACT 5Diff Series Hemetology Analyzer
Paragon CZE 2000 Electrophoresis System
4C Plus Cell Control
Infant Nasal Cannula
Voxel Q Field Upgrade to ACQSIM
Streck CD-CHEX CD34 Assay
Maxi Move Patient Lift
Guardian Hemostasis Valve FH100
BEP2000 ADV System Release Kit 1.23.3
TEC 6 Plus Desflurane Vaporizer
Revolution XR/D
OEC 9800
OEC Instatrak 3500
A) Innova 2100 IQB) Innova 4100 IQ
OEC Instatrak 3500
OEC Instatrak 3500
Reflection Cement Acetabular AllPolyCup
CIC Pro Central Station
PET Eliminator Balloon Dilator
Blood Pack Unit with CPD
3.5mm 90-S Serfas Energy Suction Probe
AMG MEDPRO Lubricating Gel
Paracorporeal Ventricular Assist Device
A) Custom Sterile Cardiovascular PackB) Custom Sterile Cardiovascular Pack
Reacher Bar with Small Carabiner
Axsym System - Ultrasensitive HTSH II Assay
Cobas Integra System Valproic Acid
Acticlot dPT
A) Sychron LX20 ProB) Sychron LX20 System AnalyzerC) Synchron LXI 725D) Unical DXC 600E) Unical DXC 600I AnalyzerF) Unice
BD microtainer tube w/glycolytic inhibitors
A) Coulter LH 500 Hematology AnalyzerB) Coulter LH 750 Hematology AnalyzerC) Coulter LH 780 Hematology AnalyzerD) Gen
OEC Uroview 2800
Infant Nasal Cannula
CAB + 5% Sheep Blood
Tood Hewitt Broth w/ Gentamycin and NA
Assayed Bovine Serum
Ceegraph Netlink Traveler
Protaper Obturators
A) Rita Starburst Electrosurgical DeviceB) Rita Starburst Semiflex Electro. DeviceC) Rita Starburst XL Electro. Device
Ultrasite Horizon Pump IV Set
Vitros ECI Immunodiagnostic system - Troponin I Reagent Pack
Conmed Linvatec Medical Devices packaged within certain Peel Pouch sterile Packages
BHIA + Vancomycin
A) One Touch Basic Owner's BookletB) One Touch Profile Owner's Booklet
HD11 Ultrasound System
A) S8 Autoset Vantage Flow Generator CPAPB) S8 Compact Flow Generator CPAP SystemC) S8 Escape Flow Generator CPAP Sy
Olympus AU Immunochemistry System - Triglyceride Assay
Sta System - Liatest Free Protein S
Elecsys Cortisol, Cortisol Test Kit
A) Achieva 1.5T MRI System, Main UnitB) Gyroscan Magnetic System ACS-NTC) Gyroscan Magnetic System T10-NTD) Intera 3.
A) Axsym System - Total B-HCG AssayB) IMX System - Beta-HCG Reagent
Elecsys Free T4 Cat# 11731297122
Elecsys Parathyroid Hormone Cat# 11972103122
A) Axsym CMV IGM 2.0 ReagentB) Axsym Rubella IGG ReagentC) Axsym System - CA-125 AssayD) Axsym System - Folate Assay
Gelose MRSA Select REF63747, LOT7C1025
Patrol Pump Set with Piercing Pin
External Dental Implant System - Complete OP & OS Surgical Kit
External Dental Implant System
ABL80 Flex Analyzer
A) Rascal Power ChairB) Turnabout Power Chair
A) FCR Velocity UB) Fujifilm DR Velocity UFP
BD Facsdiva software
Jostra Heater Cooler Unit 30 System
C. Cam Imaging System
Axsym System - Digoxin III Assay
Sienet Magicstore
Architect System Urine/CSF Protein Assay
Allura XPER FD10
Devilbiss pd 1000a and 535d oxygen cylinders
A) Hoy-advance-eB) Hoy-advance-e
Metronidazole 10 ug disc
Legendair Ventilator Single/Double Bran
FP1000 CeII Preparation System
A) QuickieB) QuickieC) Quickie
Flow Count Fluorospheres
Cytomics FC 500 Flow Cytometer
LRGE Electrode Deflectables-Quadrapolar
BD Multivisc 2.5% Viscoadaptive solution
Accelerator Aps System
Bone File
Abbott Real Time HCV Assay
Weak D Cells
External Dental Implant System
Architect Free T3 Reagent
A) Symbia-S-SeriesB) Symbia-T-Series
Synchron Systems Gentamicin reagent
A) Clearlink Paclitaxel IV Admin. SetB) Interlink Paclitaxel IV Admin. Set
Correction to this recall previously posted on 2006-05-29. / Correction apportée à ce rappel affiché le 29 mai 2006. Conta
Software Releases 2.1.0 - 4.3.0
High Energy Clinac Linear Accelerator
A) VARiS Vision v6.2 or higherB) VARiS Vision v6.2 or higher
P3207A01&02 Patient Pendants
Panocell-16 16 x 3 ml
C-Series Clinac Hand Pendants
A) OsteoGraf/D-300 & OsteoGraf/D-700B) OsteoGraf/LD-300C) Osteograf/N-300D) OsteoGraf/N-700E) PepGen P-15 Putty
CAL 2 Solution
Roche Elecsys Folate
SEBIA Hydragel 15 Hemaglobin (E)
Nico model 7300 Cardiopulmonary System
Microalbumin Multi-Calibrator Set
Conveen Urine Bag, 1500ml, 90cm Tube
TempBond Clear
A) Colleague 3 Volumetric Infusion PumpB) Colleague 3 Volumetric Infusion Pump
Benchmark Automated Slide Stainer
Periowave Disinfection Syst. Footswitch
Periowave Disinfection System Handpiece
Lorenz Pectus Support Bar, 14in
BD BBL Staphyloslide Latex Test
A) BenchmarkB) Benchmark LTC) Benchmark XTD) Discovery XT
BD Procount Progenitor Cell Enumeration
Lactosorb Suspension Screw
Mars Treatment Kit
4D Integrated Treatment Console, 1.4g
A) CSI Daily WearB) CSI Flexible WearC) CSI Toric
Enpulse Dual Chamber Rate Responsive Pacemaker
Emit 2000 Phenobarbital
ICCG Long Term Care Beds
Kinetra Neurostimulator Pulse Generator and Accessory Kit
GENESIS II Nonporous Tibial Punch
Medisorb
Advia 1650 Clinical Chemistry System-Valporic Acid Assay
LifePack 20 Defribrillator
Reacher for Transportable Ceiling Lift
Gambro Prisma Sets (M100, M60, HF1000) CORRECTION TO THIS RECALL PREVIOUSLY POSTED ON FEBRUARY 6, 2
Slidex Pneumo-Kit
Conmed Electrosurgery System 5000
Thumper Mechanical CPR Device
Vitros DTt System Glu slides (glucose)
Clinical Chemistry Magnesium
CA 15-3 Controls
8.5mm Bivona Adult TTS Trachestomy Tube
Fructosamine Control Level 1
QuickStick hCG Urine Pregnancy Test
TLC-II Portable VAD Driver
OneTouch SureStep Test Strips
Kwiktrak Fix Gate
Architect CBT Kits
A) Hem-O-Lok Automatic Ligating Clip Applier(with clips) - EndoscopicB) Hem-O-Lok MLX Non-Absorbable Polymer Ligating Cli
Paceart System Software
A) 5in Wheels KitsB) Guardian Walkers
Abdominal Pads
Coulter LH750 Series System
Legion Offset Coupler Trials
A) Sher-i-Bronch Endobronchial Tube, 37FrB) Sheridan Preformed Cuffed Nasal Endo.C) sheridan Preformed Cuffed Oral Endo.
Micrus Guidewire Insertion Device
GE Centricity Triwin Laboratory Information System -Microbiology Module
Centricity Triwin Laboratory Inf.
Enpulse Dual Chamber Rate Responsive Pacemaker Updated recall previously posted on 2006-10-16. / Mise à jour de ce
Profix hall 3/4 fanned Sawblade
Leksell Gamma Knife C Version 1.2/4C
Immulite 2000 System-Analyzer (Class 2)
A) Lifepak 12 Defibrillator/MonitorB) Lifepak 20 Defibrillator
A) Amplatzer Delivery SystemB) Amplatzer Exchange SystemC) Amplatzer Torqvue Delivery SystemD) Amplatzer Torqvue DS /
CR NX Modality Workstation
A) Poly Tibial Component ImpactorB) Tibial Tray ImpactorC) Femoral ImpactorD) Femoral Inserter/Impactor
Kjaerulff Mini Lift Stand Aid
Panocell-16, 16 X 3ML
Arjo Minstrel Lift with Scale
Vitros Chemistry Products System - Lipa Slides (Lipase)
Fabius GS
A) Disposable Hand Held DissectorsB) Disposable Hand Held GraspersC) Detachatip Multi-Use Laparoscopic Inst.
Laminated Wooden Crutches
A) HL20/HL30 Perfusion SystemB) HL20/HL30 Perfusion System
A) Syngo ImagingB) Syngo Imaging
Magicview 300/Sienet Sky
Cosmos IDM/OPM
CELL-DYN Sapphire
Narkomed 6000 Series Anesthesia Machine
Lactosorb Full Size Container
Opart MRI System
Aplio XV Ultrasound System
ITHA52 Certain EP Healing Abutment
Aquillion 16-Slice System
Labpro Software Version 1.55,1.91, 2.01
A) Aquillion 32/64B) Aquillion 32/64
A) Aquilion and Aquilion CFX EditionB) Aquilion and Aquilion CFX Edition
Coaguchek PT Strips
Flow Dependent Micro-Catheter
A) Labpro Software Version 1.55,1.91, 2.01B) Labpro Software Version 1.55,1.91, 2.01
Nico Non-Invasive Cardiac Monitor
Sheridan Performed Cuffed Nasal Tube
A) OT SystemsB) OT SystemsC) OT SystemsD) OT SystemsE) OT SystemsF) Siregraph System and AccessoriesG) Siregraph D3 Ba
Latitude Elbow Prosthesis Radial Head
OneTouch SureStep Test Strips Updated recall previously posted on 2006-10-30. / Mise à jour de ce retrait affiché le 200
Clinical Chemistry Magnesium
A) Twist DrillsB) Twist DrillsC) Twist Drills
Leksell Gamma Knife
A) BacT/ALERT Classic SystemB) BacT/ALERT 3D SystemsC) BacT/ALERT 3D 60 SystemsD) BacT/ALERT 3D Combo Systems
Sonoline G40
Magnetom Trio
Lithosk OP
Modularis URO
Access System - Thyroglobulin assay
Propaq LT Vital Signs Monitor
Cell-Dyn Sapphire
Dehydroepiandrosterone (DHEA) RIA
Normothermic IV Fluid Administration Set
A) Cell-Dyn 1800B) Cell-Dyn 22 Control & Calibrators
N Latex HCY
NOW Legionella Urinary Antigen Kit
Stem-Trol Control Cells
Quickstick HCG Pregnancy Test Kit
Architect FSH Calibrator
Calstrux
Aquilion CT Scanner
Oral Dispensers
Brilliance CT Big Bore System
Eyelogic System
Optivantage Dual Head Injectors
Power Pro Ambulance Cot
A) Soft Tip FrazierB) Frazier Surgical Suction Instrument C) Poole Suction Instrument
Clinical Chemistry Phenobarbital
Cell-Dyn 22 Calibrator
REMstar Heated Humidifier
HL30 Perfusion System
Welch Allyn PIC 50
Bremer Halo Traction System
IE33 Diagnostic Ultrasound Transducer
Gemini GXL 6/10/16 Slice Pet/CT System
Centrifuge Bowl Comp. Of the UVAR XTS
Dade Cardiac XL
Laminated Wooded Crutches
Onetouch Ultrasmart Blood Glucose Meter
DT Post
Swabette
Cord Clamp Clipper
A) ABG Kit, Aspirator with Alcohol PackB) ABG Kit, Aspirator with Ice Pack
Digital Fluorography System
D-10 Haemoglobin Testing System-Dual Program
Damon 3 Bracket (High Torque Version)
XiVE 3.0 Dental Implant System
BD Procount Progenitor Cell Enum.Kit
A) Precise Desktop(R4.2 and R5.0 MLC Head)B) Precise Desktop(R4.2, R5.0 MLC Head)
Elekta Desktop Pro 6.0/6.1
A) Flo-Gard 6201 Volumetric Infusion PumpB) Flo-Gard 6301 Volumetric Infusion Pump
Jostra Heater-Cooler Unit 30 System
HL 30 Perfusion System
ACS Rotating Hemostatic Valve
A) Linear AcceleratorsB) Linear Accelerators
OEC 9900
Liquichek Cardiac Markers Control LT
A) Amplicor CT Detection KitB) Cobas Amplicor CT Test
A) DT PostB) DT Quartz
Architect LH Reagents
Acrobat Vacuum Stabilizer
Hemashield Woven Double Velour Fabric
Lithoskop
Panacryl Suture
A) Compact ATS KitB) Electa Wash SetC) Electa Wash Set
A) Alaris SE PumpB) Alaris SE Pump
Isolette C2000 Incubators
A) Continu-Flo Sets With Check ValveB) Continu-Flo Sets With Check Valve
IV Pole
IMPAX 5.2 System
OptiBond Solo Plus Self-Etch Adhesive
OEC Mini 6800 C-ARM
Aisys Carestation
AW 4.2
A) EP-4TM Computerized StimulatorB) EP-4TM Computerized Stimulator
A) Onetouch Surestep Blood Glucose MeterB) Surestep Hospital Blood Glucose Meter
A) Renal Software Suite V.3.1 HD ModuleB) Renalsoft Observational Study V.2.0C) Renalsoft Observational Study V.2.0D) Rena
Detachatip Multi-Use Laparoscopic
ProFile GT File
Rigiflex II Achalasia Balloon Dilator
Total Knee External Limb Component, KNE
A) ACCU-CHEK Ultraflex Infustion SetB) ACCU-CHEK Ultraflex II
A) Colleague 3 Volumetric Infusion PumpB) Colleague Volumetric Infusion Pump
A) Coulter Clone CD3 (IgG1)-FITCB) Coulter Clone MY4-FITCC) Coulter Clone T11-FITCD) Coulter Clone T8-FITCE) Coulter Clone
A) Midland Deluxe Mat PlatformB) Mat Platform with Adjustable BackrestC) Space-Saver Mat PlatformD) Valueline Mat Platfor
A) Synchron LX 20, LX20Pro Software V4.5B) Synchron LXi 725 Software Ver. 4.5C) UniCel DxC 600/800 Software Ver. 1.0D) Un
ADVIA 1650 Clinical Chemistry System
Agilis Steerable Introducer
Excelsior Syringe Pump
Fuji VIII Shade A2
Handpieces, Bur Guards, Attachments
Rapidlab 1265 System
Synchron Systems Vancomycin Reagent
A) Stratus CS Testpak and DipakB) Stratus CS Testpak and DipakC) Stratus CS Testpak and DipakD) Stratus CS Testpak and Dipak
A) Titanium Low Profile Implanted PortB) Hickman Subcutaneous PortC) Chronoflex Polyurethane CatheterD) M.R.I Dual Impl
Ecat Art Pet System
Gambro Cartridge Blood Sets
Heavy Duty Portable Suction Unit
Medi-Temp III Blood & Fluid Warmer
Motor Option
Sidexis XG 1.33-1.36 and 1.4-1.43
System 1000 Dialysate Delivery System
Tecnis Foldable Intraocular Lenses
A) 3D Ceiling StandB) 3D Ceiling StandC) 3D Ceiling Stand
A) 3D Ceiling StandB) 3D Ceiling StandC) 3D Ceiling Stand
A) Dual Heating Accessory PackB) Adult Breathing Circuits
A) Flowmeters/RegulatorsB) Flowmeters/RegulatorsC) Flowmeters/Regulators
A) Gammaplan Scanner InterfaceB) Leksell Surgiplan
A) Somatom SensationB) Somatom Sensation
Accu-Chek Advantage Test Strip
AS50 Infusion Pump
Burrs - Stainless Steel
CRS Master Software Accessory for MEL 80 Laser Ophthalmic Diagnostic Product
CXP Software Versions 2.0 & 2.1
Dimension Cocaine Flex
Dimension MMB Flex Reagent
EZ Bent Tip Sheath
Ferno 65EXL Scoop Stretcher
Hoya Conbio Medlite C6 Laser
Leksell Stereotatic System
Lifepak 500 Hard-Shell Case
Mac 5000 Trolley
Microlab AT, AT+, AT+2
Optibond Solo Plus
Profile GT File
X-Systems Barbiturates II Calibrators
Genesis II Cruciate Ret.Nonporous Femor
A) Ranger Highflow Blood/Fluid Warming SetB) Ranger Highflow Blood/Fluid Warming SetC) Ranger Highflow Blood/Fluid War
Gammamed Plus
Disposable 3-Pronged Looped Forceps
Genesis II MB Knee Instruments
Newton IQ Dialysis Cycler Set
A) Obtryx Transoburator Mid-Urethral SlingB) Obtryx Transoburator Mid-Urethral Sling
A) Stryker PainPump 1B) Stryker PainPump 1 and Painpump 1.5
SE Graft Tensioner Breakaway Pins
A) Atlantis SR Intravascular CathetersB) Intravascular Ultrasound Imaging System
Coulter LH500 Hematology Analyzer
A) Innova 2000B) Innova 4100
Access Immunoassay System CEA
A) Sherpa Balanced Guide CatheterB) Zuma Coronary Guiding CatheterC) Launcher Guide Catheter
ImmunoCAP Specific IgA Conjugate
Vicryl Absorable Suture
Contak renewal 4 CRT-D
A) Vac Abdominal Dressing
A) Ranger HighFlow Blood/Fluid Warming Set
Transactive Plus Patient Lift
A) Factor 2B) Factor 9C) Group AD) Group B, Factors1/4/12/27E) Group D1F) Group EG) Group E2H) Group E3I ) Group E4J) Gr
BD FAVS 7-Color Setup Beads Kit
ADVIA 1650 Chemistry System
ADVIA 2120 Hematology System
AW 4.2
Ampltzer Septal Occluder
Fuji Synaps Image & IMS Software
A) Slidex Strepto BB) Slidex Strepto Kit
Slidex Rota-Kit 2
Truguide Coaxial Biopsy Needle
Synchromed Physician Programmer
Quantity Control
Galileo Immuno Haematology System
ILAB Cart System
A) Chemosite System-Introducer KitsB) Chemosite System-Ports
I Pump Pain Management System
AGFA DX-S
Radionics Cool-Tip RF System
A) KyphX Elevate Inflatable Bone TampB) KyphX Exact Inflatable Bone Tamp
A) Onetouch Surestep Blood Glucose MeterB) Surestep Hospital Blood Glucose Meter
A) Ballard R2 Multifunction ElectrodesB) Ballard R2 Multifunction Electrodes
Stonetome Stone Removal Device
Synthes Resorbable Cortex Screw
Cell-Dyn 4000 Diluent/Sheath
iSsite PACS
XSYSTEMS Barbiturates II U Controls
A) MD3-SystemB) Multidiagnost 4
Brilliance CT Big Bore System, Main Unit
Architect B12 Reagent
Microline Pentax Renew II Endo-Cut
 Easyvision Workstations
A) Axiom Artis B) Axiom Artis C) Axiom Artis D) Axiom Artis E) Axiom Artis F) Axiom Artis
Kavo Dental Chair - Promatic
A) Insufflator Tube SetB) High Flow Insufflator Tube Set
Transducer Kits/Custom Transducer Kits
A) Gambro Integra Dialysis SystemB) Gambro Phoenix Dialysis System
i-STAT EG7+ Cartridge
Bar Electrodes W/Strap
BioPure MTAD
Krupin Eye Valve
6060 Set With Pre-Attached 250ml Bag
A) Axiom ArtisB) Axiom ArtisC) Axiom Artis
A) Axiom ArtisB) Axiom ArtisC) Axiom ArtisD) Axiom ArtisE) Axiom ArtisF) Axiom ArtisG) Axiom Artis
A) Somatom SensationB) Somatom Sensation
Allura XPER FD 10
ARCHITECT i2000 and i2000SR Systems
Auto Syringe Infusion Pump
Go Bed Plus FL25E
Hemashield WDV 4 Branch Grafts
IMx STAT CK-MB Mode 1 Calibrators
Integra (Opto-Triac on Integra)
M/L Taper Offset Rasp Handle
Modified Alsever's Solution Lots 10&11
Strykeflow 2 Pump and Handpiece
System 1000 Dialysate Delivery System (TINA)
Urine Protein Calibrator (UCAL)
Vascular Access Catheters
Zero Tip Stone Retrieval Basket
A) Arena SPP Hemodialysis Delivery SystemB) Arena SPX Hemodialysis Delivery System
A) Ligasure Atlas LS1120B) Ligasure Atlas LS1100
A) MammoreportB) Mammoreport
A) Model 6060 Homerun Multi-Therapy VIPB) Model 6060 Homerun Multi-Therapy VIP
AGFA Cronex 10T
Architect STAT Troponin-I Reagent
Architect System Software, Version 2.11
AxSYM LH Controls
Bact/View System
BD Gazpak Systems
BD Phoenix Nephlometer Calibration Tube
Burs Sterile Single-Use in Blisters
Calpack for ABL77 Blood Gas System
CoolGard 3000 Temperature Reg. System
Core Motor Controller
Coulter A-T Diff & Diff2 Hemat Analyzer
GRAB'N' Go Oxygen Regulator
Hamilton Microlab AT, AT+ ET AT+2
Insignia I Entra SSI
Intra-Compartmental Pressure Monitor
Lifepak 12 Cable and Paddles
Lifepak 500 AED
Lifepak CR Plus
Liquicheck Hematology Control (C)/L,N,H
Multiconstituent Calibrator
Ortho Summit Sample Handling System
Pediatric Underbody Blanket
Proxis Embolic Protection System (RE)
ReadySet Hemodialysis Blood Tubing Sets
Sternum Saw Collet Nut 5059-09
T2 Recon Lag Screws
A) ADC Compact Digit.-Software/Tool for NTB) ADC Solo Digitizer.-Software/Tool for NT
A) ADC Solo Digitizer for NT SystemB) ADC Solo Digitizer for UNIX System
A) Magnetom AvantoB) Magnetom Espree
Cosmos IPW
Cosmos IPW
Coulter LH700 Series System
Cytomics FC 500MPL Flow Sys w MXP Softw
FHC Microtargeting Drive Motor Options
Ladarvision 4000 Excimer Laser System
Lifepak 20 Defibrillator/Monitor
Liquid Assayed Multiqual 1,2,3
Medley PCA Module
Neovisc Sterile Sodium Hynluronate Inj.
Reposable Metzenbaum Curved Scissor Blades
Sterrad 100S Sterilizers
Synchron Systems Ammonia (AMM) Reagent
Synchron Systems CRPH Reagent, high sen
VARiS Sys 6.5 & higher to v.7.3.10 SP2
Zilver Biliary Stent
A) BD Latitude BGMB) BD Logic BGMC) The Link BGM
A) Infusion Pump, Patient Controlled APIIB) Infusion Pump Patient Controlled AmbulatC) IPump Pain Management System
Alyx Red Kit
Bard Composix Kugel Mesh X-Large Patch
Cook Osteo-Site Vertebroplasty Kit
Ear Candles
Elecsys Troponin T
Endoscopic Cytology Specimen Brushes
Erigo
Fusion Omnio Glo-Tip ERCP Catheter
Gambro Prisma Sets (M100)
MX441B Blood Pressure Manometers
Proceed Surgical Mesh
Vitros Immunodiagnostic HBsAg Kit
Zero Tip Stone Retrieval Basket
A) Apolipoprotein A1 assayB) Immunoglobulin MC) Prealbumin Assay
A) CAPD Disconnect CapsB) CAPD Disconnect Caps
A) Catheter Extension SetB) Huber Needle Extension SetC) IV Extension SetD) IV Extension SetE) Pain Management Set
A) Coulter LH700 Series SystemB) GEN*S Analyzer
A) Envision+System/HRP Mouse (AEC+)B) Envision+System/Hrp Mouse (DAB+)C) Envision+System/HRP Rabbit (AEC+)D) Envisi
ABL5 Blood Gas Analyser
Allon 2001
BD Bard-Parker Protected Blades
Coulter 5C Cell Control
Cytomic FC 500 with CXP Software
D826 Accessory Kit
Dimension RCRP Flex Reagent
Extravasation Detection Accessory (EDA)
Immulite 2000 Testosterone
Intergris Cardiology Imaging System
M3717A Heartstart Defibrillator Pads
Microlab AT, AT+, AT+2
Samaritan Automated External Defibrilla
Savary-Gilliard Dilator
Thermal DOT Matrix Printer
Wallace Oocyte Recovery Set
A) BD Critiflo Flush DeviceB) BD Critiflo Flush Device
A) Colleague 3 Volumetric Infusion PumpB) Colleague Volumetric Infusion Pump
A) DST-XL Nuclear CameraB) DST Nuclear Camera System
Access system DHEA-S Assay
Act 5diff Series Hematology Analyzer
BD BBL Oxacillin Screen Agar
BEP 2000 and BEP 2000 Advance
GEM Premier 3000
Logic 5 Ultrasound System
Vapotherm 2000i
Cell-Dyn 3700 Systems
ECG 5 Lead, IEC, Cable
Flextome Cutting Balloon
Modified Alserver's Solution
MP-28 Sofport IOL Inserter
Omron 3-Way Instant Thermometer
Onetouch Basic Blood Glucose
Pathfinder Herpes Simplex Virus
Stainless Steel Greenfield Vena Cava
StrykeFlow 2 Pump and Handpiece
A) Banana Peel SheathB) Vaxcel Dialysis CatheterC) Vaxcel Implantable Vascular Access SystemD) Vaxcel Implantable Vascular
A) Basic IV Solution Set*******************************B) Basic IV Solution SetC) Blood IV Solution SetD) Catheter Exten
A) Brillaince 40 Tomography SystemB) Brilliance Computer Tomography SystemC) Gemini SystemD) CT Vision MX8000(D)E) CT
A) Catheter Extention SetsB) Continu-Flo IV Solution setC) IV Extension Set
A) Colleague 3 Volumetric Infusion PumpB) Colleague Volumetric Infusion Pump
A) Colleague Volumetric Infusion PumpB) Colleague Volumetric Infusion Pump
A) Huber Needle Extension SetB) IV Extension SetC) Pain Management Solution Set
A) Infusion Pump, Patient Controlled APII B) I-Pump Pain Management System
A) IV Solution SetB) IV Solution SetC) IV Solution Set****************D) IV Solution SetE) Solution SetF) Solution Set G) Solu
A) Lifeshield Hema Y-Type Blood PlumsetB) Lifeshield Hema Y-Type Blood Plumset
A) Magnetom Avanto SystemB) Magnetom Espree
A) Magnetom Avanto SystemB) Magnetom Symphony MRI System
A) Synchron Systems LX20B) LXi725C) LX20PRO
Abbott Testpack + Plus HCG Combo
Absolok Extra Ligating Clip Cartidges
Aquify Long Lasting Comfort Drops
Architect C8000 Processing Module
Architect Folate Reagent
B+ Basic Amino Acid Supplement
Bard Uroforce Balloon Dilation Catheter
BD Difco Niacin Assay Medium
BD Safety Glide Syringe
Berichrom ATIII Kit
Birthnet OB Data Management System
Celite ACT
Cell-Dyn 22 Control
Cell-Dyn 4000 System
Cell-Dyn 4000 System
Clinical Chemistry Bilirubin Calibrator
Control Plasma P 10x1ML
Cytomics FC 500 MPL
Diamed AG ID-Pagia Heparin/PF4 Test
Dimension RCRP Flex Reagent
Dolomite Soprano
Endoclamp Aortic Catheter
Heartstart MRX Defibrillator / Monitor
HercepTest Visualization Reagent
Hovermatt Patient Transfer Solution
Invacare HMV 220 Scooter
Kodak Flexible Phosphor Screen
Lifecare PC 3 Infusion System
Liquid Assay Multiqual 1,2,3
Liquid Unassayed Multiqual 1,2,3
MDA System - Verical Set
Methotrexate Assay
MX441B CVP Manometer
Overhead Counterpoise System II
Pediatric Venous Cannulae
Perfusion Custom Packs
Polytrode Sensor
Power Processor 3060 Tube Sockyard
S/5 Arespire 7100 Trolley LH 2 VAP
Sequoia Oxymatic Electronic Conserver
Servo I
Spot PT Lite Phototherapy System
STA Liatest Free Protein S
Stago PTT-LA
Stellant CT Inject. Syst-Syringe Heater
Synchron Systems Calibrator 5 Plus
Syndeo PCA Syringe Pump
TX/RX Head MR Coil
Vail Bed
Vision Treatment Plan & Image Software
Vitros Chemistry Products CRBM Slides
Vitros Chemistry Products GENT Reagent
Vitros Immunodiagnostic Total T4 Reagent
3M Tegaderm Transparent Dressing
A) Area Hemodialysis Delivery SystemB) Arena SPX Hemodialysis Delivery SystemC) System 1000 Dialysate Delivery Sys-Tina
A) Vapotherm 2000IB) Vapotherm 2000i - Cleaning KitC) Vapotherm 2000i - Transfer Cartridge
Accu-Check Aviva Meter
Eclipse
Eclipse
Eclipse
EV3 Goose Neck Microsnare Kits
N Latex SAA
Temporary Cylinder with Retention
Uniglide Femoral Drills
300 Watt Xenon Light Source
A) 3 Pedal FootswitchB) MicroChoice foot Control
Behring Bephelometer Pro Spec Analyzer
Clavicle Hook Plate
Coulter LH700 Series System
Fabius GS Anesthesia Machine
Intact Parathyroid Hormone Test Kit
MR Signa Advantage
Onetouch Suresoft Single use Lancing
Synchron CX5PRO Level Sense Board
Ultralite Model 370
Vitros Chemistry Products Vanc Reagent
Vitros ECI Immunodiagnostic System Soft
X-Systems MCC
Eclipse
A) Sterile Arthroscopic ACL PackB) Sterile Major Lower Extremity PackC) Sterile Total Hip PackD) Sterile Surgical/Arthroscopic P
Advantage ACTH Cartridge
Hysteroscopy Telescope
Liquid Unassayed Multiqual 1, 2, 3
Misys Laboratory System Version 6.1
Mylab 30CV Ultrasound System
Varis Vision EVI, RTP Exchange all ver
Vision Treatment/EVI, RTP Exchange v6.6
A) Axiom Aristos FXB) Axiom Aristos MX
A) Bact/Alert 3DB) Bact/Alert 3D 60C) Bact/Alert 3D Combi
A) Bard Luminexx 3 Vascular StentB) Bard Luminexx 3 Vascular Stent
A) Enteryx InjectorB) Enteryx Procedure Kit
A) Freestyle Blood Glucose Monitor SystemB) Freestyle Mini Blood Glucose MonitorC) Precision Xtra Blood Glucose SystemD)
A) Insignia AVT SRB) Insignia AVT DDDC) Insignia AVT DRD) Insignia ENTRA DDDE) Insignia AVT VDDF) Insignia AVT SSIG) Insign
A) Magnetom Harmony MRI SystemB) Magnetom Sonata MRI SystemC) Magnetom Symphony MRI System
A) N/T Protein Controls SLB) N Protein SL
A) SmartCycler Software v1.6, 1.7, 1.7aB) SmartCycler Software v1.6, 1.7, 1.7a
A) Symmetry Balloon Dilatation CatheterB) Talon Balloon Dilatation Catheter
A) Synchron LX Systems Software V.4.5 / 4.6B) Synchron LX Systems Software v.4.5/4.6C) Synchron LX Systems Software v.4.5
Accucheck Advantage Accudata GTS
Actin FS Activated PTT Reagent
Amplatzer Duct Occluders
CD-Chex Plus CD4 Low Control
DIM GGT G Glutamyl Transferase Flex
Glycohemoglobin A1c control level 1,2
Immuno-trol & Immuno-trol Low Cells
Kallestad Anti-DSDNA Microplate EIA
Liquicheck D-Dimer Control
MDA System - Verical Set
Oscor 7 FR Introducer Kit
Osseotite Certain Implant
Peelaway Introducer Sheath
Rapid Urine Combo 5 Panel
Reagent Red Blood Cells Referencells A1 & B
Sienet Cosmos
A) Accuguide Seldinger Double Lumen PICCB) Accuguide Seldinger Double Lumen PICCC) Accuguide Seldinger Double Lumen P
A) Celsius ThermoCool Diagnostic/AblationB) Navistar Thermocool Diagnostic/Ablation     C) Celsius ThermoCool Diagnos
A) Chemosite System Introducer KitsB) Chemosite System - Ports
A) Precision 500D R/F SystemB) Proteus X-Ray System
BacT/Alert BPA/BPN
Bigliani / Flatow Complete Shoulder Solution TM Glenoid
Force FX Electrosurgical Generator
Sonoline Antares Ultrasound System
Stem-Trol Control Cells
Suction Regulator and Accessories
Synchron CX Systems RF Reagent & Calibrator
A) ACL Futur A/ACLl AdvanceB) ACL Top
Pyramidal Tip Obturator
Gemini GXL 6/10/16 Slice Pet/CT System
Galileo Immuno Haematology System
CoolGard 3000
Synchron CRP
Eclipse and Vision Version 6.5
Synchron Clinical Sys. Alcohol Reagent
Synchron EL-ISE Potassium Electrode Tip
Synchron Systems Ammonia Reagent
Retic-C Cell Control Level II
B65 Cool Coil
BD L-Cath 16 Gauge Dual Lumen
DIFCO LPM Agar Base
6060 Set with Pre-Attached 250 ml Bag
A) LCS Complete Knee System-RP InsertB) PFC Modular Knee System-Stab Tibial INSC) PFC Sigma Knee System-All Polyeth
Unvisor Ultrasound System
A) Arthrogram TrayB) Thoracentesis / Paracentesis Trays
A) Giraffe IncubatorB) Omnibed
Simplastin HTF
HDI 4000 Ultrasound System
Simplastin HTF
Citrol Level I, II Assayed-Euro Format
A) Flo-Gard 6201 Volumetric Infusion PumpB) Flo-Gard 6301 Volumetric Infusion Pump
AS50 Infusion Pump
A) Arro BedB)Spirit Bed
P1400 Century+ Beds
A) BD 25 Gauge Spinal NeedleB) BD 25 Gauge Spinal Needle
A) Referencells 2x10 MLB) Referencells 4x10 ML
Access Immunoassay Cortisol Reagent
Act5Diff Autoloader Hematology Analyzer
Buretrol IV Solution Set
Diamed AG ID-HBS Reducing Agent
Entrust ICD
Facelift Pack
On-Board Imager
Onetouch Ultra Warranty Meters
Power Processor 3060
Swiss Lithoclast Ultra Handpiece Kit
Versapoint Hysteroscopic Twizzle Tip
Voxel Q Field Upgrade to SCQSIM
A)Biograph Duo LSOB)Biograph LSO 16
A)One Touch Fast Take MeterB)Induo MeterC)Induo System KitD)Onetouch Ultra Meter
Arroe Trerotola Over the Wire PTD
Continuum MR Compatible Infusion System
Damon 3 Bracket
Flexible Implant Tube, Blind end 350 mm
Model 555 Pediatric Underbody Blanket
Oxinium Femoral Head
PTFE FELTS
Puritan Bennett 840 Ventilator Lic# 9957
Reflection Threaded Hole Cover
Spirit MB Bracket
A) Custom Spinal Anesthesia Tray B) Spinal Anesthesia Tray
A) Total Hip PackB) Total Knee Pack
Custom Sterile Spinal Pack
GST418 - Breast Pack
Quicksilver Biploar Coagulation Probe
A)Axiom Artis DFC B)Axiom Artis FA AlphaC)Axiom Artis MP DiagnosticD)Axiom Artis TA
Axiom Artis MP
MABPDE
Simview 3000
list/index-eng.php


                                                Manufacturer
            Becton Dickinson Infusion Therapy Systems Inc.
            Biomerieux, Inc.
            Technidata S.A.S.
            Technidata S.A.S.
            Roche Diagnostics GMBH
            Beckman Coulter, Inc.
            Beckman Coulter, Inc.
            Gyrus Acmi, Inc.
            Stryker Orthopeadics
            Howmedica Osteonics Corporation
            Abbott Laboratories Diagnostic Division
            Bio-Rad Laboratories Deeside
            Philips Medzin Systeme Boeblingen GMBH
            Stryker Instruments
            Cardinal Health
            Roche Diagnostics GMBH
            Roche Diagnostics GMBH
            Philips Medical Systems
            Ortho-Clinical Diagnostics Inc.
            CaridianBCT, Inc.
            Vital Diagnostics, Inc.
            Siemens Healthcare Diagnostics Inc.
            Immuontech A.S.
            Hospira Inc.
            Diasorin Inc.
            Smith & Nephew, Inc., Endoscopy Division
            Abbott Point of Care Inc.
            Prollenium Medical Technologies Inc.
            Johnson & Johnson Vision Care, Inc.
            Roche Diagnostics GMBH
            Roche Diagnostics GMBH
            Boston Scientific Corporation
            Siemens AG
            Beckman Coulter, Inc.
            Datascope Corp.
            Beckman Coulter, Inc.
            Elekta Business Area Software Systems ATA Computerized Medical Systems Inc.
            Elekta Business Area Software Systems ATA Computerized Medical Systems Inc.
            Ace Surgical Supply Co. Inc.
            Remington Medical, Inc.
            Abbott Point of Care Inc.
Cardiac Pacemakers Incorporated
Escalon Medical Corp.
Navilyst Medical, Inc.
Voco GMBH
Varian Medical Systems, Inc.
Siemens Healthcare Diagnostics Inc.
Medrad Inc.
Smith & Nephew, Inc.
International Technidyne Corp.
Philips Medical Systems
Diagnostica Stago SAS
Abbott Laboratories Diagnostic Division
Micro Typing Systems Inc.
Micro Typing Systems Inc.
Boston Scientific Corporation
Medrad Inc.
Toshiba Medical Systems Corporation
Applied Medical Resources Corporation
Philips Medical Systems Nederland B.V.
Philips Medical Systems
Beckman Coulter, Inc.
Welch Allyn, Inc.
Beckman Coulter Inc.
Roche Diagnostics GMBH
Roche Diagnostics GMBH
Bausch & Lomb Inc.
Siemens AG
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Thermo Anatomical Pathology Microm
Steris Corporation
Steris Corporation
Siemens Healthcare Diagnostics Inc.
Intersurgical Incorporated
Bio-Rad Laboratories Europe Ltd.
Lifescan Inc.
Roche Diagnostics Ltd.
Invitrogen Corporation
Baxter Healthcare Corporation
GE Healthcare Finland OY
Siemens Healthcare Diagnostics Inc.
Pentron Clinical Technologies, LLC
Maddak Inc.
Dentsply Caulk
Invitrogen Corporation
Stryker Trauma GMBH
Smith & Nephew, Inc., Endoscopy Division
Siemens Medical Solutions USA, Inc. Oncology Care Systems
Siemens Medical Solutions USA, Inc.
Impac Medical Systems Inc.
Wescor Inc.
PML Microbiologicals, Inc.
Conmed Endoscopic Technologies, Inc.
Siemens Medical Solutions USA, Inc.
Immucor Inc.
Statspin Incorporated DBA Iris Sample Processing
Abbott GMBH & Co. K.G.
Invitrogen Corporation
Invitrogen Corporation
Biohorizons Implant Systems, Inc.
Tomotherapy Incorporated
Steris Corporation
Dana Douglas Inc.
Dana Douglas Inc.
Boston Scientific Corporation
Oxoid Limited
Depuy International Ltd.
3M Health Care
Cellestis Ltd.
Imtec Imaging, LLC
Fisher And Paykel Healthcare Ltd.
GE Medical Systems SCS
Siemens Healthcare Diagnostics Products GMBH
Randox Laboratories Ltd.
Howmedica Osteonics Corporation
Siemens Medical Solutions USA, Inc.
Boston Scientific Cork Ltd.
Boston Scientific Cork Ltd.
Sigma Diagnostics
Stryker Medical
Boston Scientific Corporation
Steris Corporation
Dentsply Tulsa Dental Specialties Trading As Dentsply Endodontics
Molnlycke Health Care AB
Zimmer Spine Austin, Inc.
GE Healthcare
Synthes (Canada) Ltd.
Siemens Healthcare Diagnostics Products Limited
Sorin Group Italia S.R.L.
Intuitive Surgical Inc.
Terumo Cardiovascular System Corporation
Ohmeda Medical, A Division Of Datex Ohmeda Inc.
Maquet GMBH & Co. KG
Linvatec Corporation D.B.A. Conmed Linvatec
Linvatec Corporation D.B.A. Conmed Linvatec
Nobel Biocare AB
Maquet S.A.
Siemens Healthcare Diagnostics Products GMBH
Termo Cardiovascular System Corporation
Thermo Fisher Scientific OY
Ormco Corporation
Siemens Healthcare Diagnostics Inc.
Dentsply Tulsa Dental Specialties Trading As Dentsply Endodontics
Stryker Instruments
Gyrus Acmi, Inc.
Edwards Lifesciences
Hoya Conbio
Boston Scientific Cork Ltd.
Unomedical Inc.
Medtronic Sofamor Danek USA, Inc.
Implant Direct LLC
Boston Scientific Corporation
Maquet S.A.
Medi-Tech Boston Scientific Corporation
Siemens AG
Siemens AG
Fisher And Paykel Healthcare Ltd.
Olsen Medical
Cooper Surgical Inc. Also Trading As Wallach Surgical Devices
Siemens Healthcare Diagnostics Products GMBH
Computerized Medical Systems, Inc. (DBA CMS, Inc.) The Elekta Group
Siemens Medical Solutions USA, Inc.
Haag-Streit, AG
Diasorin Inc./S.R.L.
Siemens Medical Solutions USA, Inc.
GE Medical Systems Kretztechnik GMBH & CO OHG
Smith & Nephew, Inc.
Siemens Medical Solutions USA, Inc. Oncology Care Systems
Fisher And Paykel Healthcare Ltd.
Penumbra Inc.
Smiths Medical PM, Inc.
Smith & Nephew, Inc., Endoscopy Division
PBN Medical Denmark A/S
Orthofab Inc.
Roche Diagnostics GMBH
Roche Diagnostics GMBH
Diagnostic Hybrids, Inc.
Ethicon Inc. Also Trading As Ethicon Women'sHealth And Urology
Fisher And Paykel Healthcare Ltd.
Bio-Rad Laboratories Diagnostics Group
Sandhill Scientific Inc.
Invitrogen Corporation
Smith & Nephew, Inc.
Zimmer Inc.
Ethicon Inc.
Advanced Sterilization Products, A Division Of Ethicon
GE Medical Systems Information Technologies
Thoratec Corporation
Stryker Spine SAS
Wallac OY
Bard Peripheral Vascular, Inc.
GE Medical Systems SCS
Medtronic Inc.
Zimmer Inc.
DXS Ltd.
A-Dec, Inc.
Immucor Inc.
Synthes (Canada) Ltd.
Linvatec Corporation D.B.A. Conmed Linvatec
Zimmer Dental Inc.
Respironics Inc.
GE Healthcare IT
Accuray, Inc.
Baxter Healthcare Corporation
Elekta Instruments AB
Zimmer Inc.
Sysmex Reagents America
Zimmer GMBH
KCI USA, Inc.
Remel Europe Ltd.
Medical Device Technologies, Inc. DBA Angiotech
Natus Medical Inc.
Beckman Coulter Inc.
Derma Sciences, Inc.
Siemens Medical Solutions USA, Inc. Oncology Care Systems
Spacelabs Medical, Inc.
Stryker Communications
Smiths Medical MD Inc.
Bio-Rad Laboratories Diagnostics Group
Getinge Sourcing LLC.
Elekta Instruments AB
Stryker Endoscopy
Trinity Biotech PLC
Advanced Bionics, LLC
Smith & Nephew, Inc.
Medxl Inc.
Beckman Coulter Inc.
Trinity Biotech PLC
Immucor Inc.
Immucor Inc.
Oxoid Limited
Doctors Research Group Inc.
GE Medical Systems LLC
GE Healthcare Japan Corporation
Siemens Healthcare Diagnostics Inc.
Beckman Coulter, Inc.
Baxter Healthcare Corporation
Zimmer CAS
Stryker Instruments
Medtronic Spine LLC
Nonin Medical Inc.
Varian Medical Systems, Inc.
Varian Medical Systems, Inc.
Becton Dickinson Infusion Therapy Systems Inc.
Roche Diagnostics GMBH
The Ohio Willow Wood Company
Impac Medical Systems Inc.
Trinity Biotech PLC
Trinity Biotech PLC
Boston Scientific Corporation
Boston Scientific Corporation
Getinge Disinfection AB
Vascular Solutions, Inc.
Siemens AG
Advanced Medical Optics, Inc.
Advanced Medical Optics, Inc.
Cardiac Science Corporation
3M Health Care
Animas Corporation
Lifescan Inc.
Brainlab AG
Siemens Healthcare Diagnostics Inc.
Siemens AG
Bio-Rad
Remel Inc.
Berlin Heart GMBH
Toshiba Medical Systems Corporation
Imaging Sciences International, Inc.
Walter Lorenz Surgical, Inc. Also trading as: Biomet Microfixation
Biosense Webster (Israel) Ltd.
Imaging Sciences International, Inc.
Biosite Incorporated
Immucor Inc.
New Deal SA
Roche Molecular Systems, Inc.
Becton Dickinson Canada Inc.
Siemens Healthcare Diagnostics Inc.
Siemens Healthcare Diagnostics Products GMBH
Fisher And Paykel Healthcare Ltd.
Accuray, Inc.
Edwards Lifesciences LLC
Cyberonics Inc.
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Abbott Point Of Care Inc.
Litecure, LLC
Siemens Healthcare Diagnostics Inc.
GE Healthcare
Radiometer Medical APS
Wallac OY
Gyrus Acmi, Inc.
Zimmer Inc.
Phadia AB
Biomet, Inc.
Nobel Biocare AB
Hill-Rom Manufacturing, Inc.
Abbott Laboratories Diagnostic Division
Abbott Vascular
Data Innovations
Siemens Healthcare Diagnostics Inc.
Brainlab AG
Stryker Communications
Toshiba Medical Systems Corporation
Ortho-Clinical Diagnostics Inc.
Cardiac Science Corporation
Smith & Nephew, Inc.
Stryker Medical
Howmedica Osteonics - Stryker Ireland
Keymed (Medical & Industrial Equipment) Ltd.
Arjo Hospital Equipment AB
Becton, Dickinson And Company
Smith & Nephew, Inc.
Zimmer Inc.
Olympus Winter & IBE GMBH
Abbott Ireland Diagnostics Division
Smith & Nephew Orthopaedics Ltd.
Howmedica Osteonics Corporation
Advanced Bionics, LLC
Roche Diagnostics Ltd.
GE Healthcare Integrated IT Solutions
Arrow International, Inc.
Roche Diagnostics GMBH
Kuschall AG
Sysmex Reagents America
AGFA Healthcare N.V.
Breg, Inc.
Siemens Medical Solutions USA, Inc.
OSSUR HF
Medrad Inc.
Howmedica Osteonics Corporation
Howmedica Osteonics - Stryker Ireland
Unomedical A/S
Whatman, Part Of GE Healthcare
Philips Medical Systems DMC GMBH
GE Healthcare
GE Healthcare
GE Healthcare
Philips Medical Systems (Cleveland), Inc.
Walter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation
PML Microbiologicals, Inc.
Body Health S.A.
J. T. Posey Co.
Beckman Coulter Inc.
GE Healthcare
Immucor Inc.
Vital Signs Inc.
Baxter Healthcare Corporation, Edwards Critical-Care Division
Ormco Corporation
Medtronic Inc.
Roche Diagnostics GMBH
Trinity Biotech PLC
Trinity Biotech PLC
Trinity Biotech PLC
Phadia GMBH
Cardinal Health
Varian Medical Systems, Inc.
Biosite Incorporated
Abbott Laboratories Diagnostic Division
Philips Medical Systems (Cleveland), Inc.
Corin Limited
GE Healthcare
Cardinal Health 209, Inc. DBA Viasys Healthcare Inc, Viasys Neurocare
GE OEC Medical Systems Inc.
Stryker Instruments
Accuray, Inc.
Respironics Inc.
Vascular Solutions, Inc.
Siemens Healthcare Diagnostics Inc.
Siemens Healthcare Diagnostics Inc.
Roche Molecular Systems, Inc
Berchtold Medizen-Elektronik GMBH
Welch Allyn Protocol, Inc.
GE Medical Systems LLC
Howmedica Osteonics Corporation
Welch Allyn Protocol, Inc.
Smith & Nephew, Inc.
Cardinal Health
GE Medical Systems SCS
GE Medical Systems SCS
Howmedica Osteonics - Stryker Ireland
Respironics Inc.
Diagnostic Systems Laboratories Inc., DSL
GE Healthcare
Stryker Instruments
Smith & Nephew, Inc., Endoscopy Division
Accuray, Inc.
Teleflex Medical
Bio-Rad Laboratories Diagnostics Group
Beckman Coulter Inc.
Zimmer Inc.
Remel Europe Ltd.
Welch Allyn Protocol, Inc.
Remel Europe Ltd.
Oxoid Limited
Medtronic Xomed
Scalp Laser
Technidata S.A.S.
Roche Diagnostics GMBH
Roche Diagnostics GMBH
Teleflex Medical
Philips Medical Systems
Linvatec Corporation D.B.A. Conmed Linvatec
Linvatec Corporation D.B.A. Conmed Linvatec
Toshiba Medical Systems Corporation
Unipath Limited
Siemens AG
William A. Cook Australia, PTY. Ltd.
Boston Scientific Corporation
Coloplast A/S
Cyberonics Inc.
Philips Medical Systems Nederland B.V.
Bomimed Inc.
Zimmer Inc.
Hurricane Medical
Linvatec Corporation D.B.A. Conmed Linvatec
GE Healthcare Finland OY
Cyberonics Inc.
Boston Scientific Microvasive
Tomotherapy Incorporated
Becton Dickinson And Company
Picis Inc.
Covidien LP - Respiratory & Monitoring Solutions GBU
Draeger Medical Systems, Inc.
Siemens Medical Solutions USA, Inc.
Gyrus Acmi, Inc.
Boston Scientific Corporation
Boston Scientific Corporation
Linvatec Corporation D.B.A. Conmed Linvatec
The Anspach Effort Inc.
Brainlab AG
Hospira Inc.
Immucor Inc.
Implant Direct LLC
Boston Scientific EP Technologies
Smiths Medical International Ltd.
Immucor Inc.
Philips Medical Systems
Pentron Clinical Technologies, LLC
Carl Zeiss Meditec Inc.
Beckman Coulter Inc.
Beckman Coulter Inc.
Beckman Coulter Inc.
Philips Medical Systems Nederland B.V.
Abbott Laboratories Diagnostic Division
Siemens Healthcare Diagnostics Inc.
Ortho-Clinical Diagnostics Inc.
Merit Medical Systems Inc.
Resmed Paris
Medi-Tech Boston Scientific Corporation
Depuy Orthpaedics, Inc.
Smith & Nephew, Inc., Endoscopy Division
Steris Corporation
Picis Inc.
Data Innovations
Becton, Dickinson And Company
Getinge Disinfection AB
Mediland Enterprise Corporation
Smith & Nephew, Inc., Endoscopy Division
GE Healthcare
Zimmer Inc.
Zimmer Inc.
Zimmer Inc.
Philips Medical Systems Nederland B.V.
GE Medical Systems Information Technologies
GE Healthcare
GE Healthcare
Trainer's Choice
Philips Medizin Systeme Boeblingen GMBH
Siemens AG
GE Healthcare
J T Posey Co.
Biotest Medical Diagnostics GMBH
Varian Medical Systems, Inc.
Philips Medical Systems Nederland B.V.
Philips Medizin Systeme Boeblingen GMBH
Philips Medical Systems (Cleveland), Inc.
GE Healthcare
Baxter Healthcare Corporation
Vital Signs Inc.
Ossur HF
Roche Diagnostics Ltd.
Medtronic Inc.
Maquet Cardiopulmonary AG
Abbott Laboratories Diagnostic Division
Philips Medical Systems Nederland B.V.
White Peaks Dental Systems
Boston Scientific Neuromodulation Corporation
Stryker Endoscopy
Siemens Healthcare Diagnostics Inc.
Terumo Cardiovascular Systems Corp.
Stryker Communications
Siemens Medical Solutions USA, Inc. Oncology Care Systems
BHM Medical Inc.
Maquet Critical Care AB
Roche Diagnostics GMBH
Labvision Corporation - Part Of Thermo Fisher Scientific
Ansell Healthcare Products LLC
Harvest Technologies Corp.
Diagnostica Stago SAS
Hamilton Medical AG
Dominion Biologicals Ltd.
Smith & Nephew, Inc.
Smith's Medical MD Inc.
M.C. Healthcare Products Inc.
Hyphen Biomed
Sorin Group Italia S.R.L.
Boston Scientific Corporation
Boston Scientific Corporation
Zimmer Inc.
Boston Scientific Corporation
Boston Scientific Microvasive
Varian Medical Systems, Inc.
Philips Medical Systems DMC GMBH
Encore Medical, L.P.
Respironics California, Inc.
Siemens Healthcare Diagnostics Inc.
Remel Europe Ltd.
Becton Dickinson And Company
Randox Laboratories Ltd.
Millipore Corporation Bioscience Division
Imaging Sciences International, Inc.
Abbott Molecular Inc.
Terumo Cardiovascular Systems Corp.
Bio-Rad Laboratories Diagnostics Group
Bio-Rad Laboratories
Draeger Medical B.V.
Tremblay Harrison Inc.
Philips Medical Systems Nederland B.V.
GE Medical Systems Kretztechnik GMBH & CO OHG
Ohmeda Medical, A Division Of Datex Ohmeda Inc.
Baxter Healthcare Corporation
Medtronic Inc.
Immucor Inc.
Problem Solving Concepts, Inc.
GE Healthcare
Draeger Medical AG & CO. KG
Howmedica Osteonics Corporation
Beckman Coulter Inc.
GE Healthcare
Vibe Technologies
Technidata S.A.S.
Howmedica Osteonics - Stryker Ireland
GTI, Inc.
Siemens AG
GE Healthcare
Biomet Orthopedics, Inc.
Cardinal Health
GE OEC Medical Systems Inc.
Bard Access Systems, Inc.
Siemens Healthcare Diagnostics Inc.
Draeger Medical B.V.
GE Healthcare
GE Healthcare Integrated IT Solutions
Philips Medical Systems (Cleveland), Inc.
GE Healthcare
Baxter Healthcare Corporation
Datex-Ohmeda, Inc.
The Ohio Willow Wood Company
Boston Scientific Corporation
Synthes (Canada) Ltd.
Siemens Medical Solutions USA, Inc. Oncology Care Systems
Miltex, Inc.
Invivo Corporation
GE Healthcare
Bard Access Systems, Inc.
Immucor Inc.
Fuji Film Medical Systems USA, Inc.
Beckman Coulter Inc.
Boston Scientific Neuromodulation Corporation
Philips Medical Systems (Cleveland), Inc.
Medtronic Minimed
DEL Medical Imaging Corporation
Boston Scientific Microvasive
Fresenius AG
GE Healthcare
GE OEC Medical Systems Inc.
Biomet, Inc.
GE Healthcare Integrated IT Solutions
GE Healthcare
GE Healthcare Findland OY
Siemens Healthcare Diagnostics Inc.
Depuy Spine
Advanced Sterilization Products, A Division Of Ethicon
Coloplast A/S
Stille AB
Oxoid Limited
Bio-Rad Laboratories Diagnostics Group
Elekta Limited
Walter Lorenz Surgical, Inc. Also Trading As:Biomet Microfixation
Ortho-Clinical Diagnostics Inc.
Technidata S.A.S.
Datex-Ohmeda, Inc.
Edwards Lifesciences LLC
Zimmer Inc.
Zimmer GMBH
Toshiba Medical Systems Corporation
Zimmer Inc.
Abbott GMBH & Co. K.G.
Biomet Sports Medicine, Inc.
Howmedica Osteonics Corporation
Howmedica Osteonics Corporation
Immunodiagnostic Systems Ltd.
Maquet Cardiovascular LLC
Maquet Cardiovascular LLC
Bard Access Systems, Inc.
Computerized Medical Systems
Beckman Coulter Inc.
Cardinal Health
Genzyme Diagnostics P.E.I. Inc.
Armstrong Medical Limited
Nipro Corporation
Ethicon Inc.
Philips Medical Systems (Cleveland), Inc.
Fresenius Medical Care North America
Smith & Nephew, Inc.
Smith & Nephew, Inc.
Baxter Healthcare Corporation
Smith & Nephew, Inc.
Biomet, Inc.
BHM Medical Inc.
Technidata S.A.S.
Roche Diagnostics GMBH
Physio-Control, Inc.
Roche Diagnostics Ltd.
Gendex Corporation DBA Gendex Dental Systems
Maquet GMBH & Co. KG
B-K Medical
Conmed Corporation
Ormco Corporation
Stryker Communications
Beckman Coulter Inc.
Kerr Corporation
Arjo Hospital Equipment AB
Ormco Corporation
Animas Corporation
GE Healthcare Integrated IT Solutions
Medtronic Inc.
Siemens Medical Solutions USA, Inc.
Stryker Communications
Walter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation
Pascal Company Inc.
Medtronic Inc.
Siemens AG
Advanced Sterilization Products, A Division Of Ethicon
Smith & Nephew Inc. Wound Management Division
Abbott Laboratories Diagnostic Division
Abbott Laboratories Diagnostic Division
Surgical Specialties Corporation, Also Doing Business As Angiotech
Rapid Diagnostics, Division Of MP Biomedicals, Inc.
Beckman Coulter Inc.
Abbott Molecular Inc.
Applied Cardiac Systems Inc.
Medrad Inc.
Tomotherapy Incorporated
Microgenics Corporation
Siemens AG
J. T. Posey Co.
Boston Scientific Corporation
Tripath Imaging, Inc.
GE Healthcare
Terumo Cardiovascular Systems Corp.
Terumo Cardiovascular Systems Corp.
Becton Dickinson Diagnostic Instrument Systems
Becton Dickinson Diagnostic Instrument Systems
Ferno, Division Of Ferno-Washington Inc.
Thoratec Corporation
Siemens Healthcare Diagnostics Inc.
Synthes (Canada) Ltd.
Siemens Healthcare Diagnostics Inc.
Beckman Coulter Inc.
Gambro Lundia AB
Smith & Nephew, Inc.
Siemens AG
Stryker Endoscopy
Stryker Instruments
Pentron Clinical Technologies, LLC
Gambro Dasco S.P.A.
BHM Medical Inc.
Depuy France S.A.S.
Smiths Medical International Ltd.
Biosense Webster Inc.
Beckman Coulter Inc.
Barrx Medical Inc.
Siemens AG
Medtronic Inc.
Ortho-Clinical Diagnostics Inc.
Bio-Rad Laboratories Diagnostics Group
Fisher And Paykel Healthcare Ltd.
BHM Medical Inc.
Phadia GMBH
Siemens Medical Solutions USA, Inc. Molecular Imaging Group
Bard Access Systems, Inc.
Stryker Leibinger GMBH & Co. KG
Beckman Coulter Inc.
Smiths Medical International Ltd.
Stryker Medical
Smith & Nephew, Inc., Endoscopy Division
Thoratec Corporation
Orasure Technologies, Inc.
Tomotherapy Incorporated
Oscor Inc.
C.R. Bard, Inc.
Cook Urological Inc.
Immucor Inc.
GE Healthcare
Medi-Plinth Equipment Ltd.
Immucor Inc.
Terumo Cardiovascular Systems Corp.
Terumo Cardiovascular Systems Corp.
Terumo Cardiovascular Systems Corp.
Immucor Inc.
Intelerad Medical Systems Incorporated
Curlin Medical, LLC
Philips Medizin Systeme Boeblingen GMBH
Hill-Rom Manufacturing, Inc.
Ortho-Clinical Diagnostics Inc.
Hill-Rom Company, Inc.
Inpeco Spa
Beckman Coulter Inc.
Beckman Coulter Inc.
Stryker Trauma AG
Baxter Healthcare Corporation
Technidata S.A.S.
Abbott Laboratories Diagnostic Division
Thoratec Corporation
Clinical Instruments International Inc.
Welch Allyn Canada Limited
Roche Diagnostics GMBH
Stryker Instruments
Immco Diagnostics Inc.
Smiths Medical ASD Inc.
Oxoid Limited
Siemens AG
Siemens Medical Solutions USA, Inc. Oncology Care Systems
Impac Medical Systems Inc.
Abbott Molecular Inc.
Abbott Molecular Inc.
Oxoid Limited
Oxoid Limited
Ohmeda Medical, A Division Of Datex Ohmeda Inc.
Oxoid Limited
Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions USA, Inc. Oncology Care Systems
Walter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation
BHM Medical Inc.
Advanced Sterilization Products, A Division Of Ethicon
Roche Diagnostics GMBH
Radiometer Medical APS
Kerr Corporation
Maquet GMBH & Co. KG
KCI USA, Inc.
Smiths Medical MD Inc.
Stryker Leibinger GMBH & Co. KG
Siemens Healthcare Diagnostics Inc.
Synthes (Canada) Ltd.
Siemens Healthcare Diagnostics Products Limited
Kettenbach GMBH & Co. KG
Baylis Medical Company Inc.
Philips Medical Systems Nederland B.V.
Roche Diagnostics Ltd
Toshiba Medical Systems Corporation
Toshiba Medical Systems Corporation
Philips Medical Systems Nederland B.V.
Convatec Inc.
Abbott Laboratories Diagnostic Division
Smith & Nephew, Inc.
Siemens Healthcare Diagnostics Inc.
Siemens Healthcare Diagnostics Products Limited
Coloplast A/S
Biomerieux Inc.
Philips Medical Systems Nederland B.V.
Philips Medical Systems Nederland B.V.
Physio-Control, Inc.
Inpeco Spa
Philips Medical Systems DMC GMBH
Walter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation
Abbott Vascular
Invacare Corporation
Philips Medical Systems (Cleveland), Inc.
Computerized Medical Systems
Siemens Healthcare Diagnostics Inc.
Medtronic Inc.
Diasorin Inc./S.R.L.
Ethicon Endo-Surgery, LLC
Animas Corporation
KCI USA, Inc.
Stryker Medical Quebec LP
Stryker Medical Quebec LP
Siemens Healthcare Diagnostics Products GMBH
Varian Medical Systems, Inc.
Varian Medical Systems, Inc.
Biomerieux, Inc.
Edwards Lifesciences LLC
Becton Dickinson And Company
J T Posey Co.
Sybron Endo
Varian Medical Systems, Inc.
Varian Medical Systems, Inc.
Sirona Dental Systems GMBH
Sirona Dental Systems GMBH
Roche Diagnostics GMBH
Griener Bio One North America, Inc.
Cardinal Health
Spacelabs Medical, Inc.
Welch Allyn, Inc.
Vital Signs Inc
Beckman Coulter Inc.
Chart Industries, Inc. DBA Caire, Inc.
Immucor Inc.
Immucor Inc.
Toshiba Medical Systems Corporation
Cordis Corporation
Roche Diagnostics GMBH
Immco Diagnostics Inc.
Cybernius Medical Ltd.
Siemens AG
Varian Medical Systems UK, Ltd.
Beckman Coulter Inc.
Beckman Coulter Inc.
Siemans AG Medical Solutions
Medtronic Inc.
Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions USA, Inc.
Physio-Control, Inc.
Stryker Communications
Ferno, Division Of Ferno-Washington Inc.
Becton Dickinson And Company
The Anspach Effort Inc.
Remel Inc.
Siemens Healthcare Diagnostics Inc.
Siemens Healthcare Diagnostics Inc.
Teleflex Medical
Inpeco Spa
Zeus Scientific Inc.
Varian Medical Systems, Inc.
Siemens Medical Solutions Diagnostics Limited
Siemens Medical Solutions Diagnostics Limited
Physio-Control, Inc.
Cardinal Health
Siemens Medical Solutions USA, Inc. Oncology Care Systems
National Biological Corp
Convatec, A Division Of E.R. Squibb & Sons, L.L.C.
Diagnostic Chemicals LimitedGenzyme Diagnostics P.E.I. Inc.
EV3 Inc.
Microgenics Corporation
A.L.N.
Ortho-Clinical Diagnostics Inc.
3M ESPE Dental Products
Hologic, Inc.
Medtronic Inc.
Bio-Rad Laboratories Diagnostics Group
Roche Diagnostics GMBH
Linvatec Corporation D.B.A. Conmed Linvatec
Implant Innovations, Inc.Also Trading As Biomet 3I
Varian Medical Systems, Inc.
Varian Medical Systems, Inc.
Custom Ultrasonics Inc.
Implant Innovations, Inc.Also Trading As Biomet 3I
Biomerieux, Inc.
Varian Medical Systems, Inc.
BHM Medical Inc.
Siemens Healthcare Diagnostics Inc.
Elekta Limited
Siemens Healthcare Diagnostics Inc.
Bausch & Lomb Inc.
Medtronic Inc.
Smiths Medical PM, Inc.
Biosense Webster Inc.
Medtronic Inc.
Levitronix GMBH
Given Imaging Ltd.
Siemens Medical Solutions USA, Inc.
Siemens AG
Cardinal Health
Draeger Medical B.V.
Biosite Incorporated
Zimmer Orthopaedic Surgical Products
Gambro Lundia AB
Walter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation
Siemens Healthcare Diagnostics Inc.
Bio-Rad Laboratories Diagnostics Group
Tornier
Georg Kramer GES. M.B.H. & Co. KG
Chattanooga Group A Divison Of Encore Medical, L.P.
BHM Medical Inc.
AGA Medical Corporation
Imaging Sciences International, Inc.
Abbott Laboratories Diagnostic Division
Philips Medical Systems
Nova Biomedical Corporation
Tenet Medical Engineering, Inc.
Randox Laboratories Ltd.
Philips Medical Systems (Cleveland), Inc.
Philips Medical Systems (Cleveland), Inc.
Cardiac Pacemakers Incorporated
Hill-Rom Company, Inc.
Walter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation
Roche Diagnostics GMBH
Tyco Healthcare Liebel-Flarsheim Company
Tyco Healthcare Liebel-Flarsheim Company
Bio-Rad Laboratories Diagnostics Group
Ortho-Clinical Diagnostics Inc.
Dade Behring Marburg GMBH
Depuy Mitek
Cryocath Technologies Inc.
Hill-Rom Company, Inc.
Roche Diagnostics GMBH
Zimmer Orthopaedic Surgical Products
Abbott Laboratories Diagnostic Division
Siemans Medical Solutions USA, Inc.
Pulmonetic Systems, Inc.
Thought Technology Ltd.
Siemens Medical Solutions USA, Inc. Oncology Care Systems
Siemens Healthcare Diagnostics Inc.
Vioptix, Inc.
Oxoid Company
Imaging Sciences International, Inc.
Cardinal Health
Stryker Endoscopy
Howmedica Osteonics Corporation
Becton Dickson And Company
Ethicon Endo-Surgery, LLC
Cook, Inc.
Siemens Medical Solutions USA, Inc.
Gambro Renal Products S.A. DE C.V.
Advanced Sterilization Products, A Division Of Ethicon
Physio-Control, Inc.
Arrow International, Inc.
Physio-Control, Inc.
Elekta Limited
Kyphon Inc.
Toshiba Medical Systems Corporation
Abbott Laboratories Diagnostic Division
Philips Medical Systems DMC GMBH
Inova Diagnostics Inc
Siemens Healthcare Diagnostics Inc.
Terumo Cardiovascular Systems Corp.
Thermogenesis Corp.
Philips Healthcare Informatics, Inc.
Computerized Medical Systems
Immucor Inc.
Maquet Cardiopulmonary AG
Medtronic Inc.
Gambro Renal Products S.A. DE C.V.
GE OEC Medical Systems Inc.
International Technidyne Corp.
Siemens Healthcare Diagnostics Inc.
GE Healthcare
Mimvista Corp.
Stryker Endoscopy
GE Healthcare
Steris Corporation
Cardinal Health
Siemens Medical Solutions USA, Inc. Oncology Care Systems
Siemens AG
Beckman Coulter Inc.
GE Healthcare
Siemens AG
Siemens Medical Solutions USA, Inc. Oncology Care Systems
Trinity Biotech USA
Beckman Coulter Inc.
Siemens Healthcare Diagnostics Inc.
Walter Lorenz Surgical, Inc.Also Trading As : Biomet Microfixation
Siemens Medical Solutions USA, Inc. Oncology Care Systems
Nonin Medical Inc.
Siemens Healthcare Diagnostics Inc.
AGFA Healthcare Corporation
Elekta Limited
Abbott Laboratories Diagnostic Division
Siemens Healthcare Diagnostics Inc.
Medtronic Minimed
Physio-Control, Inc.
Zimmer Inc.
Cordis Corporation
Philips Medical Systems DMC GMBH
Roche Diagnostics GMBH
Medtronic Inc.
Abbott Laboratories Diagnostic Division
Computerized Medical Systems
Varian Medical Systems, Inc.
Henry Schien Ash Arcona Inc.
Cardinal Health 303, Inc.
Bio-Rad Laboratories Diagnostics Group
Bio-Rad Laboratories Diagnostics Group
Bio-Rad Laboratories Diagnostics Group
Roche Diagnostics GMBH
Roche Diagnostics GMBH
BHM Medical Inc.
Animas Corporation
Philips Medical Systems Nederland B.V.
Allied Healthcare Products Inc
Philips Medical Systems
M.C. Healthcare Products Inc.
Becton, Dickinson and Company
Becton Dickinson
Becton, Dickinson and Company
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Precept
Siemens Medical Solutions Diagnostics
Conmed Corporation
Cardinal Health
Roche Diagnostics GMBH
Howmedica Osteonics - Stryker Ireland
Arrow International, Inc.
Becton Dickinson and Company
Cook, Inc.
Toshiba Medical Systems Corporation
Chiu Technical Corp.
Datascope Corp. (Patient Monitoring Division)
Siemans Medical Solutions USA, IncOncology Care Systems
Howmedica Osteonics Corporation
Balt Extrusion
Electro Medical Systems (EMS) SA
Amo Manufacturing USA, LLC
Roche Diagnostics GMBH
The Ohio Willow Wood Company
Focus Diagnostics, Inc
Carestream Health, Inc.
Walter Lorenz Surgical, Inc. also trading as:Biomet Microfixation
Zoll Medical Corporation
Cordis Europa N.V.
Howmedica Osteonics - Stryker Ireland
Howmedica Osteonics - Stryker Ireland
Conmed Corporation
Elekta Instruments AB
Dade Behring Marburg GMBH
Varian Medical Systems, Inc.
Technidata S.A.S.
Toshiba Medical Systems Corporation
Elekta Limited
Dade Behring Inc.
Aesculap AG & CO. KG
Seradyn Inc.
Abbott Laboratories Diagnostic
Abbott Laboratories Diagnostic
Elekta Limited
Abbott Laboratories Diagnostic
Abbott Laboratories Diagnostic
ST. Jude Medical, Cardiac Rhythm Management Division
Draeger Medical AG & CO. KG
Smiths Medical MD Inc.
Advanced Bionics Corp.
Beckman Coulter Inc.
Stryker Instruments
Remel Inc.
Siemens Medical Solutions USA, Inc.
Siemens AG Medical Solutions
Ortho-Clinical Diagnostics Inc.
Zimmer GMBH
Zimmer Inc.
Zimmer GMBH
Computerized Medical Systems
Zimmer Orthopaedic Surgical Products
Advanced Sterilization Products, A Division Of Ethicon
Cardinal Health
Viasys Healthcare Inc., Neurocare Group,Grason Stadler Divisions
California Medical Laboratories, Inc.
Zimmer Orthopaedic Surgical Products
Roche Diagnostics GMBH
Smiths Medical MD Inc.
Abbott Laboratories Diagnostic Division
Smiths Medical MD Inc.
Dade Behring Inc
Dade Behring Marburg GMBH
Zimmer Orthopaedic Surgical Products
Siemens AG
Coopersurgical Inc.
Immucor Inc.
Maquet Critical Care AB
Maquet Cardiopulmonary AG
Radiometer Medical APS
Encore Medical, L.P.
Beckman Coulter Inc.
Bio-Rad Laboratories Diagnostics Group
Tomotherapy Incorporated
Olympus America, Inc. Diagnostic Systems Group
International Technidyne Corp.
Popper And Sons Inc.
Steris Corporation
Medtronic Navigation, Inc. (Littleton)
Philips Nuclear Medicine, Inc.
Philips Medical Systems (Cleveland), Inc.Philips Medical Systems Technologies Ltd.
Roche Diagnostics GMBH
Steris Corporation
Siemens Medical Solutions USA, Inc. Molecular Imaging
Biosense Webster Inc.
Philips Medical Systems
Conmed Corporation
Smiths Medical ASD Inc.
Bio-Rad Laboratories Diagnostics Group
Trinity Biotech USA
Steris Corporation
Chattem Canada
Meridian Bioscience, Inc.
Tornier
Smiths Medical PM, Inc.
Siemens Medical Solutions USA, Inc. Oncology Care Systems
Smiths Medical MD Inc.
Biohorizons Implant Systems, Inc.
Elekta Limited
Elekta Limited
Sigma International, General Medical Apparatus
BHM Medical Inc.
Louisville AFI Diagnostics Inc
Varian Medical Systems, Inc.
I-Flow Corporation
Varian Medical Systems, Inc.
I-Flow Corporation
Biohorizons Implant Systems, Inc.
Meridan Bioscience, Inc.
Terumo Cardiovascular Systems Corp.
Carmel Pharma AB
Siemens Medical Solutions USA, Inc. Molecular Imaging
Philips Medical Systems
Precision Biologic Inc.
Ortho-Clinical Diagnostics
Denka Seiken Co. Ltd
Nova Biomedical Corporation
Dade Behring Inc.
Ambu A/S
Becton Dickinson and Company
Radiometer Medical APS
Hearaeus Kulzer GMBH
Carmel Pharma AB
Siemens Medical Solutions USA, Inc.Oncology Care Systems
Siemens Medical Solutions USA, Inc.Oncology Care Systems
Siemens Med. Solutions USA, Inc.
Disetronic Medical Systems AG
Siemens Medical Solutions Diagnostics
Siemens Medical Solutions USA, Inc.Oncology Care Systems
Meridian Bioscience, Inc.
Biomerieux, Inc
Philips Medical Systems
Baxter Healthcare Corporation
Abbott Diabetes Care Inc.
Boston Scientific Corporation
Medtronic Sofamor Danek USA, Inc
Bard Access Systems, Inc.
Beckman Coulter Inc.
Beckman Coulter Inc.
Baxter Healthcare Corporation
Maquet Cardiopulmonary AG
Elekta Limited
Elekta Limited
Beckman Coulter Inc.
Beckman Coulter Inc.
Beckman Coulter Inc.
Beckman Coulter Inc.
GE Healthcare
Radiometer Medical APS
GE Healthcare
Mini Mitter Company, Inc. A Respironics, Inc. Company
Roche Diagnostics GMBH
GE Medical Systems Kretztechnik GMBH & CO OHG
Carmel Pharma AB
Medtronic Of Canada Ltd
Tyco Healthcare Liebel-Flarsheim Company
Trinity Biotech PLC
Abbott Laboratories Diagnostic Division
Zimmer GMBH
Remel Inc.
Becton Dickson Canada Inc.
Toshiba Medical Systems Corporation
Toshiba Medical Systems Corporation
Terumo Cardiovascular Systems Corp.
Beckman Coulter Inc.
Beckman Coulter Inc.
Walter Lorenz Surgical, Inc. also trading as: Biomet Microfixation
Abbott Laboratories Diagnostic Division
Conmed Corporation
Abbott Laboratories Diagnostic Division
3M ESPE Dental Products
Baxter Healthcare Corporation
Siemens Medical Solutions USA, Inc.Oncology Care Systems
Zimmer Inc.
Respironics Inc.
Siemens Medical Solutions USA, Inc.Oncology Care Systems
Siemens Medical Solutions Diagnostics
Dale Medical Products
Siemens Medical Solutions USA, Inc.Oncology Care Systems
Medtronic Inc.
Zimmer Inc.
Ambu A/S
Philips Medizin Systeme Boeblingen GMBH
Hill-Rom Company, Inc.
Abbott Point Of Care Inc.
GE Healthcare
Becton, Dickinson And Company
Roche Molecular Systems, Inc
GE Healthcare
Becton Dickinson
Bio-Rad Labratories Diagnostics Group
Respironics California, Inc
Roche Diagostics GMBH
Medline Industries Inc
Becton, Dickinson And Company
Welch Allyn Protocol, Inc.
Patterson Dental Canada Inc.
Bard Peripheral Vascular, Inc.
Abbott Laboratories Diagnostic Division
Toshiba Medical Systems Corporation
Porges
Vitatron B.V.
Arjo Hospital Equipment AB
Philips Medical Systems
Sigma International, General Medical Apparatus
Depuy Orthopaedics, Inc.
Radiometer Medical APS
Ethicon Endo-Surgery, LLC
Smith & Nephew, Inc.
Terumo Cardiovascular Systems Corp.
Data Innovations
Terumo Cardiovascular Systems Corp.
Thoratec Corporation
Abbott Laboratories Diagnostic Division
The Anspach Effort Inc.
Beckman Coulter, Inc.
Hudson RCI
Toshiba Medical Systems Corporation
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Instrumentation Laboratory Co.
Conmed Linvatec Endoscopy Division
Orthofab Inc.
Unomedical Ltd MUE
Siemens AG Medical Solutions
Sultan Healthcare
Ambu A/S
Patterson Dental Canada Inc.
Gyrus ACMI, INC.
Masimo Corporation
Span-America Medical Systems Inc.
Gambro BCT, Inc.
Technidata S.A.S.
Advanced Sterilization Products, A Division Of Ethicon
Bio-Rad Laboratories Diagnostic Group
Unomedical SDN BHD
Terumo Cardiovascular Systems Corp.
Terumo Cardiovascular Systems Corp.
Terumo Cardiovascular Systems Corp.
Terumo Cardiovascular Systems Corp.
Terumo Cardiovascular Systems Corp.
Zimmer Inc.
Medtronic Minimed
Baxter Healthcare Corporation
Terumo Cardiovascular Systems Corp.
Becton Dickinson and Company
Becton, Dickinson and Company
Becton Dickinson and Company
Gambro Lundia AB
Gambro Lundia AB
Terumo Cardiovascular Systems Corp.
Diagnostic Systems Laboratories Inc., DSL
Philips Medical Systems (Cleveland), Inc.
Becton Dickinson Diagnostic Instrument Systems
Cardiac Pacemakers Inc. A Wholly Owned Subsidary of Guidant
Balas Dental Supplies Co.
Biomerieux, Inc.
Carestream Health, Inc.
Wallach Surgical Devices Inc.
Bio-Rad Laboratories Diagnostics Group
Diagnostic Systems Laboratories Inc., DSL
Beckman Coulter Inc.
Beckman Coulter Inc.
Smith Medical ASD Inc.
GE OEC Medical Systems Inc. DBA GE Healthcare
GE Healthcare
GE Healthcare
Biomerieux, Inc.
Otho-Clinical Diagnostics
Smiths Medical MD Inc.
Stentor Inc., A Philips Medical Systems Company
Abbott Laboratories Diagnostic Division
Smith & Nephew, Inc., Endoscopy Division
GE OEC Medical Systems Inc. DBA GE Healthcare***************************************GE Healthcare
Philips Medical Systems
Depuy International Ltd.
Bausch & Lomb Inc.
Dade Behring Inc.
Radiometer Medical APS
Siemens AG
Siemens AG
Inverness Medical Professional Diagnostics
AGFA Corporation
Nellcor Puritan Bennett Ireland
Dentalez, Inc.,Stardental Division
GE Healthcare
Bayer Healthcare LLC Subsidiary of Bayer Corporation
Medtronic Inc.
Boston Scientific Corporation
Beckman Coulter, Inc.
GE Healthcare
GE OEC Medical Systems Inc. DBA GE Healthcare
GE OEC Medical Systems Inc. DBA GE Healthcare
Abbott GMBH & CO. K.G.
Smiths Medical ASD, Inc.
Defibtech, LLC
Abbott Laboratories Diagnostic Division
Boston Scientific Corporation
Abbott Laboratories ,Abbott Vascular Inc.
Smiths Medical ASD, Inc.
Gambro Lundia AB
Gambro Lundia AB
Trudell Medical Marketing Limited
Conmed Corporation
Cryocath Technologies Inc.
GE Healthcare
Beckman Coulter, Inc.
Lumenis Ltd.
Medtronic Inc.
Medtronic Inc.
Abbott Molecular Inc.
Alcon Laboratories, Inc.
Smith & Nephew Inc.
Roche Diagnostics GMBH
Teleflex Medical
Becton Dickinson and Company
Medtronic Inc.
Becton Dickinson and Company
Smith and Nephew Inc., Endoscopy Division
Gambro Lundia AB
Gambro Renal Products S.A. DE C.V.
Baxter Healthcare Corporation (Hospital Supply Division)
Baxter Healthcare Corporation
Toshiba Medical Systems Corporation
Biomerieux BV
Maquet Critical Care AB
Siemens Medical Solutions Inc. Oncology Care Systems
Siemens AG
Abbott Laboratories Diagnostic Division
Diagnostica Stago SAS
Cardiac Pacemakers Inc. A Wholly Owned Subsidiary of Guidant
Boston Scientific Corporation
Phillips Medical Systems
Ethicon Endo-Surgery, LLC
Smiths Medical MD Inc.
Immucor Inc.
Walter Lorenz Surgical, Inc. also trading as Biomet Microfixation
Beckman Coulter Inc.
Beckman Coulter Inc.
Beckman Coulter Inc.
Teleflex Medical
Phillips Medical Systems
Streck
Arjo Hospital Equipment AB
Zerusa Limited
Dade Behring Marburg GMBH
Datex-Ohmeda, Inc.
GE Healthcare
GE OEC Medical Systems Inc. DBA GE Healthcare
GE OEC Medical Systems Inc. DBA GE Healthcare
GE Healthcare
GE OEC Medical Systems Inc. DBA GE Healthcare
GE OEC Medical Systems Inc. DBA GE Healthcare
Smith & Nephew Inc.
GE Medical Systems Information Technologies
Conmed Endoscopic Technologies Inc.
Baxter Healthcare Corporation
Stryker Endoscopy
AMG Medical Inc.
Thoratec Corporation
Cardinal Health
T.H.E. Medical
Abbott Laboratories Diagnostic Division
Roche Diagnostics GMBH
American Diagnostica Inc.
Beckman Coulter Inc.
Becton Dickinson and Company
Beckman Coulter Inc.
GE OEC Medical Systems Inc. dba. GE Healthcare
Teleflex Medical
PML Microbiologicals, Inc.
PML Microbiologicals, Inc.
Randox Laboratories Ltd.
Bio-Logic Systems Corp.
Dentsply Tulsa Dental Specialties Trading as Dentsply Endodontics
Angiodynamics, Inc. Also trading as Rita Medical Systems
B. Braun Medical Inc.
Ortho-Clinical Diagnostics
Linvatec Coproration d.b.a. Conmed Linvatec
PML Microbiologicals, Inc.
Lifescan Inc.
Philips Ultrasound
Resmed Limited
Olympus America Inc. (Diagnostic Systems Group)
Diagnostica Stago SAS
Roche Diagnostics GMBH
Philips Medical Systems Nederland B.V.
Abbott Laboratories Diagnostic Division
Roche Diagnostic GMBH
Roche Diagnostic GMBH
Abbott Laboratories Diagnostic Division
Bio-Rad Laboratories
Abbott Laboratories (Ross Products Division)
Biohorizons Impant Systems, Inc.
Biohorizons Impant Systems, Inc.
Sendx Medical Inc.
Electric Mobility Corporation
Fujifilm Corporation
Becton, Dickson and Company
Maquet Critical Care AB
Siemens Medical Solutions USA Inc.
Abbott Laboratories Diagnostic Division
Siemens AG
Abbott Laboratories Diagnostic Division
Philips Medical Systems Nederland B.V.
Sunrise Medical, Respiratory Products Division
Apex Health Care MFG. Inc.
Oxoid Limited
Airox
Beckman Coulter Inc.
Sunrise Mobility Products Division
Beckman Coulter Inc.
Beckman Coulter Inc.
Biosense Webster Inc.
BD Ophthalmic Systems Ltd
Inpeco Spa
Walter Lorenz Surgical, Inc. also trading as: Biomet Microfixation
Abbott Molecular Inc.
Immucor Inc.
Biohorizons Impant Systems, Inc.
Abbott Laboratories Diagnostic Division
Siemens Medical Solutions USA, Inc.
Beckman Coulter, Inc.
Baxter Helthcare Corporation
Cardiac Pacemakers Inc. A Wholly Owned Subsidiary of Guidant
Computerized Medical Systems
Varian Medical Systems, Inc.
Varian Medical Systems, Inc.
Hill-Rom Company, Inc.
Immucor, Inc.
Varian Medical Systems, Inc.
Dentsply Friadent Ceramed
Radiometer Medical APS
Roche Diagnostics GMBH
Sebia
Respironics California, Inc.
Diagnostic Chemicals Limited
Coloplast Corporation
Kerr Corporation
Baxter Healthcare Corporation
Ventana Medical Systems, Inc.
Ondine Biopharma Corporation
Ondine Biopharma Corporation
Walter Lorenz Surgical, Inc.
Becton Dickinson and Company
Ventana Medical Systems, Inc.
Becton Dickinson and Company
Walter Lorenz Surgical, Inc.
Teraklin AG
Varian Medical Systems, Inc.
CIBA Vision Corporation
Medtronic, Inc.
Dade Behring, Inc.
Invacare Corporation
Medtronic, Inc.
Smith & Nephew, Inc.
GE Healthcare Finland OY
Bayer Inc.
Medtronic Emergency Response Systems, Inc.
BHM Medical Inc.
Gambro Industries
Biomerieux SA
Conmed Corporation
Michigan Instruments Inc.
Ortho-Clinical Diagnostics Inc.
Abbott Laboratories Diagnostics Division
Abbott Laboratories Diagnostics Division
Smiths Medical ASD Inc.
Randox Laboratories Ltd.
Innovatek Medical Inc.
Thoratec Corporation
Lifescan Inc.
BHM Medical Inc.
Abbott Laboratories Diagnostcis Division
Teleflex Medical
Medtronic Inc.
Sunrise Medical Canada Inc.
AMD-Ritmed Inc.
Beckman Coulter Inc.
Smith & Nephew Inc.
Teleflex Medical
Micrus Endovascular Corporation
GE Medical Systems, Information Technologies, Inc.
GE Medical Systems, Information Technologies, Inc.
Medtronic, Inc.
Smith & Nephew Inc.
Elekta InstrumentS AB
Diagnostic Products Coporation
Medtronic Emergency Response Systems, Inc.
AGA Medical Corporation
AGFA Corporation
Depuy Orthopaedics, Inc.
Kjaerulff Rehabilitation A/S
Immucor, Inc.
Arjo Limited
Ortho-Clinical Diagnostics
Draeger Medical AG & CO.KG
Conmed Corporation
Calley & Currier
Maquet Critical Care AB
Siemens AG
Siemens AG
Siemens AG
Abbott Laboratories Diagnostics Division
Draeger Medical Inc.
Walter Lorenz Surgical, Inc.
Toshiba Medical Systems Corporation
Toshiba Medical Systems Corporation
Implant Innovations, Inc.
Toshiba Medical Systems Corporation
Dade Behring Inc.
Toshiba Medical Systems Corporation
Toshiba Medical Systems Corporation
Roche Diagnostics GmBH
Balt Extrusion
Dade Behring Inc.
Respironics California, Inc.
Teleflex Medical
Siemens AG
Tornier
Lifescan Inc.
Abbott Laboratories Diagnostic Division
Walter Lorenz Surgical, Inc.
Elekta Instruments AB
Biomerieux, Inc.
Siemens Medical Solutions USA, Inc.
Siemens AG
Siemens AG
Siemens AG
Beckman Coulter, Inc.
Welch Allyn Protocol, Inc.
Abbott Laboratories Diagnostic Division
Diagnostics Systems Laboratories Inc., DSL
Smiths Medical ASD Inc.
Abbott Laboratories Diagnostic Division
Dade Behring Marburg GmBH
Binax Inc.
Immunotech SAS
Innovatek Medical Inc.
Abbott Laboratories Diagnostic Division
Stryker Biotech
Toshiba Medical Systems Corporation
Baxa Corporation
Philips Medical Systems (Cleveland), Inc.
Eyelogic Systems Inc.
Tyco Healthcare Liebel Flarsheim Company
Stryker Medical
Conmed Corporation
Abbott Laboratories Diagnostic Division
Abbott Laboratories Diagnostic Division
Respironics Inc.
Maquet Critical Care AB
Medical Research Laboratories, Inc.A Welch Allyn Company
Depuy Orthopaedics, Inc.
Philips Ultrasound
Philips Medical Systems (Cleveland), Inc.
Therakos, Inc.
Mocrogenics Corporation
Calley & Currier
Lifescan Inc.
Bio Composants Médicaux
Medi-Inn Ltd.
Unomedical A/S
Trudell Medical Marketing Limited
Toshiba Medical Systems Corporation
Bio-Rad Laboratories Diagnostics Group
Ormco Corporation
Friadent GmBH
Becton Dickinson Canada Inc.
Elekta Limited
Elekta Limited
Baxter Healthcare Corporation
Maquet Critical Care AB
Maquet Critical Care AB
Guidant Corporation
Siemens Medical Solutions, Inc. Oncology Care Systems
GE OEC Medical Systems Inc. DBA GE Healthcare
Bio-Rad Laboratories Diagnostics Group
Roche Molecular Systems, Inc.
Synca Marketing Inc.
Abbott Laboratories Diagnostic Division
Guidant Corporation
Boston Scientific Corporation
Siemens AG
Ethicon Inc.
Sorin Group Italia S.R.L.
Cardinal Health 303, Inc.
Draeger Medical Infant Care, Inc.
Baxter Healthcare Corporation
AMG Medical Inc.
AGFA Corporation
Kerr Coporation
GE OEC Medical Systems Inc. DBA GE Healthcare
Datex-Ohmeda, Inc.
GE Healthcare
Epmed Systems
Lifescan Inc.
Baxter Tampa Bay
Conmed Corporation
Dentsply Tulsa Dental
Boston Scientific Corporation
Ossur Engineering Inc.
Disetronic Medical Systems AG
Baxter Healthcare Corporation
Beckman Coulter, Inc.
Midland Manufacturing
Beckman Coulter, Inc.
Bayer Healthcare LLC, Subsidiary of Bayer Corporation
St.Jude Medical
Excelsior Medical Corporation
GC America
Linvatec Corporation D.B.A. Conmed Linvatec
Bayer Healthcare LLC, Subsidiary of Bayer Corporation
Beckman Coulter, Inc.
Dade Behring Inc.
Bard Access Systems A Subsidiary. of C.R. Bard Inc.
Siemens Medical Solutions USA, Inc. Molecular Imaging
Gambro Renal Products S.A. De C.V.
Sunrise Medical, Respiratory Products Division
Gaymar Industries Inc.
FHC, Inc.
Sirona Dental Systems GMBH
Baxter Healthcare Corporation
Advance Medical Optics, Inc.
Siemens AG
Siemens AG
Fisher and Paykel Healthcare
Western / Scott Fetzer Co.
Elekta Instrument AB
Siemens AG
Roche Diagnostics Corporation
Baxter Healthcare Corporation
The Anspach Effort Inc.
Carl Zeiss Meditech AG
Beckman Coulter Inc.
Dade Berhing Inc.
Dade Berhing Inc.
Boston Scientific Corporation
Ferno, Division of Ferno-Washington Inc.
Hoya Conbio
Elekta Instrument AB
Medtronic Emergency Response Systems
GE Healthcare
Hamilton Co.
Kerr Corporation
Dentsply Tulsa Dental
Abbott Laboratories Diagnostic Division
Smith & Nephew, Inc., Orthopaedic Division
Arizant Healthcare Inc.
Varian Medical Systems
Hobbs Medical , Inc.
Smith & Nephew, Inc., Orthopaedic Division
Fresenius Medical Care
Boston Scientific Corporation
Stryker Instruments
Linvatec Corporation D.B.A. Conmed Linvatec
Boston Scientific Corporation
Beckman Coulter Inc.
GE Healthcare
Beckman Coulter Inc.
Medtronic Inc.
Phadia AB
Ethicon Inc., A Johnson & Johnson Company
Card Guard Scientific Survival Inc.
Kinetic Concepts Inc.
Arizant Healthcare Inc.
Waverleyglen Systems Ltd.
Becton Dickinson and Company
Becton Dickinson and Company
Bayer Healthcare LLC Subsidiary of Bayer Corporation
Bayer Healthcare LLC Subsidiary of Bayer Corporation
GE Healthcare
AGA Medical Corporation
Fuji Film Medical Systems USA. Inc.
Biomerieux SA
Biomerieux SA
C.R. Bard , Inc. Bard Urological Division
Medtronic Inc.
Bio-Rad Laboratories Diagnostics Group
Immucor Inc.
Boston Scientific Corporation
United States Surgical, a Division of Tyco Healthcare Group
Baxter Healthcare Corporation
AGFA Corporation
Valleylab, A Division of Tyco Healthcare Group LP
Kyphon Inc.
Lifescan Inc.
Ballard Medical Products
Boston Scientific Corporation
Synthes (Canada) Ltd.
Abbott Laboratories Diagnostic Division
Stentor Inc., A Philips Medical Systems Company
Abbott Laboratories Diagnostic Division
Philips Medical Systems Nederland B.V.
Philips Medical Systems
Abbott Laboratories Diagnostic Division
Microline Inc.
Philips Medical Systems Nederland B.V.
Siemens AG
Kaltenbach & Voigt GMBH
Stryker Endoscopy
Argon Medical Devices Inc.
Gambro Dasco S.P.A.
I-Stat Corporation
Viasys Healthcare, Inc., Neurocare Group, Nicolet Biomedical Division
Dentsply Tulsa Dental
Eagle Vision Inc.
Baxter Healthcare Corporation
Siemens AG
Siemens AG
Siemens AG
Philips Medical Systems Nederland B.V.
Abbott Laboratories Diagnostic Division
Baxter Healthcare Corporation
Stryker Medical Quebec LP
Boston Scientific Corporation
Abbott Laboratories Diagnostic Division
Gambro Dasco S.P.A.
Zimmer
Canadian Blood Services
Stryker Endoscopy
Baxter Healthcare Corporation
Beckman Coulter Inc.
Cardiomed Supplies Inc.
Boston Scientific Corporation
Baxter Healthcare Corporation
Valleylab, A Division of Tyco Healthcare Group LP.
Siemens AG Medical Solutions
Baxter Healthcare Corporation
AGFA Corporation
Abbott Laboratories Diagnostic Division
Abbott Laboratories Diagnostic Division
Abbott Laboratories Diagnostic Division
Biomerieux, Inc.
Becton Dickinson Diagnostic Instrument Systems.
Becton Dickinson Diagnostic Instrument Systems.
Linvatec Corporation D.B.A. Conmed Linvatec
Sendx Medical Inc.
Alsius Corporation
Stryker Instruments
Beckman Coulter Inc.
Western Medica
Hamilton Medical Inc.
Cardiac Pacemakers Inc. A Wholly Owned Subsidiary of Guidant
Stryker Instruments
Medtronic Emergency Response Systems
Medtronic Emergency Response Systems
Medtronic Emergency Response Systems
Bio-Rad Laboratories Diagnostics Group
Abbott Laboratories Diagnostic Division
Ortho-Clinical Diagnostics Inc.
Arizant Healthcare Inc.
Velocimed Inc.
Medisystems Corporation
Linvatec Corporation D.B.A. Conmed Linvatec
Stryker Trauma GMBH
AGFA Corporation
AGFA Corporation
Siemens AG
Siemens AG
Siemens AG
Beckman Coulter Inc.
Beckman Coulter Inc.
FHC, Inc.
Alcon Laboratories, Inc.
Medtronic Emergency Response Systems
Bio-Rad Laboratories Diagnostics
Cardinal Health 303, Inc.
Stellar Pharmaceuticals Inc.
TNCO, Inc.
Advanced Sterilization Products
Beckman Coulter Inc.
Beckman Coulter Inc.
Varian Medical Systems, Inc.
Cook Incorporated, A Cook Group Company
Becton Dickinson and Company
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Davol Inc., Subsidiary of C.R. Bard Inc.
William Cook Europe A/S, A Cook Group[ Company
Body Health Inc.
Roche Diagnostics GMBH
Boston Scientific Corporation
Hocoma AG
Wilson Cook Medical Inc., A Cook Group Company
Gambro Industries
Medex Inc.
Ethicon Inc., A Johnson & Johnson Company
Ortho-Clinical Diagnostics
Boston Scientific Corporation
Abbott Laboratories Diagnostic Division
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Beckman Coulter Inc.
Dakocytomation Ltd.
Radiometer Medical APS
MTRE Advanced Technologies Ltd.
Becton Dickinson and Company
Beckman Coulter Inc.
Beckman Coulter Inc.
Radiometer Medical APS
Dade Behring, Inc.
E-Z-EM Inc.
Diagnostic Products Corp. (DPC)
Philips Medical Systems Nederland B.V
Philips Medical Systems
Hamilton Co.
HeartSine Technologies, Ltd.
Wilson Cook Medical Inc., A Cook Group Company
Merit Medical Systems Inc.
Smiths Medical International Ltd.
Becton Dickinson
Baxter Healthcare Corporation
GE Healthcare
Beckman Coulter Inc.
Beckman Coulter Inc.
Becton Dickinson Company
Dade Behring Marburg GMBH
Instrumentation Laboratory Co.
GE Healthcare
Vapotherm, Inc.
Abbott Laboratories Diagnostic Division
Spacelabs Medical Inc.
Interventional Technologies Europe Ltd.
Canadian Blood Services
Bausch & Lomb, Inc.
Omoron Healthcare Inc.
Lifescan Inc.
Bio-Rad Laboratories
Boston Scientific Corporation
Stryker Endoscopy
Boston Scientific Corporation (From A to J)********************Catheter Innovations (K to L)
Baxter Corporation (A)*******************Baxter Healthcare Corporation (B to Q)
Philips Medical Systems (Cleveland), Inc.
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Baxter Corporation (A to C)*******************Baxter Healthcare Corporation (D to G)
Hospira Inc.
Siemens Aktiengesellschaft
Siemens Aktiengesellschaft
Beckman Coulter, Inc.
Abbott Laboratories Diagnostic Division
Ethicon Endo-Surgery, Inc. A Johnson & Johnson Company
CIBA Vision Canada Inc., Sterile Manufacturing
Abbott Laboratories Diagnostic Division
Abbott Laboratories Diagnostics Division
Beckman Coulter, Inc.
Bard Peripheral Vascular Division
Becton Dickinson and Company
Becton Dickinson
Dade Behring Marburg GMBH
Spacelabs Medical Inc.
I-Stat Corporation
Abbott Laboratories Diagnostic Division
Abbott Laboratories Diagnostics Division
Abbott Laboratories Diagnostics Division
Abbott Laboratories Diagnostic Division
Dade Behring Marburg GMBH
Beckman Coulter, Inc.
Diamed AG
Dade Behring, Inc.
Dolomite AB
Heartport, Inc.
Philips Medical Systems
Dakocytomation Ltd.
Angel Accessibility Solutions Limited
Tung Keng Enterprise Co. Ltd.
Eastman Kodak Company
Hospira Inc.
Bio-Rad Laboratories Diagnostics Group
Bio-Rad Laboratories Diagnostics Group
Biomerieux Inc.
SYVA Company , Dade Behring Inc.
Medex Inc.
Medrad Inc.
Sorin Group Deutschland GMBH
Medtronic Mexic,S. DE R.L. DE C.V.
Maquet Critical Care AB
Beckman Coulter, Inc.
Datex-Ohmeda
Chad Therapeutics Inc.
Maquet Critical Care AB
Ohmeda Medical
Diagnostica Stago
Diagnostica Stago
Medrad Inc.
Beckman Coulter, Inc.
Baxter Healthcare Corporation
Siemens Aktiengesellschaft
Vail Products, Inc.
Varian Medical System Imaging Laboratory GMBH
Ortho-Clinical Diagnostics, Inc.
Ortho-Clinical Diagnostics Inc.
Ortho-Clinical Diagnostics
3M Health Care
Baxter Healthcare Corporation
Vapotherm, Inc.
Roche Diagnoctics GMBH
Varian Medical System, Inc.
Varian Medical System, Inc.
Varian Medical System, Inc.
EV3 Inc.
Dade Behring Marburg GMBH
Implant Innovations, Inc.
Corin Medical Limited
Linvatec Corporation
Linvatec Corporation
Dade Behring Marburg GMBH
Synthes(Canada) Ltd.
Beckman Coulter Inc.
Draeger Medical, Inc.
Nichols Institute Diagnostics
GE Healthcare
Lifescan Inc.
Beckman Coulter Inc.
Electric Mobility Corporation
Ortho-Clinical Diagnostics Inc.
Ortho-Clinical Diagnostics Inc.
Abbott Laboratories Diagnostic Division
Varian Medical System, Inc.
Cardinal Health
Nichols Institute Diagnostics
Olympus Winter & IBE GMBH
Bio-Rad Laboratories Diagnostics Group
Misys Healthcare Systems Inc.
Esaote S.P.A
Varian Medical System Inc.
Varian Medical System Inc.
Siemens Aktiengesellschaft
Biomerieux Inc.
Angiomed GMBH & CO Medizintechnik KG Subsidiary of C.R. Bard Inc.
Boston Scientific Corporation
Abbott Laboratories Medisense Prod.
Cardiac Pacemakers Inc.A Wholly Owned Subsidiary of Guidant
Siemens Aktiengesellschaft
Dade Behring Marburg GMBH
Infectio Diagnostics (I.D.I) Inc.
Boston Scientific Meditech
Beckman Coulter Inc.
Roche Diagnostics GMBH
Dade Behring Marburg GMBH
AGA Medical Corporation
Streck
Dade Behring Inc.
Tosoh Corporation
Beckman Coulter Inc.
Bio-Rad Laboratories, Inc.
Bio-Rad Laboratories Diagnostics Group
Biomerieux Inc.
Oscor Inc.
Implant Innovations, Inc.
Medtronic Inc.
Dade Behring International, Inc.
Immucor, Inc.
Siemens Canada Limited
B.Braun Medical Inc.
Biosense Webster, A Johnson & Johnson Company
United States Surgical, A Div. of Tyco Health Care Group
General Electric Medical System
Biomerieux Inc.
Zimmer Trabecular Metal Technology, Inc.
Valleylab, A Div.of Tyco Healthcare Group LP
Siemens Medical System Inc.
Immunotech
Boehringer Laboratories, Inc.
Beckman Coulter Inc.
Instrumentation Laboratory Co.
Keir Surgical Ltd.
Philips Medical Systems (Cleveland), Inc.
Immucor Inc.
Alsius Corporation
Beckman Coulter Inc.
Varian Medical Systems, Inc.
Beckman Coulter Inc.
Beckman Coulter Inc.
Beckman Coulter Inc.
Beckman Coulter Inc.
Medtronic A/S
Becton Dickinson Infusion Therapy Systems Inc.
Becton Dickinson and Company
Baxter Healthcare Corporation
Depuy Orthopaedics, Inc.
Philips Medical Systems
Cardinal Health
Ohmeda Medical
Biomerieux, Inc.
Philips Medical Systems
Biomerieux, Inc.
Dade Behring Canada, Inc.
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Carroll Healthcare Inc.
Hill-Rom Company, Inc.
Becton Dickinson and Company
Immucor Inc.
Beckman Coulter Inc.
Beckman Coulter Inc.
Baxter Corporation
Diamed AG
Medtronic Inc.
Cardinal Health
Varian Medical Systems Inc.
Lifescan Inc.
Beckman Coulter Inc.
Boston Scientific Ltd.
Heartport Inc.
Philips Electronics Ltd.
CTI Pet Systems Inc.
Lifescan Inc.
Arrow Medical Products, Ltd.
Medrad Inc.
Ormco Corporation
Varian Medical Systems
Arizant Healthcare Inc.
Smith & Nephew, Inc. , Orthopaedic Division
Boston Scientific Microvasive
Puritan-Bennett Corporation
Smith & Nephew, Inc. , Orthopaedic Division
Ormco Corporation
Baxter Healthcare Corporation
Medline Industries Inc.
Cardinal Health
Medline Industries Inc.
Wilson Cook Medical Inc.A Cook Group Company
Siemens Aktiengesellschaft
Siemens Aktiengesellschaft
Balt Extrusion
Siemens Medical Solutions, Inc. Oncology Care Systems
                  Recall Start Recall Number ClassificationCatalog or Serial #
Recall Posting Date            Date Hazard       Model or      Lot #
           8/30/2010 11/2/2009 51661      Type I                 A) 8308330B) A1967, A2399C) A1951
                                                      A) 385102B) 385150, 385151C) 385164              D) 8238450,
                                                                                               D) 383530, 383531
           8/30/2010 8/2/2010 55961       Type II                22225C) 22225
                                                      A) 22225B) A) 345158910B) 345158910C) 345158910
           8/30/2010   7/2/2010 55962     Type II    TD-SYN-01N/A
           8/30/2010   7/2/2010 55963     Type II               A) N/AB) N/A
                                                     A) TD-LIS-01B) TD-SYN-01
           8/30/2010   8/3/2010 55964     Type III            159526
                                                     03314847190
           8/30/2010 7/26/2010 55983      Type II    A48617     009046, 010202, 829586, 909837, 914557, 915628, 917
           8/30/2010   8/3/2010 55984     Type II    472525     M911428, M911519
           8/30/2010   8/4/2010 56025     Type II    004942-903186540FC
           8/30/2010 7/27/2010 55981      Type II    T-72       >100 Numbers, Contact Manufacturer
           8/30/2010   8/4/2010 56012     Type II    7115-0007 MJK68N
           8/30/2010   8/6/2010 56047     Type III             A) 08H00-01
                                                     A) 01H01-01B)N/AB) N/A
           8/30/2010 8/10/2010 56054      Type II    2810001EX All lots
           8/30/2010 7/15/2010 56013      Type II    M1657B     >100 Numbers, Contact Manufacturer
           8/30/2010   8/5/2010 56046     Type II              09355012
                                                     0575-100-000
           8/30/2010   8/4/2010 56051     Type II             A) 887069, 905131, 909364, 919774, 926904, 933512, 9
                                                     A) SNE30CRXXXB) SEN30EAXXX, SEN30MEXXX
           8/30/2010   8/6/2010 56041     Type III   1.17E+10 155674, 157677
           8/30/2010   7/7/2010 56053     Type II              A) All lots B) All
                                                     A) 3666794B) 04800842190 lots
           8/30/2010 7/12/2010 56084      Type II             >100 Numbers, Contact Manufacturer
                                                     M3535A, M3536A
           8/30/2010 8/10/2010 56101      Type II    6801740    Generation 2, 3 & 4
           8/30/2010 7/16/2010 55784      Type II    70620    01S15239
           8/30/2010 4/14/2010 54156      Type III   EX-10552 All lots
           8/30/2010   7/5/2010 55559     Type III             A) 49471033, 50694033, 51071033, 51628033, 5226003
                                                     A) 07566733B) 07566733C) 07566733
           8/30/2010   8/9/2010 56099     Type II    DSL-6600 100115A, 100319A, 100409A, 100430A, 991225, 99169
           8/30/2010 8/10/2010 56130      Type II              740545H, 680295H, 770878H
                                                     13261, 13273
           8/30/2010 8/10/2010 56139      Type II    15970      All Serial Numbers
           8/30/2010   8/4/2010 56143     Type II    7205962    >10 Numbers, Contact Manufacturer
           8/30/2010   8/2/2010 55982     Type III   06F13-01 B09342, B09154
           8/30/2010   8/9/2010 56052     Type III   DR10, DR510-1209, 05-1209
           8/30/2010   8/2/2010 56160     Type III   N/A        B006X641
           8/30/2010 8/12/2010 56170      Type I               A) 62837701B) 62838001C) 62841101
                                                     A) 04912551190B) 04912497190C) 05077753190
           8/30/2010 6/25/2010 55469      Type II    1.17E+10 15418301, 15418305
           8/30/2010 5/11/2010 54721      Type III             A) >10 Numbers, Contact Manufacturer B) >10 Numbers
                                                     A) H74939135152010, H74939135202010, H74939135203010, H74
           8/30/2010 8/11/2010 56152      Type III             A) 2473, 2559, 2618, 3235, 3236, 3376, 2459, 2616, 329
                                                     A) 1940035B) 8139789
           8/30/2010   8/9/2010 56165     Type II    442640     All non-expired lots
         2010/06/21 ######## 54614        Type III             SI135828G8
                                                     0998-00-3023-XX
         2010/06/21 ######## 54812        Type II    447650     T908069, T908104, T909110
         2010/06/21 ######## 54894        Type II    N/A        Release 4.50.00 & Higher
         2010/06/21 ######## 54897        Type II    N/A        Release 2.1.0 & Higher
         2010/06/21 ######## 54873        Type I               A) 505-2002
                                                     A) 505-2001B)09100002, 09120011, 10010007, 10030060, 0907004
         2010/06/21 ######## 54899        Type I     FL-601-97 100701
         2010/06/21 ######## 54626        Type III              N09315,
                                                     04J50-01, 04J50-02 N09323, N09323A, N09346A, S09347, S09354
2010/06/21 ######## 54496       Type II               A) All lots S209B) S403, lots D) S503,
                                           A) S201, S206, S208,B) All lots C) AllS404C) All lotsS504, S508D) S
2010/06/21 ######## 54858       Type II    78050      All lots (Expiration dating from May 2010 to March 2015)
2010/06/21 ######## 54921       Type II               A) >10 45-310, 45-315, 45-320, 45-340, 45-360B) 45-21
                                           A) 45-303, 45-305, Numbers, Contact Manufacturer B) >100 Numbe
2010/06/21 ######## 54852       Type II    1153       1006320, 1012481
2010/06/21 ######## 54886       Type II            Y01
                                           GM11002420 to E19
2010/06/21 ######## 54811       Type II             A) L2SUBMC) L2SUBMD) L2SUBM
                                           A) L2SUBMB) 282, 283B) 282, 283C) 282, 283D) 282, 283
2010/06/21 ######## 54929       Type II    150-FT-Q 96501, 96502
2010/06/21 ######## 54935       Type I               Beginning
                                           71440116, 71440118 with 08MM through and including 09HM
2010/06/21 ######## 54061       Type III   Elite      >10 Numbers, Contact Manufacturer
2010/06/21 ######## 54809       Type II              A) B10C-02839, B10C-02824, B10C-03286B) A10C-050
                                           A) 861304B) M5066A
2010/06/21 ######## 53133       Type II               A) 102788, 104449, 104679B) 7086966, 8047402, 7086
                                           A) 0594B) 58230
2010/06/21 ######## 54934       Type III   1L76-25    80162M100
2010/06/21 ######## 55074       Type II    MTS213784>10 Numbers, Contact Manufacturer
2010/06/21 ######## 55075       Type II    MTS213784>10 Numbers, Contact Manufacturer
2010/06/21 ######## 54480       Type III               3926, 3927, 3930, 3931, 3932, 3933,
                                           3922, 3925,>100 Numbers, Contact Manufacturer 3935, 3936
2010/06/21 ######## 55065       Type II             >10 SDS-CTP-SPK
                                           SDS-CTP-QFT, Numbers, Contact Manufacturer
2010/06/21 ######## 55073       Type II    SSA-790A >10 Numbers, Contact Manufacturer
2010/03/29   ########   52934   Type II                >10
                                           C0R36, C0R37 Numbers, Contact Manufacturer
2010/03/29   ########   52986   Type II                A) FD10/10B) Allura XPER FD10/10C) 722016D) 722043
                                           A) Allura XPERSN085257, SN085194, SN09004890B) SN074546, SN
2010/03/29   ########   53041   Type II    M4741A, M4742A, M4743A, M4744A
                                                       0908, 1008, 1108, 1208
2010/03/29   ########   53044   Type II              A) All lots
                                           A) 286600B) 378600 B) All lots
2010/03/29   ########   53049   Type III             A) 2009XXXXXXXB) 2009XXXXXXX
                                           A) 450E0-E1, 450E0-F1, 450T0-E1, 450T0-F1B) 45ME0-E1, 45ME0
2010/03/29   ########   53131   Type II               A) >10 Numbers, Contact ManufacturerB) >10 Numbe
                                           A) 33340, 33345, A78803B) 33340, 33345, A78803C) 33340, 33345
2010/03/29   ######## 53200     Type III             A) >10 Numbers, Contact Manufacturer B) 11776223-3
                                           A) 03289788-190B) 11731629-322C) 03045838-122D)>10 Numbers
2010/03/29   ########   53200   Type III             A) >10 Numbers, Contact Manufacturer B) 05118921-1
                                           A) 11821598-322B) 03314847-190C) 04842464-190D)>10 Numbers
2010/03/29   ########   53207   Type III              A) SYS01048,
                                           A) N/AB) N/AC) N/AD) N/ASYS01044, SYS01046, SYS00921, SYS0
2010/03/29   ########   53209   Type III             A) 2039, 2139, 2214, 2239, 2247, 2255, 2537B)
                                           A) 10093962 B) 10093961C) 5904086D) 5902783, 5902791>10 Num
2010/03/29   ########   53210   Type II               33550C) 33600D) 33550E) 33600F) 33550
                                           A) 33600B) A) N/AB) N/AC) N/AD) N/AE) N/AF) N/A
2010/03/29   ########   53213   Type III             A) M901536, M904505B) M908383, M908768
                                           A) 469170B) 467905
2010/03/29   ########   53235   Type II              45847
                                           36 101 3493
2010/03/29   ########   53236   Type III              to 010-2, STO1-020-1 to 020-2, STO1-030-1, STO1-050
                                           STO1-010-1B420702032 to 0402110097
2010/03/29   ########   53237   Type III   BF578      004876 to 005161
2010/03/29   ########   53281   Type III   10380063 65 to 120
2010/03/29   ########   53292   Type II    1844       2092840, 2093243
2010/03/29   ########   53297   Type III             A) 532-5035
                                           A) 532-5040B)N/AB) N/A
2010/03/29   ########   53306   Type II              A) 010-894
                                           A) 010-665B) 2988755, 2966726, 2983464B)       2963593009, 29909
2010/03/29   ########   53307   Type III   2.82E+10 470266 to 483672
2010/03/29   ########   53314   Type III   47290-10 012 666804
2010/03/29   ########   53325   Type III             >10 Numbers,
                                           1A8502, 1A8503, 1A8504 Contact Manufacturer
2010/03/29   ########   53326   Type I               A) >10 6051-0000-192B) Manufacturer B) >100 Numbe
                                           A) 6051-0000-190, Numbers, Contact 6051-0000-191, 6051-0000-19
2010/03/29   ########   53327   Type III   KC120      9GM001
2010/03/29   ########   53331   Type II    N/A        Part # N69AD, Lot # 200720
2010/03/29   ########   53348   Type II              A) N/AB) N/AC) N/AD) N/A
                                           A) 72714-2001B) 72714-2101C) 72714-2124D) 72714-2501
2010/03/29   ########   53377   Type II              091002, 091106, 091013, 091017, 090919,
                                           623400, 623401Y, 623450, 623451Y, 623701, 623702 091120, 09
2010/03/29   ########   53386   Type III              010/529773, 010/576600, 010/617620, 010/650982, 0
                                           45040-4, 45041-4
2010/03/29   ########   53127   Type II               1806-6151, 1806-6162
                                           1806-6150, Brochure Lot # A3507, B2208, Device Lot # All
2010/03/29   ########   53313   Type II    7211008    32109Y
2010/03/29   ########   53388   Type III              A) 3284B) 3284
                                           A) 8485971B) 4504200
2010/03/29   ########   53439   Type III   10032746 114348, 114388
2010/03/29   ########   53447   Type III   N/A        MOSAIQ 1.60W (all packs), MOSAIQ 2.00T2 (all packs)
2010/03/29   ########   53028   Type II    N/A        102366, 102783, 130108, 103492, 103839, 104398, 10
2010/03/29   ########   53374   Type III              T3312C) T6940D) T6945E) T6950F) 296761-1, 297437-
                                           A) T3311B) A) 298413-1, 299272-1B) 296157-1,T6955
2010/03/29   ########   53424   Type II                RMGB1800, Contact Manufacturer
                                           RMGB1400,>10 Numbers,RMGB2000, RMGB2400
2010/03/29   ########   53440   Type III              A) 111843, 111922, 111923, 112267,
                                           A) 5936518B) 8653771C) 10032746, 10032747 10134, 111786, 1
2010/03/29   ########   53353   Type II    0087000 N/A
2010/03/29   ########   53141   Type II    SSH4       Start # 00100. Ending # 001679
2010/03/29   ########   53442   Type III             >10 Numbers, Contact Manufacturer
                                           6C30-20, 6C30-25
2010/03/29   ########   53483   Type III   47290-10 011 484916, 011 536590, 012 625731
2010/03/29   ########   53486   Type III             A) 036 616504, 036 656155, 025 663049B) 034 625679
                                           A) 78000-10, 78001-10, 78700-10B) 78100-10
2010/03/29   ########   53487   Type III             0902025,
                                           PBRIC, PGRIC, PYRIC 0900980, 0902585, 0903089, 0901112
2010/03/29   ########   53493   Type II    101264    S/N: 10169, 10037
2010/03/29   ########   53489   Type III             S/N: B0428102135 - B0430207104
                                           Harmony 500 and 700
2010/03/29   ########   52535   Type I               A) >10 Numbers, Contact 4515185F, 4515225F, 45152
                                           A) 4520185F, 4520225F, 4520245FB)Manufacturer B) >10 Numbers
2010/03/29   ########   52174   Type II              >10 Numbers, Contact
                                           4500185F, 4500225F, 4500245F Manufacturer
2010/03/29   ########   53228   Type II    16-462     0012934317, 0012934318
2010/03/29   ########   52123   Type I     CM0225B 762134, 793640, 762133, 819692, 819693
2010/03/29   ########   53553   Type II               A) >100 Numbers, 9998-03-643, 9998-03-845, 9998-03
                                           A) 9998-03-239, 9998-03-441,Contact ManufacturerB) >100 Numb
2010/03/29   ########   53558   Type II    1530-154 200903XH, 200904BK, 200911OJ
2009/10/12   ########   50725   Type III   N/A        A090504Z
2009/10/12   ########   50774   Type II    N/A        Version 2.1.0
2009/10/12   ########   50850   Type II    900MR800 All Lot Numbers
2009/10/12   ########   49927   Type II              A) >10 Numbers, Contact Manufacturer
                                           A) S30321ZKB) 5183859-3, 5183859-4, 5183859-5 B) S/N'S A8177
2009/10/12   ######## 50779     Type III   Workcell   N/A
2009/10/12   ######## 50863     Type III   UA233      154107
2009/10/12   ######## 50823     Type II               A) N/AB) N/A
                                           A) LSP42, LSP46, LSP47M, LSP48B) LASST
2009/10/12   ######## 50793     Type II    10041461 200252, 200288, 200334, 200926, 200979, 200995
2009/10/12   ######## 50811     Type II               A) >100 Numbers, Contact ManufacturerB) >100 Numbe
                                           A) 18-251, 18-252, 18-253B) 18-285, 18-286, 18-288, 18-289, 18-29
2009/10/12   ######## 50941     Type II                >100
                                           18-257, 18-259 Numbers, Contact Manufacturer
2009/10/12   ######## 50914     Type III   1077-1     038K6170
2009/10/12   ######## 50938     Type II              A) >10 Numbers, Contact Manufacturer B) >100 1027-0
                                           A) 0737-000-000, 0738-000-000B) 1007-000-000 (SM104)C)Numbe
2009/10/12   ######## 48011     Type III            12045170, 12070363, 12073173, 12054585, 12054587
                                           H74937911515900, H74937911614900, H74937911715900, H7493
2009/10/12   ######## 50864     Type III   YG18568 >10 Numbers, Contact Manufacturer
2009/10/12   ######## 50931     Type III   GTOB2004212709123
2009/10/12   ######## 50961     Type III   360500     08D22-156-32913, 08D22-157
2009/10/12   ######## 50964     Type III   1302-55M 55QJ
2009/10/12   ######## 47780     Type II              A) 5131070B) 2259973-3, 2259976, 2259988, S3918KD
                                           A) 2259988-2, >10 Numbers, Contact Manufacturer B) >100 Numbe
2009/10/12   ######## 50981     Type II                04.808.002, 04.808.003, 04.808.004, 04.808.005, 04.80
                                           04.808.001,All Lot Numbers
2009/10/26   ######## 50797     Type II               LCRCMC) LCRCMD) LCRCME) L2KCRP2F) LCRCMG) LCRC
                                           A) LCRCMB)A) 022L, 025LB) 022L, 025LC) 022L, 025LD) 022L, 025LE
2009/10/26   ########   51015   Type II    50300700 0905220164, 0906240184
2009/10/26   ########   51026   Type III   IS2000    N/A
2009/10/26   ########   51040   Type II    164275    KN10, KP08, LA12, LC16, LE15
2009/10/26   ########   51025   Type II              M1091335, M1091365
                                           M1091316,N/A
2009/10/26   ########   51053   Type II    1180.360AON/A
2009/10/26   ########   50401   Type II    537702    N/A
2009/10/26   ########   50403   Type II              A) BBB97037, BBB97730, BBB97731, BBB97734, BBB98
                                           A) PRO5100MB) PRO5200MC) PRO5300MD) PRO5400ME) PRO620
2009/10/26   ########   48621   Type II    N/A       687218
2009/10/26   ########   50977   Type III            >10 Numbers, Contact ARD 567910901, ARD 5679109
                                           ARD 567801093, ARD 567801094,Manufacturer
2009/10/26   ########   50979   Type III              K7022C) 10445904D) 10445888
                                           A) K7058B) A) 07310MA, 08029MA, 08252MA, 08336MAB) 07311M
2009/10/26   ########   51040   Type II    164275    KN10, KP08, LA12, LC16, LE15
2009/10/26   ########   51117   Type I     ENGEN     JCT20Q3J
2009/10/26   ########   51125   Type III   600-4000 080901333, 080902356, 070981416, 060971299, 06097
2009/10/26   ########   51016   Type III   K1021     09187AA
2009/10/26   ########   51017   Type III   KF01025   8.11E+08
2009/10/26   ########   51120   Type II              >10
                                           0702-001-000 Numbers, Contact Manufacturer
2009/11/09   ########   50973   Type III   13BX      96158DB
2009/11/09   ########   51118   Type II    EC1001    >10 Numbers, Contact Manufacturer
2009/11/09   ########   49248   Type III   N/A       RL-1094
2009/11/09   ########   51119   Type II             >100 Numbers, M001171100, M001171120
                                           M001171060, M001171080,Contact Manufacturer
2009/11/09   ########   51151   Type I     724-E     03-25
2009/11/09   ########   51184   Type II              >10 Numbers, Contact Manufacturer
                                           6470114, 6470115, 6470116, 6470117, 6470118
2009/11/09   ######## 50598     Type II               A) > 100 Numbers, Contact ManufacturerB)
                                           A) N/AB) N/AC) N/AD) N/AE) N/AF) N/AG) N/AH) N/A > 10 Numbe
2009/11/09   ########   50810   Type II            >100 Numbers, Contact Manufacturer
                                           M001761101, M001761122, M001761141, M001761162, M00176
2009/11/09   ########   50980   Type III   56077943 00001717, 00001719
2009/11/09   ########   51219   Type II              >10 Numbers, Contact Manufacturer
                                           10042, 10043, 10044, 10046, 10047, 10048, 10050, 10051, 10052,
2009/11/09   ########   51220   Type III   104 96 279 1225, 1532, 1533
2009/11/09   ########   51221   Type III   075 020 29 14630
2009/11/09   ########   50850   N/A        N/A       N/A
2009/11/09   ########   51204   Type II    30-1014   011668, 011970
2009/11/09   ########   51212   Type II              >10 Numbers, Contact REF-900509-5
                                           REF-900000-900002, REF-900034, Manufacturer
2009/11/09   ########   51218   Type III   OUBD23    537675, 537682
2009/11/09   ########   51241   Type II    N/A       Release 4.3.0 & Higher
2009/11/09   ########   51249   Type III             A) 112267, 10134B) 114573, 113469
                                           A) 05936518B) 10032746
2009/11/09   ########   51262   Type III   1000855   >100 Numbers, Contact Manufacturer
2009/11/09   ########   51278   Type II    N/A       123574, 123612, 123620
2009/11/09   ########   48348   Type III   100 90 480 92241, 95243, 93477, 95071, 95248
2009/11/09   ########   51227   Type III             A) S/N D00229B) S/N D04842, D05589 & D50233
                                           A) H48651PTB) H48661N
2009/11/09   ########   51245   Type III   71642220 >10 Numbers, Contact Manufacturer
2009/11/09   ########   51246   Type III             A) 10024B) 10040
                                           A) 08162807B) 08162815
2009/11/09   ########   51309   Type III             All IW930, IW932, IW934, IW950,IW980, WITH SUFFIX
                                           IW910, IW920,Infant Warmers in Canada.
2009/11/09   ########   51330   Type II    N/A       >10 Numbers, Contact Manufacturer
2009/11/09   ########   51331   Type III   9015      W72407
2009/11/09   ########   50942   Type I               For product
                                           72201714, 72201716 code 72201714: (L) 50278012For product c
2009/11/09   ########   51091   Type II                A) >10 Numbers, 756008025, 756010025, >10 Number
                                           A) 716084020B) 756007025, Contact Manufacturer B) 756012025,
2009/11/09   ########   50934   Type II                A) >10 180-32000-07, 180-32000-22
                                           A) 180-32040-22B)Numbers, Contact Manufacturer B) >10 Number
2009/11/09   ########   50937   Type III   5.37E+09 DK146-01, DK149-01
2009/11/09   ########   51194   Type II                A) >10 04490843190
                                           A) 03800504190B)Numbers, Contact Manufacturer B) >10 Number
2009/11/09   ########   51217   Type III   48-0600 480109
2009/11/09   ########   51327   Type II    MX0100 >10 Numbers, Contact Manufacturer
2009/11/09   ########   51383   Type III               Suffix > Warmers in Canada.
                                           Series With All InfantIW910, IW920, IW930, IW932, IW934, IW950,
2009/11/09   ########   51252   Type III               426-0246
                                           4226-0228, N/A
2009/11/23   ########   47672   Type III               A
                                           S98-1925-2Hll lots are affected
2009/11/23   ########   51366   Type III               1145687
                                           47290-10, 47291-10
2009/11/23   ########   51369   Type III   7114-0108 L06MT04447, L08ET19936
2009/11/23   ########   51408   Type III             60594607
                                           00-2357-009-06
2009/11/23   ########   51428   Type II               J318H
                                           A) Z316HB)A) ACM008B) ACM473
2009/11/23   ########   51459   Type III             >10
                                           20300, 20301 Numbers, Contact Manufacturer
2009/11/23   ######## 48250     Type II    418779-010, APRSRVR16=XXX, CICV3APRO=XXX, CICV3APRO=
                                                     >100 Numbers, Contact Manufacturer
2009/11/23   ########   51438   Type II    N/A       >100 Numbers, Contact Manufacturer
2009/11/23   ########   51370   Type II               48511905D
                                           48511905B,All lots
2009/11/23   ########   51375   Type II    1296-0050 12960024, 12960028
2009/11/23   ########   51391   Type II    MN1610, MN1613, MN1616, MN1620
                                                    >10 Numbers, Contact Manufacturer
2009/11/23   ########   51374   Type II    S18821AM S/N 553918BU4
2009/11/23   ########   51434   Type II    3550-39    >100 Numbers, Contact Manufacturer
2009/11/23   ########   51411   Type III   18700259 61211489
2009/11/23   ########   50937   Type III   KR-41      DK146-01, DK149-01
2009/11/23   ########   51399   Type III   1221       >10 Numbers, Contact Manufacturer
2009/11/23   ########   51502   Type III   N/A        32616
2009/11/23   ########   50981   Type I                 04.808.002, 04.808.003, 04.808.004, 04.808.005, 04.80
                                           04.808.001,All lots
2009/12/07   ########   51507   Type II    D9924      >10 Numbers, Contact Manufacturer
2009/12/07   ########   51588   Type II    AVACT      61233652, 61238956, 61245049, 61252577, 61256798,
2009/12/07   ########   50202   Type II    1049109, 1049110, 1049124, 10499110, 1051157, 1051158, R1049
                                                     >10 Numbers, Contact Manufacturer
2009/12/07   ########   51228   Type II    K2020YS, K2030JN
                                                     >100 Numbers, Contact Manufacturer
2009/12/07   ########   50252   Type II    28000      C202
2009/12/07   ########   44735   Type III   2M9163     >10 Numbers, Contact Manufacturer
2009/12/07   ######## 51522     Type II    1003935, 1003937
                                                     N/A
2009/12/07   ########   51622   Type III              A) >10 Numbers, Contact Manufacturer B) 00-5880-015
                                           A) 00-5880-013-01, 00-5880-014-01, 00-5880-014-02, >10 Numbers
2009/12/07   ########   51623   Type II    RED-700A ZY9021
2009/12/07   ########   51631   Type II              >1000 Numbers, 01.00214.048, 01.00214.050, 01.0021
                                           01.00214.044, 01.00214.046,Contact Manufacturer
2009/12/07   ########   51634   Type II              A) N/AB) N/AC) N/AD) N/AE) N/AF) N/A G) N/AH) N/AI)
                                           A) M6257763B) M8260027C) 227500D) 340013E) 215200F) 21605
2009/12/07   ########   50862   Type II             J577910,
                                           DR0100M, DR0850MJ055610, J539110, J610610
2009/12/07   ########   50935   Type II               A) >10 Numbers, N/AF) N/AG) N/AH) N/AI) N/AJ) N/AK)
                                           A) N/AB) N/AC) N/AD) N/AE) Contact Manufacturer B) >10 Numbers
2009/12/07   ########   51237   Type II    10101      60001-62656 serial number
2009/12/07   ########   51422   Type II               A71461B) A71461C) 4768D) N/AF) N/AG) N/AH) N/A
                                           A) A30260, A) N/AB) N/AC) N/AD) N/AE)973100, A71457E) 973100
2009/12/07   ######## 51464     Type II    94675-5    4408
2009/12/07   ######## 51605     Type III             A) 10024B) 10040
                                           A) 08162807B) 08162815
2009/12/07   ######## 51662     Type II    94260-19 >10 Numbers, Contact Manufacturer
2009/12/07   ########   51664   Type II              All 0788-100-001,
                                           0788-100-000, Lot Numbers 0788-100-0015
2009/12/07   ########   51668   Type II    3010A, 3500-306, 3500-415, 3500-500
                                                     >100 Numbers, Contact Manufacturer
2009/12/07   ########   51677   Type II    6651850     950759, 959261, 961363
2009/12/07   ########   50976   Type II              >10 522HC, 533HC, 633HC, 733HC,
                                           422HC, 433HC, Numbers, Contact Manufacturer 833HC
2009/12/07   ########   51437   Type II    715000      Serial Number 6005
2009/12/07   ########   51583   Type II               A) All Lot Numbers B)
                                           A) 240-050-888 B) 240-050-890 All Lot Numbers
2009/12/07   ########   51650   Type II    CRS126-B T065095, T082003, T119007
2009/12/07   ########   51652   Type II    N/A         N/A
2009/12/07   ########   51665   Type II    90128285 S811270
2009/12/07   ########   51696   Type II               A)
                                           A) N/AB) N/A N/AB) N/A
2009/12/07   ########   51585   Type III              A) 915417B) 915417C)
                                           A) A78803B) A78803C) A78803 915417
2009/12/07   ########   51651   Type III   T1106      S172057
2009/12/07   ########   51706   Type I     87000      N/A
2009/12/07   ########   51708   Type I     87000      N/A
2009/12/07   ########   51737   Type II    BR0064A 702079
2009/12/07   ########   51492   Type III            05072009, 05272009, 06292009, 03102009, 07142008,
                                           KRYP-X-03, KRYP-X-10, KRYP-Z-03, KRYP-Z-10
2009/12/07   ########   50777   Type II               A) M3335JKC) M3335PBD) M7000BFE) 266072MR8, 2
                                           A) M3000LFB) HDMR10368, 7547YR3, 278606MR9, M3000TDF) 229
2009/12/07   ########   51766   Type II    M3335SE HDMR2675, 9948YR1,10833YR2, 11827YR3, 8704YR9, 1
2009/12/07   ########   51421   Type III               K825, K835
                                           K800, K820,>10 Numbers, Contact Manufacturer
2009/12/07   ########   51584   Type III              A) Cup Lot Numbers Starting
                                           A) 4767B) 4768 C) 4771D) 4772E) 4773 With "09" Or LaterB) Cup L
2009/12/07   ########   51663   Type II    2C8864     UR09E21238
2009/12/07   ########   51683   Type II               SP-122, 200.301
                                           500.923 SUB COMPSP-197
2009/12/07   ########   51764   Type II               >
                                           225-414-00010 Numbers, Contact Manufacturer
2009/12/07   ########   51643   Type II    C01A, C01B>10 Numbers, Contact Manufacturer
2009/12/07   ########   51731   Type II    Model 7600 500849356, 500849358, 500849360, 500549361, 5008
2009/12/07   ########   51773   Type II              A) >10 Numbers, Contact H29
                                           A) H18, H27, H29B) H14, H29C) H14,Manufacturer B) >10 Numbers
2009/12/07   ########   51774   Type II                >10 Numbers, Contact Manufacturer
                                           8.0.12, 8.0.23 SP2 , 8.1 SP2, 8.1.1.3, 8.1.1.4,8.1.2, 8.1.3, 8.1.4, 8.3,
2009/12/07   ########   51661   Type I                 A) 8308330B) A1967, A2399C)
                                           A) 385102B) 385150, 385151C) 385164 A1951
2009/12/07   ########   51712   Type II    5.12E+09 155166
2009/12/07   ########   51740   Type II    N/A          All Lot Numbers
2009/12/07   ########   51821   Type II    N/A         Mosaiq 1.40 (All Builds), Mosaiq 1.41 (All Builds), Mosa
2009/12/21   ########   49895   Type II    T1202       S067009
2009/12/21   ########   49896   Type II    T1204       R324001
2009/12/21   ########   51535   Type II               A) >10 31-510, 31-516, 31-520, 31-602B) >10 Numbers
                                           A) 31-400, 31-402, Numbers, Contact Manufacturer B)31-407, 31-40
2009/12/21   ########   51536   Type II    M0064003031
                                                    57271, 57616, 57269, 57613
2009/12/21   ########   51707   Type II                9120, 9125, 9128
                                           9027, 9100,>10 Numbers, Contact Manufacturer
2009/12/21   ########   51819   Type II    N/A         Lot 544202, Exp. 11-2009, Lot 545693, Exp. 05-2010, Lo
2009/12/21   ######## 50747     Type III             >10 Numbers, Contact Manufacturer
                                           05294003, 06239003
2009/12/21   ########   51828   Type II    VT465       >10 Numbers, Contact Manufacturer
2009/12/21   ########   51829   Type II    ZCB00       N/A
2009/12/21   ########   51818   Type II              A) 4230260ppcB) 4226121C) 4237595D) 4183220E) 42
                                           A) 9300A-501PPC B) 9300P-601C) 9390E-501D) 9390A-501E) 930
2009/12/21   ########   51873   Type III              2961
                                           A) 90002B) A) 2012-06 AAB) 2012-10 XT
2009/12/21   ########   51762   Type III             2937776 for
                                           100-467-23, 100-467-50EZManager Max CD, French2936068, 2938
2009/12/21   ########   51926   Type III              2749789
                                           Part # 010-665
2009/12/21   ########   50954   Type III             A) 22086-03EB) 21100-01(2.0), Version 2.1.1 & All Pre
                                           A) 22086-03D,Version 2.1.1 & All PreviousB)21100-01C(2.1)C) 7000
2009/12/21   ########   51373   Type III   KC130      9ED058
2009/12/21   ########   51376   Type III   04 98 717 1987, 3089
2009/12/21   ########   51525   Type II    63747      9H2414, 9H2417, 9H2425, 9J2429, 9J2432, 9J2435, 9J
2009/12/21   ########   51669   Type I     RE83236001096277
2009/12/21   ########   51703   Type I               526337
                                           A06-009, A09-012, A12-016
2009/12/21   ########   51870   Type II    PVT-681MV>10 Numbers, Contact Manufacturer
2009/12/21   ########   51709   Type II              ICU070488, ICU070518, ICU070519
                                           9140-0000-0000
2009/12/21   ########   51857   Type III   01-7141    537407, 536306, 535933
2009/12/21   ########   51915   Type II    FG540000 3257, 2246, 4203, 4166, 4184
2009/12/21   ########   51944   Type II              >10
                                           9140-0000-0000Numbers, Contact Manufacturer
2009/12/21   ########   50030   Type III   94400      >10 Numbers, Contact Manufacturer
2009/12/21   ########   51956   Type II    87000      N/A
2009/12/21   ########   51435   Type II                 Guide, Right Cutting Guide
                                           Left Cutting >10 Numbers, Contact Manufacturer
2009/12/21   ########   51858   Type II    2.08E+10 K13333, K13334, K15491, K15492, 2036
2009/12/21   ########   51921   Type II    309650    9175046
2009/12/21   ########   51937   Type III   9800-3771 Software Version 3.01
2009/12/21   ########   51994   Type III   B4240-10 528752
2009/12/21   ########   51309   Type III             All IW930, IW932, IW934, IW950, IW980, WITH SUFFIX
                                           IW910, IW920,Infant Warmers in Canada.
2009/12/21   ########   50252   Type II    28000     C202
2009/12/21   ########   48857   Type II              A) >10 Numbers, Contact Manufacturer B) 58511631, 58
                                           A) 1350BF85B) I652BF85H, S5507BF85
2009/12/21   ########   52025   Type II               A
                                           A) N/AB) N/A) All Lot Numbers B) All Lot Numbers
2009/07/06   ########   47924   Type III              A) All LotsB) All LotsC) All LotsD) All Lots
                                           A) SYS1000-L3DPHA, SYS1000-L3P, SYS1000-L3PA, SYS1000-L3PHAB
2009/07/06   ########   48344   Type II               A) All LotsB)
                                           A) 4R9734B) 4R9734 All Lots
2009/07/06   ########   48497   Type II               P08321C
                                           06F03-01, 06F03-02
2009/07/06   ########   49192   Type II    N/A        N/A
2009/07/06   ########   49196   Type III              A) > 10, Contact
                                           A) 07566733B) 07566733 ManufacturerB) > 10, Contact Manufac
2009/07/06   ########   47773   Type II    5220493-2 GEHC00070 & GEHC00096
2009/07/06   ######## 48585     Type III   942-061    177
2009/07/06   ######## 48607     Type II    6003-0020 490042, 490656, 503140, 506860, 507311, 516518
2009/07/06   ######## 49030     Type II    5711222    89261CB, 89262CB, 91665DB, 91666DB
2009/07/06   ######## 49105     Type II               A) 60147327, 60230599, 00-5880-015-01, 00-5880-015
                                           A) 00-5880-014-01, 00-5880-014-02,60137094, 60163665, 601732
2009/07/06   ######## 49233     Type III              A) BNMAX, BNMAY, BNMAZB) BNMAX, BNMAY, BNMA
                                           A) 10-9449-01B) 10-9449-01
2009/07/06   ######## 48593     Type II    N/A       All Lots
2009/07/06   ######## 48621     Type II    N/A       687218
2009/07/06   ######## 49146     Type II              N/A
                                           I3000, M4000
2009/07/06   ######## 49223     Type III             A) N/AB) N/A
                                           A) 03H53-01, 03H57-01, 03H57-03B) 07H77-01
2009/07/06   ######## 49279     Type II    1005726-087112051
2009/07/06   ######## 49308     Type III   IM-B02 VX.XX
                                                     N/A
2009/07/06   ######## 49361     Type III   K1021      09061AA
2009/07/06   ######## 47235     Type II    41600-3, 41600-5, 41600-601-044-41600, 41600-052-99, E41600-3
                                                      01-006-41600,
2009/07/20   ######## 49172     Type II              All 0682-001-111
                                           0682-000-449,Lots
2009/07/20   ######## 49202     Type II              N/A
                                           TFD-3000A1/WV
2009/07/20   ######## 49448     Type III             A) VRA124, VRA125, VRA126, VRA127, VRA128B) VRB1
                                           A) 6902317B) 6902318C) 6902319
2009/07/20   ########   49032   Type II    N/A      Serial # 11040079567, 11040079568
2009/07/20   ########   49177   Type II    71034101 > 10 Numbers, Contact Manufacturer
2009/07/20   ########   49199   Type II              A) All lotsB) All lots
                                           A) 302S3-000-000B) 3002-000-000
2009/07/20   ######## 49278     Type II    6704-0-210Serial # 29233201
2009/07/20   ######## 49339     Type III             Serial Numbers Less Than 2810808
                                           MAJ-174, MH-787
2009/07/20   ######## 49446     Type II    BIB2003-01> 10 Numbers, Contact Manufacturer
2009/07/20   ######## 49459     Type III             N/A
                                           643347, 643437, 644459
2009/07/20   ######## 49201     Type II    71420026 08HM17084
2009/07/20   ######## 49362     Type II    32-8105-038-00
                                                     61249897, 61249899
2009/07/20   ######## 49518     Type III   A50001A, A50003A, A50021A, A50023A, WA50003L
                                                     > 10 Numbers, Contact Manufacturer
2009/07/20   ######## 49556     Type III              74908JN00, EXP 17 DEC. 2009, 74908JN01, EXP 17 DEC
                                           7K78-20, 7K78-25
2009/07/20   ######## 49557     Type II    74120152 (L)08CW16248
2009/07/20   ######## 49269     Type II    N/A        N/A
2009/07/20   ######## 49409     Type II               CI-1400-01, CI-1400-02H
                                           CI 1400-01,N/A
2009/07/20   ######## 48878     Type II              A) All LotsB) All LotsC) All LotsD) All CAT# All Lots
                                           A) CAT #04807197001B) CAT #04855094001C) LotsE) 0486239200
2009/08/03   ######## 47838     Type II    K2033LP > 100 Numbers, Contact Manufacturer
2009/08/03   ######## 48476     Type II              A) > 10 Numbers, Contact Manufacturer
                                           A) CS-12123-E, CS-15123-EB) MC-12123, MC-15123 B) > 10 Numbe
2009/08/03   ######## 48484     Type III             > 10 Numbers, Contact Manufacturer
                                           03146693119, 03146707119, 03583031002
2009/08/03   ######## 49293     Type II    K-Junior 8.06E+08
2009/08/03   ######## 49463     Type III   SIM-220A c0910, c9011, c9013, c9014, c9015, c9016, c9017
2009/08/03   ######## 49490     Type II            N/A
                                           NX SOFTWARE 2.0.7000, NX SOFTWARE 2.0.8000, NX SOFTWA
2009/08/03   ######## 49511     Type II    N/A        3508, 3908, 4308, 4808
2009/08/03   ######## 49589     Type III   10041762 10120, 10122
2009/08/03   ######## 49594     Type II    N/A        CO081010
2009/08/03   ######## 49618     Type II              N/A
                                           3007301, 3010432, 3014849
2009/08/03   ######## 49712     Type II               A
                                           A) N/AB) N/A) > 10 Numbers, Contact ManufacturerB) > 10 Number
2009/08/03   ######## 49713     Type II               A) T80998AA, T80998AC, T80550AA, T81105BA, T553
                                           A) N/AB) N/AC) N/AD) N/AE) N/AF) N/A
2009/08/03   ######## 49737     Type I              > 10 Numbers, Contact Manufacturer
                                           MMT-396, MMT-397, MMT-398, MMT-399
2009/08/03   ######## 49796     Type III   N/A        Lot # 6828908, 6829008, 6818808
2009/08/03   ######## 46769     Type II    MCR1511 N/A
2009/08/03   ######## 45337     Type II    APROCH-XX-XXX-XXX-X
                                                     S/N RT908139180GA
2009/08/03   ######## 45604     Type III   B7520AZ, B7530AZ
                                                     > 10 Numbers, Contact Manufacturer
2009/08/03   ######## 46547     Type II    CIC-XXXX-XXXXX-XXXXX* Contact Manufacturer
                                                     > 100 Numbers,
2009/08/03   ######## 46654     Type II               A) N/AB) 4550
                                           A) 4550 110 02031B)N/A 110 09021
2009/08/03   ######## 49529     Type III   62-5442    24180
2009/08/03   ######## 49558     Type III             A) 286801-1, 287425-1B) 286811-1, 287223-1C) 287232
                                           A) 303434B) P2377C) P2600D) P3889
2009/08/03   ######## 49781     Type II              A) BHS 202C) BHS 102D) BHS 130E) BHS 301 SCULP
                                           A) BHS 301B) 131108-0471, 131108-0472, 131108-0474B) 160708-
2009/08/03   ######## 49840     Type II              4411
                                           A) 4125CB)A) N/AB) N/A
2009/08/03   ######## 49912     Type II    475136     M802452, M804502, M807345, M808329
2009/08/03   ######## 48164     Type II    5189396    > 10 Numbers, Contact Manufacturer
2009/08/03   ######## 49726     Type II    7892       17411
2009/08/03   ######## 49853     Type II              A) 245F to 366F inclusive, 001K to 149K inclusiveB) 001
                                           A) 7730ALS, 7730BLU5, 7730GRN5, 7730IALS, 7730MOD, 7730OR
2009/08/03   ######## 49905     Type II    62080822F > 100 Numbers, Contact Manufacturer
2009/08/03   ######## 49956     Type III   227-1043 20994915
2009/08/03   ########   49972   Type II    8637        > 100 Numbers, Contact Manufacturer
2009/08/03   ########   49761   Type III   3.03E+09 All Lot Numbers
2009/08/03   ########   49894   Type II    T5102       R332037, R332037R, S287001
2009/08/03   ########   49895   Type II    T1202       S067009
2009/08/03   ########   49896   Type II    T1204       R324001
2009/08/03   ########   49897   Type III   17696       32
2009/08/03   ########   49952   Type II                A) 870139, 878608,
                                           A) PC30CG'XXX'B) PC30VP'XXX' 866059, 874187, 876386, 882391,
2009/08/03   ########   50003   Type II                > 10 Numbers, Contact Manufacturer
                                           2100C, 21EXS, CLINAC IX H14, CLINAC IX H27, CLINAC IX H29
2009/08/03   ########   50030   Type III   94400       > 10 Numbers, Contact Manufacturer
2009/08/03   ########   49921   Type III               6L45-40B) 6L45-20,
                                           A) 6L45-20, A) All LotsB) All Lots 6L45-40
2009/08/03   ########   49947   Type II    2170-3002A  N/A
2009/08/17   ########   49985   Type II                KNRU, KNTK
                                           514.0300, 514.0400
2009/08/17   ########   48986   Type I     N/A         > 10 Numbers, Contact Manufacturer
2009/08/17   ########   49919   Type II    982A0470 PWH0201
2009/08/17   ########   49926   Type II    1006236-001 S/N'S IT35079, IT35214P, IT35226P
2009/08/17   ########   49950   Type II    8420-107-120, 8420-107-125, 8420-107-130, 8420-107-135
                                                       > 10 Numbers, Contact Manufacturer
2009/08/17   ######## 50114     Type II    27600      C185
2009/08/17   ######## 48114     Type I     4002, 4003 S/N: 3000033364 to 3000038740
2009/08/17   ######## 49872     Type I     5200       > 10 Numbers, Contact Manufacturer
2009/08/17   ######## 49974     Type II    1E+08      All Versions
2009/08/17   ######## 49196     Type III              A) 07566733
                                           A) 07566733B)37820027, 38129027, 38386027, 39195027 B) 37820
2009/08/17   ######## 49994     Type III   3.61E+10 14674120
2009/08/17   ######## 50000     Type III              3272-O10001, 3270-O10002, 3261-O10036
                                           B 810, D 750, D 752, D 850
2009/08/17   ######## 50054     Type II              > 10 Numbers, Contact Manufacturer
                                           970300E, 970302E, 970302F, 970308E, 970311-E
2009/08/17   ######## 49649     Type II              59658ES5, 63221ES6, 69850MA6, 64076ES3
                                           2208203, 2225864, 2225881
2009/08/17   ######## 49712     Type II              A) 2080-0020, 2080-0025, 2080-0030, 2080-0035, 2080
                                           A) 2080-0015, > 10 Numbers, Contact ManufacturerB) > 10 Number
2009/08/17   ######## 49917     Type II              A) All Serial NumbersB) All Serial NumbersC) All 530T0
                                           A) 53000-E1, 53000-F1B) 5300P-E1, 5300P-F1C) 530T0-E1,Serial N
2009/08/17   ######## 49969     Type II    71117083 All Prior To 2009 Excluding 08KM20464 & Excluding 08K
2009/08/17   ######## 49979     Type II               A) > 10 Numbers, Contact ManufacturerB) > 10 Numbe
                                           A) 8600, 8650B) 8015C) 8120D) 8300E) 8000APM, 8100LVPF) 821
2009/08/17   ######## 49983     Type II              A) 417372BU0, 405584BU4, 432687BU2, 406451BU5, 4
                                           A) 2335129B) S1872LC
2009/08/17   ######## 50099     Type II              A) S1872LC
                                           A) 2335129B) 417372BU0, 405584BU4, 406451BU5, 398530BU6B)
2009/08/17   ######## 50100     Type II    18-3200    28635501, 28575801
2009/08/17   ######## 50202     Type II              N/A
                                           1049109, 1049110, 1049124, 1051157, 1051158, R1049109, R1049
2009/08/31   ######## 50075     Type II              >
                                           DSL-10-2000 10 Numbers, Contact Manufacturer
2009/08/31   ######## 48251     Type II    M3335PF WB0029
2009/08/31   ######## 49458     Type II              A) All 0500-110-000, 0500-120-000, 0500-120-025, 050
                                           A) 0500-100-000, LotsB) All LotsC) All LotsD) All LotsE) All LotsF) A
2009/08/31   ######## 50208     Type III             A) N/AB) N/AC) N/A
                                           A) 72200616B) 7205357C) 7205971
2009/08/31   ######## 50252     Type II    28000      C202
2009/08/31   ######## 49787     Type II              RR8, 352166, 352167, 352168, 352169, 352178
                                           352164, 352165, SS8, TT8, UU8, VV8, WW8, XX8, MM9, WW7, XX
2009/08/31   ######## 50175     Type II    425-2020 CL-863
2009/08/31   ######## 50231     Type II               A) All Serial NumbersB) 4767, A10038
                                           A) 4764, A10038B) 4764, A10038C)All Serial NumbersC) All Serial N
2009/08/31   ######## 50277     Type II    8.02E+08 60378581
2009/08/31   ######## 50094     Type II    N/A      J477610, J359510
2009/08/31   ######## 48079     Type II    VG930M     S/NS > QC2082880001
2009/08/31 ########    50093   Type II             J438110, J438910
                                          RE30858301, RE30858302
2009/08/31 ########    50095   Type II    N/A        657819, 660081, 669024, 680190, 682455
2009/08/31 ########    50207   Type III             A) 71358,
                                          A) 1898001B) EC300 71360, 71357, 71361B) 51033, 51356, 51508
2009/08/31 ########    50348   Type III   N/A        N/A
2009/08/31 ########    50203   Type II    TD-WST-01V.11.11.A, V.12.51.A, V.12.61.A
2009/08/31 ########    50168   Type II              B) 04800842190
                                          A) 3666794A) All Serial NumbersB) All Serial Numbers
2009/08/31 ########    50171   Type III   5.03E+09 Lots #153989 And Above
2009/08/312009-07-31
          
            50274   Type I                5-16035, 5-16037, 5-16039, 5-16041, 5-16128, 5-16135
                                          A) 5-16028,A) > 10 Numbers, Contact ManufacturerB) > 10 Number
2009/08/31 ########    50290   Type II    M3536A     > 100 Numbers, Contact Manufacturer
2009/08/31 ########    50376   Type II    IA-2000-S > 10 Numbers, Contact Manufacturer (Numbers With Ex
2009/08/31 ########    50381   Type II              > 70-0071-113, 70-0072-003, 70-0073-003, 70-0074-10
                                          70-0071-103, 10 Numbers, Contact Manufacturer (Lot #'s With Expir
2009/08/31 ########    50342   Type II    TSX-301A/2> 10 Numbers, Contact Manufacturer
2009/08/31 ########    50405   Type II    506788     All Lot Numbers.
2009/09/14 ########    47071   Type III              21005, 21040, 21087,
                                          10093754, 31 11 676, 3111668 21107, 21110, 31036, 34170, 361
2009/09/14 ########    47702   Type II    K-SICO-200 A833541
2009/09/14 ########    47710   Type III              A) > 10 Numbers, Contact ManufacturerB) > 10 Number
                                          A) 20-307, 21-306, 21-307, 27-303, 27-304, 27-315, 27-316B) 27-12
2009/09/14 ########    50228   Type II    7910       1789435
2009/09/14 ########    50356   Type II               A) All Versions And Lot NumbersB) All
                                          A) 250 (Versions 6.1 And Less)B) 250, 250 V7.1.4 Versions And Lot
2009/09/14 ########    50406   Type II               A)
                                          A) N/AB) N/A 5354, 5220, 5418, 99220, 5572, 5465, 5438B) 8985,
2009/09/14 ########    50420   Type II    N/A        042709, 042309, 042209
2009/09/14 ########    50432   Type III   1.15E+08 60471710
2009/09/14 ########    50440   Type II    4027     90402
2009/09/14 ########    50380   Type II               > 10 Numbers, Contact Manufacturer
                                          7021-092, 7021-292, 7021-393
2009/09/14 ########    47422   Type II    M1079844 > 10 Numbers, Contact Manufacturer
2009/09/14 ########    50356   Type II               V7.1.4B) 250 And Lot 6.1 And Less)
                                          A) 250, 250A) All Versions(VersionsNumbersB) All Versions And Lot
2009/09/14 ########    50466   Type II             > M006550161, M006560200, M006560201
                                          M006550160,10 Numbers, Contact Manufacturer
2009/09/14 ########    50472   Type II    101264     10037, 10169, 10014, 10072, 10130, 101212, 110009, 1
2009/09/14 ########    50475   Type III   420104     8192744, 8288054
2009/09/14 ########    50507   Type II              A) S/W 4220B) Model/Catalog #: 7.1C) S/W version 7.1
                                          A) Model/Catalog #:version 7.1B) S/W version 4245C) Model/Catalog
2009/09/14 ########    50527   Type I                > 10 Numbers, Contact Manufacturer
                                          Pedicap, Pedicap 6
2009/09/14 ########    50549   Type I                 200, 2000, 2000/3000, 2200/3200, 300, 3000, 3200, 79
                                          1250, 1500,All Serial Numbers
2009/09/14 ########    50581   Type III   8648375    302351, 303316, 300477
2009/09/14 ########    50595   Type II              A) 915005PK, 915010PKB) 3103PKC) 3104PKD) 2009-
                                          A) 915000PK, All Lots Prior To 2009-08-14B) All Lots Prior To 3105P
2009/09/14 ########    50383   Type II              A) 16391-100C) 16391-11D) 16391-02E) N/AH) N/AI)
                                          A) 08526-01B)N/AB) N/AC) N/AD) N/AE) N/AF) N/AG)16391-201F) N
2009/09/14 ########    50383   Type II              A) N/AB) N/AC) N/AD) N/AE) N/AF) N/AG) N/A
                                          A) 16320-122B) 16320-131C) 16320-293D) 19500-474E) 16320-573
2009/09/14 ########    50401   Type II    MC5057 N/A
2009/09/14 ########    50456   Type II    EPLUS-FP SN C08301701901
2009/09/14 ########    50497   Type I                20630
                                          A) 20630B) A) N/AB) N/A
2009/09/14 ########    50517   Type II               1950C) 2507D) 11555E) 40051F) 11859G) 11846H) 11
                                          A) 50130B) A) N/AB) N/AC) N/AD) N/AE) N/AF) N/AG) N/AH) N/AI) N
2009/09/14 ########    50526   Type II               N/A
                                          64999, 65050 (Syringe)
2009/09/14 ########    50598   Type II               A) > 100 Numbers, Contact ManufacturerB)
                                          A) N/AB) N/AC) N/AD) N/AE) N/AF) N/AG) N/AH) N/A > 10 Numb
2009/09/14 ########    50601   Type II               > M00448110, Contact Manufacturer
                                          M00448100, 10 Numbers, M0048400
2009/09/14 ########    50611   Type I                A) All lots prior to Sept 2009B) All 100-111-020, 100-11
                                          A) 100-105-025, 100-105-030, 100-105-035B)lots prior to Sept 2009
2009/09/14 ########    50618   Type II              K226
                                          0066802, 0066812
2009/09/14   ########   50623   Type II               Serial numbers US00533518 - US00535118
                                           M3535A, M3536A
2009/09/14   ########   50640   Type III   N01IAB     186620, 190582, 190985, 183847
2009/09/14   ########   50625   Type II    Stratus OCTSoftware Version 6.0.0
2009/09/14   ########   50639   Type III              A) >618967B) >618967C) >618967
                                           A) A32898B) A32898C) A32898
2009/09/14   ########   50657   Type II    442840     M901330 And Higher
2009/09/14   ########   50663   Type II               Reagent part # 469785 lots M810083 and earlier, Drug
                                           469600, 469785
2009/06/22   ########   48595   Type II               ALLURA XPER
                                           A) 70834B) A) N/AB) N/A FD10/10
2009/06/22   ########   48605   Type II    7C15-01   > 10 Numbers, Contact Manufactuer
2009/06/22   ########   48608   Type III   L2SUBX    253, 254
2009/06/22   ########   48864   Type II               A) 680 2863
                                           A) 680 2865B)36000116, 36000130B) 56000193, 56000298, 56000
2009/06/22   ########   48882   Type II              N/A
                                           PSS-5F-4-018MT, PSS-5F-4-038MT, PSS-5F-4MT, PSS-6F-4-018M
2009/06/22   ########   48885   Type III   N/A       VSU0802002, VSU0802003, VSU0802001, VSU0711510
2009/06/22   ########   47359   Type III             A) H74916320021, H74919500020, H74919500290, H7
                                           A) 16320-02, 19500-02, 19500-29, 19815-92, H74919815520B) 198
2009/06/22   ########   48935   Type II    960005    2843263, 2869123, 2845534, 2845530, 2844799, 29523
2009/06/22   ######## 48408     Type II              20148707, 20148714, 20153849, 20153865, 20154971
                                           7206010, 7206011, 7210499
2009/06/22   ######## 48912     Type III   N/A       AC001 TO AC0221
2009/06/22   ######## 48937     Type II               A) N/AB) N/AC) N/AD) N/AE) # 4250C) model/catalog #
                                           A) model/catalog # 4235B) model/catalogN/A
2009/06/22   ######## 48997     Type II               N/A
                                           IM-B02V8.06, IM-B02V8.07, IM-B02V8.08, IM-B02V8.09
2009/06/22   ########   47220   Type III   N/A        > 10 Numbers, Contact Manufactuer
2009/06/22   ########   48035   Type II    9027, 9100 > 10 Numbers, Contact Manufactuer
2009/06/22   ########   48613   Type III   MTS11000307160407V3.01, 043600401V200, 043600402V200, 04
2009/06/22   ########   48968   Type II    7211005, 7211006
                                                      > 10 Numbers, Contact Manufactuer
2009/06/22   ########   45258   Type II    N/A        > 10 Numbers, Contact Manufactuer
2009/06/22   ########   48913   Type II              60698102
                                           00-9982-015-18
2009/06/22   ######## 48914     Type II              60886890
                                           00-4827-024-01
2009/06/22   ######## 48988     Type II    00-6428-032-02
                                                     61007046
2009/06/22   ######## 49048     Type II                722042*B) 722017C) N/AE) N/AF) N/AG) 722043*, 722
                                           A) 722041*,A) N/AB) N/AC) N/AD) 722016D) 722021E) N/AH) N/AI)
2009/06/22   ######## 46236     Type II    V100-QBAA-CXAA-XX
                                                    > 10 Numbers, Contact Manufactuer
2009/06/22   ######## 46833     Type II                > 10 Numbers, Contact Manufactuer
                                           MUSESW7-XXXXXXXX
2009/06/22   ######## 46853     Type II                S/N'S SDY09020430GA & SDY09030443GA
                                           CIC-XXXX-XXXXX-XXXXX*
2009/06/22   ######## 48389     Type III   101         8-31313-00003-2, 8-31313-00004-9, 8-31313-00002-5
2009/06/22   ######## 48839     Type II    M8007A N/A
2009/06/22   ######## 47071     Type III               21005, 21040, 21087,
                                           10093754, 31 11 676, 3111668 21107, 21110, 31036, 34170, 361
2009/06/22   ######## 47837     Type II                > 10 Numbers, Contact Manufactuer
                                           2294302, M3000CB
2009/06/22   ######## 48899     Type III   N/A         235018, 235036, S27947, S27957
2009/06/22   ######## 49138     Type III   ######## 7839010, 7910010
2009/06/22   ######## 49074     Type II                > 10 Numbers,
                                           8.1.15, 8.5.11, 8.6.07, HIT Contact Manufactuer
2009/06/22   ######## 49149     Type II                 3.0TB) ACHIEVA
                                           A) ACHIEVAA) N/AB) N/A 1.5T
2009/06/22   ######## 49150     Type II                A) DE53001002 Through DE53107383B) DE53001002 T
                                           A) M2703AB) M2702A
2009/06/22   ######## 49151     Type II    ######## N/A
2009/01/05   ######## 39234     Type II              A) S/N 515959BU5, 518373BU6, 534731BU5, 476532B
                                           A) 2335129-4B) 2335129-3
2009/01/05   ######## 41402     Type II    2M8151K >10 Numbers, Contact Mfr.
2009/01/05   ######## 43632     Type II                INTPKF
                                           3910, 3960,>10 Numbers, Contact Mfr.
2009/01/05   ######## 45100     Type II    505400D 8040201
2009/01/05   ########   45358   Type I     3.01E+09 VERSION 2.00.02a to 2.01.05a/b
2009/01/05   ########   45455   Type II               >10 Numbers, Contact Mfr.
                                           BOS370, COS330, MDK300, MDK305
2009/01/05   ########   45565   Type II               276339, Heparin Lot PH64507
                                           BEQ-VHK 2001
2009/01/05   ########   45612   Type III   8H00-01 Cell-Dyn Sappire Hemoglobin Reagent Syringes (08H49-
2009/01/05   ########   45311   Type II               70834C) N/AC) N/A
                                           A) 70832B) A) N/AB) 708027
2009/01/05   ########   44705   Type II               A)
                                           A) N/AB) N/A >10 Numbers, Contact Mfr.B) >10 Numbers, Contact
2009/01/05   ########   45208   Type II    N/A        >10 Numbers, Contact Mfr.
2009/01/05   ######## 45616     Type II              08 3910-075-501, 3910-075-502, 3910-075-650, 3910-0
                                           3910-075-500, 135 AG2 - 08 294 AG2
2009/01/05   ########   45624   Type III   RXV1A     NC16-182-08, NC16-210-08, NC16-238-08, NC16-189-0
2009/01/05   ########   44891   Type II              0502200 0513069 0507121 0512918
                                           813570, 813572
2009/01/05   ########   45617   Type II               080118-43529
                                           0788-100-001S
2009/01/05   ########   45619   Type II               A) 4034, 4011B) 6037, 6038
                                           A) 1957153B) 5496992
2009/01/05   ########   45626   Type I                A)
                                           A) N/AB) N/A ERLI 0001 To ERLI 1717B) ERLI 0001 To ERLI 1717
2009/01/05   ########   45668   Type II               >10 Numbers, Contact Mfr.
                                           6079300, 6079391, 6079433, 6150614, 6424704, 6424712, 642477
2009/01/05   ########   44645   Type III             A) 697427-01B) 695354-01, 697430-01, 696347-01, 047
                                           A) 04713257190B) 04713109190, 04713184190, 04713214190, 697
2009/01/05   ########   44328   Type III              A) All LotsB) All Lots
                                           A) 360-2D, 480-2D, 720-2DB) RM-9103-S, RM-9103-S0, RM-9103-S
2009/01/05   ########   45563   Type II    69318     All Lots
2009/01/05   ########   45706   Type II    APC-20I APC20i-0006
2009/01/05   ########   44571   Type II    667       100413, 100805, 100974, 101114, 101511, 101677, 10
2009/01/05   ######## 45089     Type III             2732709, 2742732, 2742744, 2714721, 2810259, 2811
                                           04639634001, 235656
2009/01/05   ######## 45736     Type III   0141-0015 HL14301
2009/01/19   ######## 45713     Type II    7167-4092 > 10 Numbers, Contact Mfr.
2009/01/19   ######## 45802     Type II               >100 Numbers, Contact Mfr.
                                           3500-306, 3500-415
2009/01/19   ######## 45786     Type II             N/A
                                           HB43-U010-00/01
2009/01/19   ######## 45340     Type III   221006     80401, 81701, 83306
2009/01/19   ######## 45809     Type II               > 10
                                           084221, 085339 Numbers, Contact Mfr.
2009/01/19   ######## 44611     Type III   N/A        > 50 Numbers, Contact Mfr.
2009/01/19   ######## 45615     Type II               >
                                           M004218400100 Numbers, Contact Mfr.
2009/01/19   ######## 45916     Type II               60969810, 60969811,
                                           00-5971-050-12, 00-5971-050-14 61007188, 60987590, 60969807
2009/01/19   ######## 45864     Type II                6012
                                           6007, 6010,M00560070, M00560071, M00560100, M00560101, M
2009/01/19   ######## 45865     Type II                 50 Numbers, 5662ST, 5663,
                                           5660, 5661,>5661ST, 5662, Contact Mfr. 5663ST, 5665, 5665ST, 5
2009/01/19   ######## 41318     Type I     7.5.51 SP2,H720702
                                                      H72
2009/02/02 ######## 45982       Type II               N/A
                                           9890 010 03631
2009/02/02 ######## 44847       Type II    N/A       53872833
2009/02/02 ######## 45154       Type II    1033869   Manufactured bef.Mar.27/ 08
2009/02/02 ######## 45980       Type III             A) 16384031,
                                           A) 01463908B) 0146390819633033, 28655040, 27767040, 1900403
2009/02/02 ######## 45985       Type II             J311610, J311510
                                           RE30950102, RE30950201
2009/02/02 ######## 45355       Type III   305298    8078251
2009/02/02 ######## 45734       Type III            138702, 122999, 100558, 084225, 098485, 083256, 101
                                           HG1539, RS504, RS505
2009/02/02 ######## 45681       Type II    3121, 5250 >10 numbers, Contact Mfr.
2009/02/02 ######## 45997       Type II    G1-15-1-0 NU010286
2009/02/02 ######## 45862       Type III   36-161070 N/A
2009/02/02 ######## 46050       Type II    801763    0013, 0017, 0020, 0021, 0144, 0193, 0396, 0601
2009/02/02 ######## 45218       Type II    660-0000 950413
2009/02/02 ######## 45219       Type II               A) 23430, 148E) 145X
                                           A) 145B) 146C) 147D)23440B) 23431, 23441C) 23432, 23442D) 234
2009/02/02 ######## 46109       Type II    5703700   Version 1.1-2.4
2009/02/02 ######## 46147       Type II              PSA 6090007, PSA 6090008
                                           PSD-A1, PSS-A1
2009/02/02 ######## 44066       Type II               A) N/AB) N/AC) N/AD) Achieva XRD) Intera 1.5TE) Inte
                                           A) Achieva 3.0TB) Achieva 1.5TC) N/AE) N/A
2009/02/02 ######## 42409       Type III              A
                                           A) N/AB) N/A) >10 numbers, Contact Mfr.B) D03347, D03345, D036
2009/02/02 ######## 43008       Type II    Omnibed   >10 numbers, Contact Mfr.
2009/02/02 ######## 43803       Type II    1M8560R AAS5001530RP, AAS5001531RP
2009/02/02 ######## 45672       Type II              All 61105, 61106, 61107, 61110, 61111, 61113, 61151,
                                           61100, 61103, Lots
2009/02/02 ######## 45821       Type II    N/A       M00265
2009/02/02 ######## 46106       Type II            VERSIONS 3.5.1776, 3.5.1530, 4.0.1.142, 3.5.43, 3.0.48
                                           PROSOLV CARDIOVASCULAR CL , PROSOLV CARDIOVASCULA
2/16/2009   ######## 42702      Type II              A) S18751APB) S18391MD
                                           A) S18751AM,S/N's 1203100025, 452849BU3, 112436VE1, 452927
2/16/2009   ######## 42978      Type II              A) ARXM-0005B) ARYB-0067C) ARYB-0044X
                                           A) 8306611, 8412980B) 8306611, 8411800C) 8306611, 84119600-X
2/16/2009   9/22/2008 44184     Type II              A) 901MME, EN1MME, J41MLE, 4PMMMEB) 6054-101
                                           A) 6051-0830S, 6051-0935S, 6051-1140SB) 6054-0812S,AKKMME
2/16/2009   ######## 44413      Type III   A36097      N/A
2/16/2009   ######## 45109      Type III   S18821AM S/N 554413BU5
2/16/2009   ######## 45192      Type III   N/A         N/A
2/16/2009   ######## 45827      Type II    N/A         N/A
2/16/2009    1/6/2009 45981     Type II                A) 6041-0830, 6041-0935, 6041-1035, 6041-1140B) 60
                                           A) 6041-0730, > 10 Numbers, Contact Mfr. B) > 10 Numbers, Contac
2/16/2009   ######## 46071      Type III               GTI-72L, GTI-72ORB) GTI-B27C) GTI-DR
                                           A) GTI-72C, A) 32.5, 32.6, 32.7, 10.3, 10.7B) 16.2C) 55.0
2/16/2009    8/6/2008 43374     Type II                A) 53069, 53081, 53088, 59 17 53101B) 55127, 55140
                                           A) 7555357B) 7008605C) 7555365D)53097,054E) 10094139F) 1009
2/16/2009   ######## 44190      Type II                A) S/N'S 280105WK8, 311216WK6, 263322WK0, 21925
                                           A) 2115090, 46-270157G-1B) 2275938-7
2/16/2009   9/24/2008 44279     Type II    350805    S/N 568400
2/16/2009   ######## 44332      Type II              A) 813434, 820299, 827471, 829163, 858988B) > 10 Nu
                                           A) SCV30CBXXXB) SLC30LCXXXC) SCV30AAXXXD) SCV30STXXX, SCV
2/16/2009   ######## 44335      Type II             A) S2024EH
                                           A) S2024DTB)S/N E9-0148B) S/N 7019-CMH
2/16/2009   ########    44381   Type II             > 100 Numbers, 00203W, 00204W, 00205W, 00206W
                                           00200W, 00201W, 00202W,Contact Mfr.
2/16/2009   ########    44404   Type III             A) 138B) 138
                                           A) 04385983, 129501B) 04385983, 129501
2/16/2009   ########    44596   Type II    2M86955 SRYB-0074, SRYB-0132
2/16/2009   ########    44731   Type II    81000   S/N'S 20572 & 20693
2/16/2009   ########    45092   Type II              S/N'S J4RR1420F, L4RR1515F
                                           2033579-008
2/16/2009   ########    46137   Type II               A) N/AB) 4535 N/A
                                           A) 4535 673 04201B)N/AC) 673 89331C) 4550 110 09021
2/16/2009    4/4/2008   42738   Type II              A) B77001ST, B78001ME, B79991EP, B79991SSB) 145
                                           A) 2378698-2, > 10 Numbers, Contact Mfr.B) 62426G, 62427G,B799
2/16/2009    8/6/2008   43320   Type II    1500181 07E025, 07F012, 08A027
2/16/2009   ########    43371   Type III             > 10
                                           1011-8302-000 Numbers, Contact Mfr.
2/16/2009   ########    44165   Type II    FND-136102N/A
2/16/2009   ########    44614   Type III             A) 11524979, 11546134, 11516921, 11550539, 115183
                                           A) M001434561, M001434571, M001434581, M001434591, M001
2/16/2009   ########    46154   Type II    03.802.231N/A
2/16/2009   ########    46187   Type II    8139789 S/N 5414
2/16/2009   ########    46242   Type II    4-312B    S07C06
2/16/2009   ########    46281   Type II    9065      Date Codes 2808 And Lower
2/16/2009    4/4/2008   41528   Type II    N/A       N/A
2/16/2009   ########    42263   Type II              HURJ0589, HURJ1533, HURE3333, HURG1431, HURJ056
                                           000630, 000631
2/16/2009   ########    45761   Type III             A) 228083B)
                                           A) 0066238B) 0006428 221299
2/16/2009   ########    46160   Type III   N/A       N/A
2/16/2009   ########    46185   Type II              0205,
                                           A59102, A59126 0206
 2/16/2009   ######## 44523      Type II    SC-5300 7392, 7455, 8015, 8731, 8768, 10686, 10949, 11625, 12
 2/16/2009   ######## 46012      Type II               A) N/AB) N/A
                                            A) N211037, N211039B) N211038, N211040
 2/16/2009   ######## 46194      Type III   MMT-7319 N/A
 2/16/2009   ######## 46273      Type II    CTM/DCTMContact Mfr.
 2/16/2009   ######## 46322      Type III   2028BL     0011043537, 0011049772, 0011059410, 0011069509,
 2/16/2009    4/6/200841821      Type II    N/A        Software Version 4.201 Cat.# 2850101
 2/16/2009   ######## 42811      Type II               A) S/N#S 251168MR1, 7831GQ1, 1078GQ5B) > 10 Num
                                            A) M3335JMB) M3335JB, M3335JG
 2/16/2009   ######## 42976      Type II               A) P6-0404-R, P6-0396-L, P6-0528-R, P6-0390-R, P4-043
                                            A) 00-870638-02B) 00-870637-02C) 2350023D) 00-870632-05, 227
 2/16/2009   ######## 43310      Type II    N/A        97525
 2/16/2009   ######## 43840      Type II               > 100 Numbers, Contact Mfr.
                                            2023617-XXX, K2004W, K2004Z, K2006WB, K2006WC, K2006WD, K
 2/16/2009   ######## 43880      Type II               A) N/AB) N/A
                                            A) SLR8KI-XXX-XXX-XXX-XXXB) PDM-XXX-XXX-XXXX
 2/16/2009   ######## 44822      Type II                M1113715
                                            M1113714,> 10 Numbers, Contact Mfr.
 2/16/2009   ######## 46193      Type II               A) F0813B) F0813C) C0181R
                                            A) 030002-03B) 030002-03C) 030002-03
 2/16/2009   ######## 46344      Type III   AC003      055561, 055562
 2/16/2009   ######## 46352      Type II    10050      > 10 Numbers, Contact Mfr.
 2/16/2009   ######## 46373      Type II    AG55XX All Manufactured Between 2003-2008
 2/16/2009   ######## 44642      Type II    N/A        N/A
 2/16/2009   ######## 45182      Type II    CM0895B 649795, 667911, 649794, 667910, 662546
 2/16/2009    2/2/200946347      Type I                A)
                                            A) N/AB) N/A N/AB) N/A
 2/16/2009   ######## 46393      Type II               NEBATO 124001 TO 124515, CHINA 125001 TO 126001,
                                            MRT 5071, MRT 5111, MRT 5121
 2/16/2009   ######## 45053      Type III   01-1100 040712, 060622, 522267
2009/03/02   ######## 46501      Type III   1957927   25 And Above
2009/03/02   ######## 44729      Type II    N/A       N/A
2009/03/02   ######## 40775      Type II              A) > 10 Numbers, Contact
                                            A) 1505-9000-000B) 1505-8538-000 Mfr.B) > 10 Numbers, Contac
2009/03/02   ######## 45544      Type II    GEF09700 > 10 Numbers, Contact Mfr.
2009/03/02   ######## 46270      Type II               > 10 00-7806-035-02
                                            00-7806-035-01,Numbers, Contact Mfr.
2009/03/02   ######## 46271      Type III   14.32.07-202405362
2009/03/02   ######## 46272      Type II    TSX-301A/2N/A
2009/03/02   ######## 46533      Type II               A) N/AB) N/A
                                            A) 32-8105-027-04, 32-8105-027-06B) 32-8105-043-01, 32-8105-04
2009/03/02   ######## 46534      Type III   3A47-48 68761HN00
2009/03/02   ######## 44280      Type II    904781     164080
2009/03/02   ######## 46208      Type II    5520-B-400J5119SH8NT
2009/03/02   ######## 46302      Type II    5520-B-200SJE3F
2009/03/02   ########    46543   Type III   AC-57F1   62729
2009/03/02   ########    46544   Type II    VH-2000   8090272, 8090571, 8110571, 8100771, 8070771
2009/03/02   ########    46546   Type I               8120271,
                                            HSK-2038, HSK-2043 8101072
2009/03/02   ########    45860   Type II    5729      > 10 Numbers, Contact Mfr.
2009/03/02   ########    46521   Type II    N/A       Release 4.1.1 & Higher
2009/03/02   ########    46568   Type III   626553    N/A
2009/03/02   ########    46636   Type II             A) 872728, 875378B) 872013
                                            A) SAN30PAXXXB) SOP30ASXXX
2009/03/02   ########    46641   Type II    N/A       31895, 32120, 32689, 32565, 32383
2009/03/02   ########    46652   Type II    N/A      08090F12
2009/03/02   ########    45627   Type II             8102
                                            A230TR/V810TR
2009/03/02   ########    46404   Type II               A) APM797, APM298, APM980B) APM272, APZ116, AP
                                            A) Z117H, Z320H, Z969HB) DC512, J286G, J544G, J546G, J547G,
2009/03/02   ########   46654   Type II               A) N/AB) 4550
                                           A) 4535 670 88051B)N/A 110 02031
2009/03/02   ########   45519   Type II    03-2794-0 > 10 Numbers, Contact Mfr.
2009/03/02   ########   46554   Type III   7142-4053 06DM08612
2009/03/02   ########   46556   Type II    126646     08LM02210
2009/03/02   ########   45280   Type II                2M8161, DNM 8151 B) 2M8153, 2M8163, DNM 8153C
                                           A) 2M8151,A) All Serial NumbersB) All Serial NumbersC) All Serial N
2009/03/02   ########   46558   Type II    101638     07DM13310, 08FM16961
2008/10/13   ########   40888   Type II    N/A        S/N 212910
2008/10/13   ########   43453   Type II               700.11505, 700.11550, 700.11560
                                           700.11500, GA-1304-0001 to GA-2608-1371
2008/10/13   ########   43709   Type II    TD-SYN-01 N/A
2008/10/13   ########   43711   Type II               69734801, 60189501, 60117701, 60451501, 60117601
                                           11556495216, 11556509216
2008/10/13   ########   43751   Type II               A) >100 Numbers, Contact Mfr.B) >1000 Numbers, Con
                                           A) 80403-000017, 80403-000077, 80403-000178B) 80403-000XXX
2008/10/13   ########   43769   Type III              N/A
                                           03051315600, 28183112001
2008/10/13   ########   43935   Type III   QST        SN's 1851059 & 1851060
2008/10/13   ########   44000   Type II               1130.67FO
                                           1130.67BO,N/A
2008/10/13   ########   44063   Type II    N/A       N/A
2008/10/13   ########   44065   Type II              0
                                           60-6085-100710121 through 0804111
2008/10/13   ########   44075   Type III   205-1902 08F277F
2008/10/13   ########   44076   Type II              All
                                           0682-000-415 Sold From Aug./06 to Jan./07
2008/10/13   ########   44080   Type III   A16953    889708, 889709
2008/10/13   ########   44081   Type II              >10 Lot Numbers, Contact Mfr.
                                           32612, 32650, 32651, 32652, 32653, 32654, 32655, 32656, 32657,
2008/10/13   ########   44083   Type II              >10 Serial Numbers, Contact Mfr.
                                           KMBB4MLU2FUS, KMBB4MSU2FUS, KMBB4NSX2FUS, KMBB4OLU2
2008/10/13   ########   44109   Type III   640-4026 07L41
2008/10/13   ########   44114   Type II               A) 82-65569-10, 75-65474-10, 200-262-51, 76-65468-1
                                           A) 100-200-51, 100-201-51, 100-202-51B) 84-65680-10,200-264-51,
2008/10/13   ########   42408   Type II    K2033JS S/N 0000000FYZ1P21
2008/10/13   ########   43872   Type II               3387-40B) All Lots
                                           A) 3387-28,A) All LotsB)3389-28, 3389-40
2008/10/13   ########   44147   Type III              A) 92241, 645N4Z8, 95243, 93477, 95071, 95248, 9390
                                           A) 100 90 679B) 100 90 258
2008/10/13   ########   44179   Type II             All Lots Distributed Between
                                           0682000850, 0682000851, 0682000852 Dec.23, 2003 And Sept.30
2008/10/13   ########   43369   Type II    915-2418 899320
2008/10/13   ########   43384   Type II    07-300     040109, SP040109
2008/10/13   ########   44005   Type II               A) >100 Numbers, Contact Mfr.B) >100 Numbers, Conta
                                           A) 8626, 8627B) 8637
2008/10/13   ########   44245   Type II    10 014 063 1094, 1200, 1262, 1281, 1313
2008/10/13   ########   44260   Type II               N/A
                                           20300, 20301
2008/10/13   ########   43456   Type III   N/A        SXXXX05/08, SXXXX06/08, SXXXX07/08, SXXXX08/08, S
2008/10/13   ########   44077   Type III   1E66-04 61388M100, 57919M100, 54754M100, 52632M100
2008/10/13   ########   44161   Type III   8H00-01 N/A
2008/10/13   ########   44163   Type I     925B       M335870
2008/10/27 ######## 44128       Type III   07RD-7072RD8082701, 8071814, 8071013, RD8082502
2008/10/27 ######## 44258       Type III   8547171    12502E
2008/10/27 ######## 44262       Type III   9K14-01    S/N 4145 And Greater
2008/10/27 ######## 43854       Type II            All
                                           MASTER VII Lots
2008/10/27 ######## 44234       Type II    BPX 30     79783, 81119, 82259, BPX30004583 thru BPX30005642
2008/10/27 ######## 44265       Type II    101264     N/A
2008/10/27 ######## 44289       Type III            P8082908, RD8080602
                                           MD 40325-XO
2008/10/27 ######## 44298       Type II    8377520    54058, 54091, 54101, 54118, 54121, 54152, 54200, 842
2008/10/27 ######## 44104   Type III   2320, 2330 N/A
2008/10/27 ######## 44172   Type III            >100,
                                       ILAB120CART Contact Mfr.
2008/10/27 ######## 44291   Type II             >10, Contact Mfr.
                                       05CR000021, 799-13000-00, 799-14000-00
2008/10/27 ######## 41751   Type II    5147845-2 >10, Contact Mfr.
2008/10/27 ######## 42752   Type II    801763      396
2008/10/27 ######## 43401   Type II              313366, 322198, 341686, 2037X, 2502X
                                       195215, 195274
2008/10/27 ######## 43616   Type III              A) >10, Contact Mfr.B) >10, Contact Mfr.
                                       A) 221238, 299896B) 221961, 222207, 222208, 222247, 292271, 29
2008/10/27 ######## 43841   Type III   256050      8108342, 8128099
2008/10/27 ######## 44082   Type II              >100, Contact Mfr.
                                       0015690, 0015691, 0015693, 0015694, 0015698
2008/10/27 ######## 44345   Type I     1315        less than 3000, VAD-1401, VAD-0693, VAD-4113, VAD-
2008/10/27 ######## 44382   Type II    DF270       DB9093, GA9043, GD9069, GD9087
2008/10/27 ######## 44393   Type II              All Lot Numbers
                                       291.910.01S, 291.911.01S, 291.911.03S, 291.915.01S, 291.916.01S
2008/10/27 ######## 44394   Type III   K800        01080100263RO, 01080300290RO, 01080300294RO, 0
2008/10/27 ######## 44259   Type II               A54378, A54379B) 722630, 823675B) 714944, 717432
                                       A) A25656, A) 722631, 823677,81600, A19889, A45144C) 81600N,
2008/10/27 ######## 44403   Type II              All Lot Numbers
                                       107493 6023014700
2008/10/27 ######## 44389   Type III   71420166 08FT20704
2008/10/27 ######## 44412   Type III   10140720 8733, 8870, 9604, 9656, 9666
2008/11/10 ######## 44299   Type III   N/A         >10 Numbers, Contact Mfr.
2008/11/10 ######## 44408   Type II              A) >100 Numbers, Contact Mfr.B) >100 Numbers, Conta
                                       A) 6203-000-000, 6205-000-000B) 6206-000-000, 6207-000-000, 6
2008/11/10 ######## 44428   Type III   N56AB       170113
2008/11/10 ######## 42906   Type II    6.02E+09 All Lots / Tous les lots
2008/11/10 ######## 44324   Type II              KM560104, - KM56-11074
                                       KM560101, KM56-10015KM560108, KM560181, KM560184, KM560
2008/11/10 ######## 44433   Type III             A) 130738006, 130738009, 130742003, 130742006, 13
                                       A) 130738003,All Lots / Tous les lotsB) All Lots / Tous les lotsC) All
2008/11/10 ######## 44440   Type II              1310743
                                       100/812/070
2008/11/10 ######## 44415   Type III            A) 13435353B) 13465853
                                       A) NR7TCS8YB) NR7TCSIY
2008/11/10 ######## 44438   Type III             A) T707069, T711053, T804050, T807146, T612017B) M
                                       A) 443797B) 657365
2008/11/10 ######## 44256   Type III              32041-22, 32041-28, 32041-31, 32041-34
                                       A) 3441BB) A) F1012719, F1012712B) F1012714, F1012723, F1012
2008/11/10 ######## 44442   Type II    10252047 10020, 10022, 10036, 10050, 10051, 10052, 10064
2008/11/10 ######## 44520   Type III   2490C       >100 Numbers, Contact Mfr.
2008/11/10 ######## 44521   Type III   6800189     1098
2008/11/10 ######## 44522   Type I     270-2600 All Lots / Tous les lots
2008/11/10 ######## 44527   Type II             RT240 Lot# 050329 to 080429RT340 Lot# 041018 to 07
                                       RT240, RT340
2008/11/10 ######## 44535   Type II              KM560104, - KM56-11074
                                       KM560101, KM56-10015KM560108, KM560181, KM560184, KM560
2008/11/10 ######## 44383   Type II    17096       0010, 0011
2008/11/10 ######## 44551   Type II    10275009 68504, 68506
2008/11/10 ######## 42727   Type III             NGSA2620, NGSA3178, NGSA2400, NGRL2194, NGRL
                                       000716, 000720, 000722
2008/11/10 ######## 44444   Type II              A) All LotsB) All LotsC) All Lots
                                       A) 6007-003-000B) 6007-003-100, 6007-003-150, 6007-004-100, 60
2008/11/10 ######## 44537   Type II              A) 601534,
                                       A) 973100B) 973100 601081, 601086, 601506, 601316, 601318, P
2008/11/10 ######## 44548   Type II             A) 1281281, 1288451, 1242634 B) 1240049, 1284910
                                       A) ONS1733, ONS1733-500B) ON1733
2008/11/10 ######## 41088   Type II               A) > 100,
                                       A) N/AB) N/AC) N/A Contact Mfr.B) > 40, Contact Mfr.C) 05080866
2008/11/10 ######## 44159   Type III             A) 1548J, 1548H, 1718U, 1758F,
                                       A) 7211004B) 7211005, 7211006C) 7211008 1848U, 1928FB) 1548
2008/11/24 ######## 44345   Type I     1355      VAD-1401, VAD-0693, VAD-4113, VAD-4087
2008/11/24 ######## 44505   Type II              >10 Lot Numbers, Contact Mfr.
                                       61452, 61454, 61456
2008/11/24 ######## 44510   Type II    101264    10037, 10169, 10014, 10009, 10129, 10072, 10130
2008/11/24   ######## 44636     Type II    C/IS-10    UNIU3476, UNIU3477
2008/11/24   ########   42942   Type III   A) N/AB) N/A JUSAF268 & JURFF131B) JURLF113
                                                      A)
2008/11/24   ########   43124   Type II    N/A        U1541632, U1354142, U1423782, U1530194, U153264
2008/11/24   ########   44323   Type III   2400       32892
2008/11/24   ########   41529   Type II    1002375 613969DSTXL, 418649DSTXL, 418549DSTXL2, 418549D
2008/11/24   ########   43649   Type II    F003      13611-12419/1, 13611-12419/2, 13611-12419/3, 1361
2008/11/24   ########   44317   Type II    87000     N/A
2008/11/24   ########   44418   Type II              >10
                                           801040, 801041Lot Numbers, Contact Mfr.
2008/11/24   ########   44419   Type II              >10 Lot Numbers, Contact Mfr.
                                           801040, 801041, 816571
2008/11/24   ########   44420   Type II    801763    0013-0610, 1001-1026
2008/11/24   ########   44638   Type III   66090     236036
2008/11/24   ######## 44646     Type II                A) V3-X-XB) Inteleviewer V3-X-X
                                           A) InteleviewerVersions 3.5.2.P1 to 3.5.2.P56B) Versions 3.6.1.P1 t
2008/11/24   ########   41339   Type I     360-1300-E1L3 Lot Numbers, Contact Mfr.
                                                     >10
2008/11/24   ########   44525   Type II              A) N/AB) N/AC) N/AD) N/AE) M8004AD)
                                           A) G1 M1013A, G5 M1019AB) M8002AC)N/AF) N/A M8007A E) M
2008/11/24   ########   44648   Type II    E700       >60 Lot Numbers, Contact Mfr.
2008/11/24   ########   44675   Type III     8208431 All Lots / Tous les lots
2008/11/24   ########   44701   Type II               EE, UNO 100 EMB) UNO 102, UNO 102 EE, UNO 102 1
                                           A) UNO 100A) 7090001-7096200B) 20001-21300, 30001-48100C)EM
2008/11/24   ########   44719   Type III   07L01-01 N/A
2008/11/24   ########   44722   Type III   33349      827697, 825067, 823506, 722872, 720546
2008/11/24   ########   44723   Type III   33710       827162, 824408, 821289
2008/11/24   ########   44724   Type II                A) N13673,
                                           A) 702746B) 702749 N27214, N27215, N27250, N29051, P01762
2008/11/24   ########   44735   Type II    2M9163 >10 Lot Numbers, Contact Mfr.
2008/11/24   ########   44744   Type II    TD-SYN-01 TD-Synergy V03.12.B all UNIX, TD-Synergy V03.13.1 all
2008/11/24   ########   44791   Type III   03L77-01 N/A
2008/11/24   ########   44617   Type I                 >
                                           102139, 135540 Lot Numbers, Contact Mfr.
2008/11/24   ########   44867   Type II                A) 071108997, 091608036, 091608035B) 091608034
                                           A) 400-40-EP-9F, 800-80-EP-8FB) 500-50-EP-9F
2008/11/24   ########   37014   Type II                A) 206057B) > 10, Contact Mfr.C) 972214EF) 972215E
                                           A) 970200B) 972211EC) 972212ED) 972213EE)206179, 206605, 206
2008/12/08   ########   44644   Type III   ######## All Lots / Tous les lots
2008/12/08   ########   44912   Type II    0575-100-0008235012
2008/12/08   ########   44651   Type II    E-WNV02M7262
2008/12/08   ########   44870   Type II    DI-100, DI-50
                                                       1057962, 1086185
2008/12/08   ########   44449   Type II    SR0035C 7.9E+08
2008/12/08   ########   44679   Type III   10094833 > 10, Contact Mfr.
2008/12/08   ########   44693   Type III             A) 2224B) 2589, 2459, 2616, 2667C) 2473, 2559, 2618,
                                           A) 9822685B) 1940753C) 1940035, 4504200D) 9401506E) 9822693
2008/12/08   ########   44750   Type II              MOSAIQ
                                           40003-001000-RO 1.30 & 1.40
2008/12/08   ########   44850   Type III   32-231032 All Lots / Tous les lots
2008/12/08   ########   44852   Type III   30-144101 All Serial Numbers / Tous les numéros de série
2008/12/08   ########   44968   Type III   CT0223B 610298
2008/12/08   ########   44980   Type III   DR0680M J053110, J219010, J275210, J293610
2008/12/08   ########   44984   Type II              A) HDJL50287, HDJL50330, HDJL50329B) > 10, Contact
                                           A) M1118179B) M1110875
2008/12/08   ######## 44985     Type III   DR0620M J178510
2008/12/08   ######## 44726     Type III   10348531 313171
2008/12/08   ######## 44694     Type III   8139789 5414
2008/12/08   ######## 44814     Type III   N/A        100207, 072506, 102307, 511053
2008/12/08   ########   45060   Type II    N/A         070826D
2008/12/08   ########   45077   Type II    10101       All Lots / Tous les lots
2008/12/22   ########   44645   Type III               A) 697427-01B) 695354-01, 697430-01, 696347-01, 04
                                           A) 04713257190B) 04713109190, 04713184190, 04713214190,697
2008/12/22   ########   44524   Type II    S1720       N/A
2008/12/22   ########   44896   Type III   29499       3073259, 3093659
2008/12/22   ########   44983   Type II                 1009.81B1, 1009.81D1, 1009.81E0, 1009.81E1
                                           1009.81B0, N/A
2008/12/22   ########   44999   Type II    N/A         Serial#s TPNK00001-TPNK00146, Serial#s TPOK00001-T
2008/12/22   ########   45105   Type II                A) All Serial NumbersB) All Serial NumbersC) All Serial N
                                           A) 21-1805-51, 21-1806-51, 21-1807-51, 21-1815-50, 21-1816-50,
2008/12/22   ########   45115   Type II    6001-386-000JA201F85AS
2008/12/22   ########   45117   Type III               A) 252153379,
                                           A) 02817045B) 02817045 259603379, 266483379, 272823379B) 1
2008/12/22   ########   45120   Type II    03.802.231N/A
2008/12/22   ########   45139   Type III   RKSH1       72
2008/12/22   ########   45189   Type III   N/A         80661-23
2008/12/22   ########   44333   Type III               PFFA2111107
                                           PMF20-100-10CS
2008/12/22   ########   44817   Type II                A) FD10/10B) Allura XPER FD20/10C) 722016D) 722043
                                           A) Allura XPERN/AB) N/AC) N/AD) N/AE) N/AF) N/A
2008/12/22   ######## 44820     Type II    3.01E+09 N/A
2008/12/22   ########   44878   Type II              A) N/AB) N/A
                                           A) TSX-101A/DX, TSX-101A/IXB) TSX-101A/EX, TSX-101A/HX
2008/12/22   ########   44879   Type II    TSX-301A/2N/A
2008/12/22   ########   44908   Type II    70834     N/A
2008/12/22   ########   45051   Type II    411104    08-TM-51
2008/12/22   ########   45102   Type III   08H67-01 N/A
2008/12/22   ########   45263   Type II    7174-0250 08FM05400
2008/12/22   ########   45281   Type III   K6440      08198AD
2008/12/22   ########   45139   Type III   RKSH1       72
2008/12/22   ########   45314   Type II    N/A         6120480
2008/12/22   ########   44650   Type II    N/A         All Lots
2008/12/22   ########   44673   Type II                 FD10
                                           Allura XPERN/A
2008/12/22   ########   45310   Type II                A) FD20/10B) 722016C) 722043*D)
                                           A) Allura XPERN/AB) N/AC) N/AD) N/AE) N/A Allura XPER FD10E)
2008/12/22   ########   45379   Type II                A) All Serial NumbersB)
                                           A) 804507-XXB) 3009166, 800418 All Serial Numbers
2008/12/22   ########   45255   Type III   7L02-01 N/A
2008/12/22   ########   45433   Type II                N/A
                                           9890 010 03631
2008/12/22   ########   43740   Type II                A) 044900B) 060930, 071130, 181390, 584110, 851620
                                           A) N/AB) N/AC) N/A
2008/12/22   ########   44757   Type II                8050961, 8062361, 8041051, 8050561
                                           1011759-08, 1011759-12
2008/12/22   ########   45093   Type II                N/A
                                           CG10180, CG10180CA
2008/12/22   ########   45313   Type II                N/A
                                           4535 670 88051
2008/12/22   ########   45457   Type II    N/A         release 4.3.1 to 4.40.00
2008/12/22   ########   45466   Type II                A) 113634, 113637B) 197279, 113634, 197289, 113637
                                           A) 00944686, 05788372, T03-1220-62, T03-1221-62B) 00944686, 0
2008/12/22   ########   45468   Type II    12112       2.01E+09
2008/12/22   ########   45470   Type III   N/A         2.23E+09
2008/12/22   ########   45472   Type III               A) EXP EPS07C) - 2013/09B) EXP 2012/09 - 2013/09C) E
                                           A) EPS01B) EPS03, 2012/09 EPS09
2008/12/22   ########   45495   Type III               N/A
                                           100-443-23, 410-108-23
2008/12/22   ########   45500   Type II    N/A         KAUK00115 TO KAUK00130
2008/12/22   ########   45351   Type II                A) > 10 2140-000-000
                                           A) 2130-000-000B) Numbers, Contact Mfr.B) > 10 Numbers, Contac
2008/12/22   ########   45354   Type II                A) > 10 2140-000-000
                                           A) 2130-000-000B) Numbers, Contact Mfr.B) > 10 Numbers, Contac
2008/12/22   ########    45529   Type III   OQOA11 37243, 37385, 37434, 37653
2008/12/22   ########    45540   Type II                > 10 Numbers,
                                            Eclipse Version 6.8 & 8.0 Contact Mfr.
2008/12/22   ########    45547   Type II                > 10 Numbers, Contact Mfr.
                                            H08, OBI 1.2.05 (Versions Prior V1.3), Version 1.0.15
 9/29/2008    7/2/2008   42986   Type II                N/A
                                            COBSW1-0001, COBSW1-0002, COBSW1-0004
 9/29/2008   ########    41671   Type II                >1000 Numbers, Contact Mfr.
                                            VMP306, VMP306PX, VMP426PX, VMP448PX
 9/29/2008    5/1/2008   42405   Type III               7344768, 7344840, 7344841, 7344842,
                                            366664, 367880, 367884, 367886, 367960, 3679627344844, 73099
 9/29/2008    8/4/2008   43317   Type III               All
                                            2217B, 2217SLLots
 9/29/2008    8/7/2008   43337   Type II    N/A        08E182E
 9/29/2008   ########    43343   Type II              HIT0437, HIT1016, Build 8.1.18, SP1 & SP2
                                            Product Code: Hit Release 8.1, HIT1432, HIT1433, HIT1481, HIT153
 9/29/2008    6/2/2008   43346   Type II              H462016, H462017, H462021, H462022, H462023, H46
                                            Product Code: H46 Version 6.6.5042, 6.6.504
 9/29/2008    8/7/2008   43380   Type II                 X-Ray
                                            Gallileos 3DAll Lots
 9/29/2008    8/8/2008   43455   Type III               Contact Mfr.
                                            D 3344, D 3446
 9/29/2008   ########    43457   Type III   ######## All Lots
 9/29/2008   ########    43583   Type II    454237      B120703
 9/29/2008   ########    43591   Type II                842389, 845216, 848119, 851494
                                            SAN30CL 'XXX'
 9/29/2008   ########    43605   Type II                91496
                                            A) 90496B) A) All LotsB) All Lots
 9/29/2008   ########    43629   Type II                A) All 32410, 32420, 32810, 32820, 32830,
                                            A) 32010, 32020, Serial NumbersB) All Serial Numbers 33220, 3383
 9/29/2008   ########    43632   Type II                 INTPKF
                                            3910, 3960,>10 Numbers, Contact Mfr.
 9/29/2008   ########    43657   Type III   A10826     722151, 722850, 822409, 824553
 9/29/2008   ########    42391   Type III                Low Loss ReservoirB) CBB300738XXXXB) XXX0634XXX
                                            A) LiberatorA) CBB300634XXXX TOHi-Flow Sprint Stroller
 9/29/2008   ########    43677   Type I     64999       N/A
 9/29/2008   ########    43678   Type I     87000       N/A
 9/29/2008   ########    43696   Type II              A) N/AB) N/AC) N/A
                                            A) TSX-101A/IXB) TSX-101A/HXC) TSX-301A/2
 9/29/2008   ########    43707   Type II    OTB42120 >10 Numbers, Contact Mfr.
 9/29/2008    9/5/2008   43716   Type II                A) 15606300B) 15606300
                                            A) 04490738190B) 11985965216, 11986562122
 9/29/2008   ########    43722   Type II    E-WNV01G 8106
 9/29/2008   ########    43736   Type II    N/A         N/A
 9/29/2008   ########    43745   Type II                A) 55433, 55437B) 57119, 57160C) 44274
                                            A) 7008605B) 7555365C) 7728392
 9/29/2008   ########    43747   Type I                 A) >10 Serial Numbers, Contact ManufacturerB) H77016
                                            A) H14 - CLINAC, CL-21EXS, H18 - CLINAC, CL-600C, H27 - CLINAC, C
 9/29/2008   ########    43748   Type III   34205       894069, 794068, 794067, 794066, 794065, 794064
 9/29/2008   ########    43750   Type III   33885       821598
 9/29/2008    9/3/2008   43832   Type III   74 14 803 1072
 9/29/2008   ########    43843   Type II                6218AC) 6248VAL
                                            A) 6216AB) A) 0000699022, 0000648673, 0000700650, 000062657
 9/29/2008    9/5/2008   43834   Type III               A) 74 83 113
                                            A) 74 72 884B)GAA0323B) GEA0491, GEA0509, GEA0570, GEA0599
 9/29/2008    9/5/2008   43838   Type III               A) 74 83 113
                                            A) 74 72 884B)GAA0119, GAA0140, GAA0168, GAA0266, GAA0267,
 9/29/2008   ########    43875   Type II                >100
                                            80403-XXXXXX Numbers, Contact Mfr.
 9/29/2008    9/5/2008   43879   Type II                All
                                            0678-000-537 Lots
 9/29/2008   ########    43920   Type II                >100 0015603, Contact
                                            12079, 0015602, Numbers, 0015610Mfr.
 9/29/2008   ########    41511   Type II                7156175, 7212948, 7123225, 7150947, 7184442, 7184
                                            309605, 309703
 9/29/2008   ########    43458   Type II                A) MHD-98B
                                            A) MHD-97BB)B163006631B) B093004858, B093004926
 9/29/2008    7/2/2008   43488   Type II    2450520 615971, 624618, 635553
 9/29/2008    9/4/2008   43587   Type III               GL11, GL12 (OPENSTEP), GL12 (OSX), GL13
                                            06246360, 06548414, 06550397, 06706079, VG 20030-007, VG 20
 9/29/2008   ########    43799   Type II                LKPG5
                                            A) LKPG1B) A) All Lot NumbersB) All Lot Numbers
 9/29/2008   ########    43918   Type II                A) >10 Lot Numbers, Contact Mfr.B) >10 Lot 523800,
                                            A) 544230, 544240B) 523700, 523735, 523760, 523770,Numbers,5C
 9/29/2008   ########    44004   Type III   7L02-01 All Serial Numbers
 9/29/2008   ########    44013   Type III   2Z2831G 8041819
 9/29/2008   ########   44028   Type I                >10 Numbers, Contact Mfr.
                                           H14 - CLINAC, CL-21EXS, H18 - CLINAC, CL-600C, H27 - CLINAC, CL-2
2008/04/14   ########   39784   Type III               L2KPEP6B) L5KPEP2,
                                           A) L2KPEP2,A) Lot 105LB) Lot 105LL5KPEP6
2008/04/14   ########   41501   Type III   L2KCE6     Lot 232
2008/04/14   ########   41536   Type II    99425     >100 Numbers - Contact Manufacturer
2008/04/14   ########   41543   Type II              >10, Contact Manufacturer
                                           SOP30TJXXX, SOP40TJXXX
2008/04/14   ########   34725   Type II              A) 2224, 2133, 2319B) 2616, 2667, 9401654E) 9401506
                                           A) 8515520, 9822685B) 1940753C) 9822693D)2589C) 2264D) 2427
2008/04/14   ######## 41407     Type II              10104, 10107, 10111, 10117, 10120, 10121, 10127, 101
                                           HUH-312, UHU-318
2008/04/14   ######## 41524     Type II    20938      7J30626
2008/04/14   ######## 41609     Type III   102-25     33361
2008/04/14   ######## 41618     Type III   N/A        1940667, 1940695, 2681547
2008/04/14   ######## 41634     Type III              TDA 10061, TDA 10062,
                                           PTD11001, PTD22002, PTD33003 TDA 10063
2008/04/14   ######## 41639     Type I     FJ.120096 0207A, 0107A, 0207B, 0307A, 0407A
2008/04/14   ######## 41659     Type II    6801375 S/N Less Than 34001351
2008/04/14   ######## 41706     Type III   2714A1-S 20071107
2008/04/14   ######## 41709     Type II    SEL-00001 2.84E+10
2008/04/14   ######## 39316     Type II                9012B1011
                                           9012B1001,N/A
2008/04/14   ######## 41293     Type II               13821, 13820, 13822
                                           514, 514X, 515
2008/04/14   ######## 41294     Type III              A) 14424300 B) 15812800
                                           A) 03800130190B) 04490843190
2008/04/14   ######## 41513     Type II               A) N/AB) N/AC) N/AD) N/AE) N/AF) N/AG) N/AH) N/AI)
                                           A) U773B) 5071-175C) C8804D) 5071-228E) L124F) 5044-145, 5053
2008/04/14   ######## 41552     Type II    ISMHA32 593025-5
2008/04/14   ######## 41305     Type II    N/A        H291166, H140728, H180311, H290107, H272380, H29
2008/04/14   ######## 41319     Type II    N/A        H881466, H882825, H882826, H883012, H883504, H88
2008/04/14   ######## 41522     Type II    N/A        >10, Contact Manufacturer
2008/04/14   ######## 41571     Type III              765291,
                                           LOA002, LOA003 765295
2008/04/14   ######## 41574     Type II               All V4648, V4664, V4666
                                           V4479, V4483,lot numbers
2008/04/14   ######## 41615     Type II    N/A        H487009, H486914
2008/04/14   ######## 41705     Type I                A) All LotsB) All LotsC) All LotsD) All Lots
                                           A) 7000-2000B) 4850-2000C) 4800-2000D) 84811201
2008/04/14   ######## 41721     Type II    RF451      GB9021, GB9029
2008/04/14   ######## 41727     Type II               N/A
                                           XRT 0401, XRT 0411
2008/04/14   ######## 41756     Type II               A) 49050510, 2160,
                                           A) 078-A001-14 B) 078-A010-072161, 4560431, 30760141,IRL5258
2008/04/14   ######## 41762     Type III              >10, Contact Manufacturer
                                           DP8130, DP8430, DP8430A
2008/04/14   ######## 41636     Type II               A) >10, Contact ManufacturerB) >100,Contact Manufac
                                           A) 8472B) 8626, 8626L10, 8627, 8627LC) 8637
2008/04/14   ######## 41771     Type III   6004013 SN AJ07080006, SN AJ07080007, SN AJ08010004
2008/04/14   ######## 41774     Type II               All Lot Numbers
                                           D7-L20-2515-RT, D7L102515RT
2008/04/14   ######## 41777     Type II                M7700
                                           A) A7700B) A) SN 21A554071J, SN 25A554143J, SN 27A555283J, SN
2008/04/14   ######## 41786     Type II                201-90220
                                           201-90160, All Serial Numbers
2008/04/14   ######## 41787     Type II    20451      N/A
2008/04/28   ######## 41792     Type II    10032746 113469, 115300, 115416
2008/04/28   ######## 39856     Type II    4759309 10255
2008/04/28   ######## 41842     Type II    SOP30THXXX 834402
2008/04/28   ######## 41844     Type II    2M86955 SRYB-0074, SRYB-0068, SYRB-0069, SYRB-0014, SYR
2008/04/28   ######## 41867     Type II               All
                                           55070, 55071 serial numbers SW ver 5.02
2008/04/28   ######## 41897     Type II               A) 60606342B) >100 Numbers,Contact ManufacturerC)
                                           A) 00-2555-030-05B) 00-5300-000-10, 00-5390-040-10C) 00-2500-0
2008/04/28   ######## 36667     Type I     AK-95, AK-95SHome Use (Update / Mise à jour )
                                                      All
 5/12/2008   ######## 41582     Type III   42-0056    478840, 475210
 5/12/2008   ######## 41772     Type II    1760       97552, 97574
 5/12/2008    4/4/2008 41858    Type II               A) 23431B) 23432C) 23433D) 23430E) 23430
                                           A) 146B) 147C) 148D) 145E) 145X
 5/12/2008   ######## 41183    Type II               A) >10 211, DWB 212, DWB 215, DWB 216, DWB 217
                                          A) DWB 210, DWBContact ManufacturerB) >10 Contact Manufactur
 5/12/2008   ######## 36188    Type I     N/A        Update / Mise à jour3233, 3279, 3715, 3234, 3194, 319
 5/12/2008   2/15/2008 41765   Type II               2772MCB) 2760KC) 2776D) 2782
                                          A) 2762CC,A) SN>10 Contact ManufacturerB) SN>10 Contact Manu
 5/12/2008   ######## 41995    Type II               700.21010, ERGOSCALE, ERGOSCALE-T, ERGOSCA
                                          700.05720, All Lots
 5/12/2008    4/3/2008 41996   Type II    N/A         Lot Numbers Beginning With M07LXX, M07MXX, M08A
 5/12/2008   3/19/2008 42021   Type I                 B) 9140-0000-0000
                                          A) 1-10-1-0 A) All units B) All units
 5/12/2008   ######## 42045    Type III   9006-24 59238M200
 5/12/2008   ######## 42049    Type II               N/A
                                          863071, 863072, 863073, 863074
 5/12/2008   ######## 42078    Type II    41509      N/A
 5/12/2008   ######## 41725    Type II               A) 20060605B) 20060605C) 20060605
                                          A) 7693B) 7692C) 7691
 5/12/2008   ######## 41875    Type II    TR9728     Batch # 106023
 5/12/2008   ######## 40156    Type II    N/A        SN 6024
 5/12/2008   ######## 40179    Type II               A) S/N 4045, S/N 4132B) S/N 7049C) S/N Not Provided,
                                          A) N/AB) N/AC) N/A
 5/12/2008   ######## 41754    Type II               A) MODEL H190, MODEL H195B) MODEL H199C) MODE
                                          A) H190, H195, H199B) N/AC) T165, T167, T175, T177D) A155E) 18
 5/12/2008   ######## 41456    Type II               A) P3600B) P3700AC) P3600D) P3700B
                                          A) N/AB) N/AC) N/AD) N/A
 5/12/2008   ######## 41577    Type II                01-0407B) 01-0401, 01-0406, 01-0410
                                          A) 01-0403,A) 051116, 051121, 030507B07, 052907E07, 060313C0
 5/12/2008    5/1/2008 41845   Type II    1.21E+10 17934401, 17934402
 5/12/2008   ######## 42024    Type II    820016     >10 serial # Contact Manuf.
 5/12/2008   ######## 42026    Type II    844001     CI0507B537, CI0405B549, CI0406B538, CI0206B659, C
 5/12/2008   ######## 42066    Type II    2700002 70080140
 5/12/2008   ######## 42071    Type II    723030     SS188D, SS188C, SS189A, SS189B, SS189C
 5/12/2008   ######## 42074    Type III              37333,
                                          OPCS03, OPCS05 37636, 37621, 37022, 37906, 37825, 37811, 377
 5/12/2008    5/2/2008 42075   Type II    210711     3069512
 5/12/2008    5/2/2008 42100   Type I     REF# 2FC12All FlexCath steerable sheaths
2008/05/26   ######## 41708    Type II    N/A        model / modèle P3930
2008/05/26   ######## 42027    Type III              All 12149435160, 12149443122,12149443160
                                          12149435122, Lot Numbers / Tous les numéros de lot
2008/05/26   ######## 42114    Type II               A) > 100 - Contact ManufacturerB) > 100 - Contact Man
                                          A) 00-7708-000-10, 00-7716-000-10B) 00-2195-012-00, 00-2195-01
2008/05/26   ######## 42116    Type II    1E69-03 54187M200
2008/05/26   ######## 34035    Type III   100 90 258 N/A
2008/05/26   ######## 41278    Type II               A) D01157,
                                          A) N/AB) N/AC) N/A D01100, D01166, D01400, D01401, D01406
2008/05/26   ######## 42070    Type III   SA9800     EA2288, EA2289, EA2291, EA2284, EA2292
2008/05/26   ######## 42072    Type III              A) 2224, 2319B) N/AE) 9401654F) 2667C) 2264D) 2473
                                          A) N/AB) N/AC) 09822693D)2459, 2589, 2616, 09401407G) 940150
2008/05/26   ######## 42118    Type III   DF34       FD8116, GC8128, BP8159, FK8187, FD8216, ES8244, CC
2008/05/26   ######## 42150    Type III              S
                                          OXY-2-SPD-1/N, D01775, S/N, D01638, S/N, D01749, S/N, D01845,
2008/05/26   ######## 42190    Type II    MP0801 Model mp0801, Lot 8063
2008/05/26   ######## 42021    Type I                A) All unitsB) All units
                                          A) 1-10-1-0B) 9140-0000-0000
2008/05/26   ######## 42115    Type II               A) 751884, 756011, 772804, 785026,
                                          A) SBA30MAXXXB) SOP30TKXXXC) SOP30ODXXX 790302, 820573, 8
2008/05/26   ######## 40955    Type II               07L026084, 07L026144, 07L026064, 07L062644, 08A01
                                          0240-050-988
2008/05/26   ######## 41566    Type II                8000-3303
                                          7650-3363, All Lots
2008/05/26   ######## 42120    Type III              All Lots
                                          207808, 207810, 207813, 207815, 207817, 208711
2008/05/26   ######## 42173    Type III              A) >10 Lots, Contact
                                          A) TR35WB) TSW35C) ATW35 Mfr.B) >10 Lots, Contact Mfr.C) >1
2008/05/26   ######## 42174    Type II               Serial
                                          MWCE-18-3.0-3- 1971324, 2063422
2008/05/26   ######## 42175    Type III   10033324 KAZ0682, KAZ0739, KAZ0742, KAZ0748, KAZ0750, KAZ0
2008/05/26   ######## 42068    Type II                003410510
                                          003409410,Various - contact Mfr.
2008/05/26   ######## 42076    Type II               10050C) 10033
                                          A) 10101B) A) All Serial NumbersB) All Serial NumbersC) All Serial N
2008/05/26   ######## 40792    Type II               A) All LotsB) All LotsC) All Lots
                                          A) 805355-020, 805355-021, 805355-022, 805355-023, 805355-02
2008/05/26   ######## 41991    Type II    AI-07155-IKRF8015920
2008/05/26 ########    42261   Type III   9-10424-18Lot 0624
  6/9/2008 ########    41727   Type II               N/A
                                          XRT 0401, XRT 0411
  6/9/2008 ########    42241   Type III   C01B       J7102403
  6/9/2008 ########    42251   Type III   TSX-301A/2N/A
  6/9/2008 ########    42046   Type III   8H00-01 N/A
  6/9/2008 ########    42274   Type II               A) N/AB)
                                          A) N/AB) N/AC) N/A N/AC) N/A
  6/9/2008 ########    42148   Type III   185687     Lot # 770293
  6/9/2008 1/8/2008    40492   Type II               A) All Lot Numbers Since LaunchB) All Lot Numbers Sinc
                                          A) 05004126B) 05004126
  6/9/2008 ########    41365   Type II    N/A        Serial 78925
  6/9/2008 ########    41781   Type II    8-5101-0 >10 Lot/Serial Numbers - Contact Manufacturer
  6/9/2008 ########    42273   Type II               N/A
                                          ISITE ENTERPRISE V.3.5, ISITE RADIOLOGY V.3.5, IVAULT V.3.5
  6/9/2008 ########    42336   Type II    N/A        Software Release 4.33.02, Software Release 4.34.02
  6/9/2008 ########    42166   Type II               A) 12597B) 13604
                                          A) 2400B) 2381
  6/9/2008 ########    41066   Type II    HL 30      100033, 100036, 100046, 100056, 100038, 14031007, 1
  6/9/2008 5/8/2008    42402   Type II    CB511      Lot# 9816345
  6/9/2008 5/2/2008    42069   Type II               04P158215 And Below, 03P158XXX All Lots, 04P158111
                                          003410-510, 003410-710, 0141080XXXC
  6/9/2008 3/9/2007    34524   Type II    2274023 S/N 82-0030
  6/9/2008 ########    39337   Type II    PROTIMEPST V50506, V52219, V55824, V56128, V56056
  6/9/2008 ########    42276   Type III   CCTNI-CR 637218002, 637281002, 637350002, 638035002, 6381
  6/9/2008 ########    40766   Type II               B) S5800YDC) 2320221, S1806JKD) 2320045-4, 232022
                                          A) S5800YF A) 00000438185BU1B) 00000442673BU0, 0000043434
  6/9/2008 ########    42410   Type III   N/A        All Lot Numbers
  6/9/2008 ########    42415   Type II               4023,
                                          0220-180-516 4105, 4158, 4360, 4524, 4585, 4740, 4862, 4880,
2008/06/23 ########    34637   Type II    5126671-2 All Serial Numbers
2008/06/23 ########    38366   Type II    QXCXXXX > 10 Lot Numbers - Contact Mfr.
2008/06/23 ########    39224   Type II               A) SN 823361B) SN 820646C) SN 824362
                                          A) SAN30LI'XXX'B) SNE30SPXXXC) SCV30CU'XXX'
2008/06/23 ########    39313   Type II               10018,
                                          7360717, 8139839 071206-W1, P011206-R1
2008/06/23 ########    39782   Type II    77 41 445 Service Pack 3
2008/06/23 ########    40741   Type III   N/A       >10 Serial Numbers - Contact Mfr.
2008/06/23 ########    40889   Type II    5117828 > 10 Lot Numbers - Contact Mfr.
2008/06/23 ########    41521   Type II    VA60A     12289, 13357, 13596, 13597, 13841, 1951
2008/06/23 ########    41532   Type II              A) 1158B) 4011, 4034C) 6037, 6038
                                          A) 4487070B) 1957153C) 5496984, 5496992
2008/06/23 ########    41341   Type II    N/A       R194025
2008/06/23 ########    41759   Type III   624922     N/A
2008/06/23 ########    41796   Type II    DC131      7HD066, 7KD027, 7LD012, 8AD049
2008/06/23 ########    42037   Type II              A) 381250B)
                                          A) 01-0575B) 01-0576 513250
2008/06/23 ########    42077   Type III             A) 2589B) 4063, 3042, 3158, 3191, 7360717E) 5857912
                                          A) 1940753B) 1940035, 4504200C) 9401654D) 3284, 3291,3295, 33
2008/06/23 ########    42163   Type II    N/A       > 10 Lot Numbers - Contact Mfr.
2008/06/23 ########    42277   Type II              A) > 453-0024-15B) - Contact Mfr. B) IR13390645, IR12
                                          A) 453-0024-14,10 Lot Numbers 067-A011-01, 067-A011-02, 067-A
2008/06/23 ########    42393   Type II    AXYS      EYZ4E, SN1081, SN1083
2008/06/23 ########    42401   Type II              < 125764
                                          MRT 5071, MRT 5111, MRT 5121
2008/06/23 ########    42562   Type III             All Serial Numbers
                                          02H30-01, 02H31-01, 91340-01, 91340-03, 91350-01, 91350-03
2008/06/23 ########    42566   Type III             A) CA12260006, CA12240081, CA12240082, CA122600
                                          A) M094-A002-01B) 073-B002-01C) 073-A021-01D) 073-A011-02
2008/06/232008-05-21
          
            42567   Type III   MMT-522 010387-C062, 010396-C062, 010404-C062, 010407-C06
2008/06/23 ########    42651   Type I               > 10 Lot Numbers -
                                          43400-XXXXXX, 99400-XXXXXX Contact Mfr.
2008/06/23 ########    42652   Type II              60577285, 60582624, 60587308, 60603255, 60610860
                                          00-5977-020-00
2008/06/23 ########    41441   Type II    C10040SL 13326414, 13327582, 13339106
2008/06/23 ########    42275   Type II              N/A
                                          9896 010 00612, 9896 010 00614, 9896 010 00615
2008/06/23   ########    42325    Type II   1.17E+10 All Lots
2008/06/23   ########    42403    Type III             A) >10 Numbers, Contact MfrB) 9884748, 9840678, 984
                                            A) 541T, 541T-R, 541TT, 541TT-RB) 511TC) TL3M35R14, TL3P79R8,
2008/06/23   ########    42682    Type III  5B73-20 All Lots
2008/06/23   ########    42691    Type II   N/A        Releases 1.0.0 Through 1.0.2
2008-01-07   ########    39358    Type ll   N/A        H500395, H500406, H500853, H501214, H501222, H50
2008-01-07   ########    39386    Type ll              All Lot Numbers
                                            1000459, 17-20902
2008-01-07   ########    39408    Type ll   8100LVP Units Distributed Before Sept. 27, 2007.
2008-01-07   ########    39421    Type lll  N/A        941343, 937351
2008-01-07   ########    39422    Type lll  270-2600 N/A
2008-01-07   ########    39423    Type ll   133, 133X 22422
2008-01-07   ########    39425    Type ll              20160232 (2x24), 20159931
                                            4625315017, 4625358017, 4625374190(1x24), lot exp apres 2008/
2008-01-07   ########    39426    Type lll  3.02E+09 All Lots / Tous les lots
2008-01-07   ########    39427    Type ll              A) N/AB) N/AC) N/AD) N/A
                                            A) 700.00525B) 700.00530C) 700.00510D) 88570101, ERGOLIFT-2+
2008-01-07   ########    39562    Type lll             N/A
                                            200-260-51, 200-261-51, 200-262-51
2008-01-07   ########    39575    Type ll               FD20
                                            Allura XPERS/N 297
2008-01-07   ########    39521    Type lll  N/A        N/A
2008-01-07   ########    39582    Type ll   A) MMC 2011B) MMC 2011
                                                       A) N/AB) N/A
2008-01-07   ########    39652    Type ll              > 5000:
                                            QD8100, QD8250 Contact Manufacturer
2008-01-07   ########    39352    Type ll   340487     98748
2008-01-07   ########    39405    Type ll              N/A
                                            367352, 368656
2008-01-07   ########    39695    Type ll   N/A        6023471, 7072998, 7116967
2008-01-07   ########    39272    Type ll              A) >100 Lot Numbers, Contact ManufacturerB) >100 Lo
                                            A) 5C4471, 5C4471RB) 5C8310, 5C8310P, 5C8310R
2008-01-07   ########    39388    Type ll   2C1071KJP >10 Lot Numbers, Contact Manufacturer
2008-01-21   ########    38032    Type lll             More
                                            65-3320, 65-3322than 100 - contact manufacturer
2008-01-21   ########    39781    Type II              A) All Serial Numbers / Tous les 09066916C) 078-A010-
                                            A) 04911855, 078-A001-14B) 078-A010-07,numéros de lotsB) All Se
2008-01-21   ########    39210    Type II              A) 0706211 Through 0709201B) 0706211 Through 138
                                            A) 138100, 138101, 138102, 138103, 138104, 138105, 138107, 070
2008-01-21   ########    39672    Type II              7
                                            SEY30CAXXX 177806 and 7088657, 7178690 and 7088612
2008-01-21   ########    38935    Type lll             178993-01, 178993-02, 179021-01,
                                            20751995190, 20752401190, 20753009190 179021-02, 179070
2008-01-21   ########    39231    Type II              A) AllB) All
                                            A) 6260-5-526, 6260-5-528, 6260-5-532B) 6260-9-526, 6260-9-528
2008-01-21   ########    39276    Type II              A) IAP-0500
                                            A) IAP-0400B) 070405V, 070411V, 070415V, 070420V, 70312V, 703
2008-01-21   ########    39700    Type lll  N/A        6287576
2008-01-21   ########    40034    Type lll  C-PLI-XXX 1928888, 1928896, 1935087, 1935095, 1958848, 1958
2008-01-21   ########    40047    Type II              A) SN A4622022, SN TSX-101A/EX, A5512058, SN TXS-
                                            A) TSX-101A/DX, TSX-101A/IXB) A4622037, SN TSX-101A/HXC)A551
2008-01-21   ########    40054    Type II   N/A        All Lots / Tous les lots
2008-01-21   ########    40091    Type I               S/N DN21566-H7, S/N DN21568-H7, S/N SA101569H7
                                            0998-00-3013-XX
2008-01-21   ########    38601    Type II              (Updated recall posted on posted on / Mise à jour d
                                            (Updated recall previously previously 2007-11-12 2007-11-12 / Mi
2008-02-04   ########    39226    Type I               N/A
                                            6485-3-311, 6485-3-313, 6485-3-315,6485-3-317
2008-02-04   ########    39555    Type II   N/A        All lots since October 2006. Lots > 20061000
2008-02-04    8/1/2005   37221    Type II   FR-093     30425, 30432
2008-02-04   ########    39668    Type II   STAR S4 IR 3237, 3228, 5819, 3367, 3340, 3026, 5638, 5136, 3249,
2008-02-04   ########    39757    Type II   1418246 All lots
2008-02-04   ########    39523    Type I    N/A        SN 732936067, SN 732936055
2008-02-04    7/6/2007            Type II   IB0900G 063169, 072216
                         40290Update-Previously Posted-2007-08-06 under recall # 36279 / Mise à jour - affiché
2008-02-04   ########    40104    Type II              A) 655-1386
                                            A) 655-1345B)30001014, 30001018B) 30001017
2008-02-04   ########    39755    Type II   01-3906 060403, 060615E06, 050228
2008-02-04   ########    40588    Type II   N/A        > 100 numbers - contact manufacturer
2008-02-18   ########    40302    Type I               A) 13173912 thru 13315455B) 13173912 thru 1331545
                                            A) 701-1-275, 701-10225, 701-10250, 701-10275, 701-10300, 701-
2008-02-18   ########    40619   Type II               A) All lot numbersB) All
                                            A) N/AB) N/AC) N/AD) N/AE) N/A lot numbersC) All lot numbersD
2008-02-18   ########    39231   Type II              N/A
                                            6264-8-526, 6264-8-528, 6264-8-532
2008-02-18    1/7/2008   39961   Type II              N/A
                                            37006, 37016, 37019, 37043, 37050, 37054, 37065, 530, C37236, C
2008-02-18    1/7/2008   40497   Type II    Model 8.0 N/A
2008-02-18    2/4/2008 40624     Type II              A) N/AB) N/AC) S/N 251564, S/N 251566
                                            A) OVBI112RB) 4000358.1204C) OVBI11
2008-02-18   ######## 39358      Type II    N/A        > than 10 numbers - contact manufacturer
2008-02-18   ########    40014   Type II    TD-SYN-01 V03.11.A, V03.11.B
2008-02-18   ########    40047   Type II               N/A
                                            TSX-101A/GX(Update/Mise à jour)
2008-02-18   ########    40457   Type II    N/A        151488, 151578
2008-02-18   ########    40682   Type III   DF21       FC8283
2008-02-18    1/7/2008   40744   Type I                N/A
                                            FT420T, FT430T
2008-02-18   ########    40543   Type II    6E44-20 48519M100, 51240M200, 58711M200
2008-02-18   ########    40557   Type II    08H00-01 SN> 20 Contact Manufacturer
2008-02-18    2/4/2008   40671   Type II    3D54-08 All lot numbers
2008-02-18   ########    40747   Type II               N/A
                                            MRT 7131, MRT 7161
2008-02-18    1/8/2008   40797   Type III   8H00-01 SN> 20 Contact Manufacturer
2008-02-18   ########    40826   Type II               A) 01H77-01
                                            A) 01H77-01B)LN 51754I2, LN 51749I2B) LN 51749I2, LN 51754I2
 3/3/2008    ########    40303   Type II               A) SN>10 Contact ManufacturerB) SN>10 Contact Manu
                                            A) V-242, V-243B) 430481C) V-193, V-193CD) V-268E) V-366, V-367
 3/3/2008     2/1/2008   40720   Type II    8604700 ARWM-0148, ARWM-0147, ARWM-0149
 3/3/2008    ########    40842   Type II              All Serial Numbers / Tous les numéros de série
                                            70-2006-9235-1
 3/3/2008    ########    40881   Type II              S/W version 1.2
                                            P/N 9055528-001, SC-7150
 3/3/2008    ########    40898   Type II    447280    M705441, M709279, M709319
 3/3/2008    1/14/2008 40639     Type II    N/A        All Lots
 3/3/2008    ######## 40874      Type III              J
                                            RE30950501018910, J018920, J101310, J101410, J101510
 3/3/2008    ######## 40885      Type II    100 90 679 92241, 93477, 95243, 95248
 3/3/2008    1/23/2008 37262     Type II    8355088 1019, 1083
 3/3/2008    ######## 38920      Type II    715280     LAB129A, LAB130A, LAB131A
 3/3/2008    ######## 39593      Type II    4244       2406181
 3/3/2008    ######## 39664      Type III              56480455, 56480465, 56480643, 56480657
                                            00-4836-090-00
 3/3/2008    ######## 39846      Type II               2403716, 2403684
                                            01.00181.420, 01.00181.440
 3/3/2008    ######## 40151      Type II    N/A        REL. 4.3.0 & 4.3.3 All Lots
 3/3/2008    ######## 40200      Type III              Various Lots
                                            00515042000, 00515047500, 00515048200,00515049500
 3/3/2008    ######## 40900      Type III              All Serial Numbers / Tous les numéros de série
                                            00-50004-0-101, 00-50004-0-102
 3/3/2008    ######## 40924      Type II               A) Work Order 828119B) Work Order 829807
                                            A) SBA30BLXXXB) SBA30BSXXX
 3/3/2008    ######## 40966      Type II               N/A
                                            GP 320000-00
 3/3/2008     2/8/2008 40969     Type III              S051511
                                            SU-20601, SU-20602
 3/3/2008    ######## 40972      Type II               Various Lot Numbers / Numéros de lot 00-2550-050-10
                                            00-2550-002-10, 00-2550-003-10,00-2550-004-10, variés
 3/3/2008    ######## 39425      Type ll    4625315017, 4625358017, 4625374190(1x24), 20158721 (1x6)
                                                       20160232 (2x24); 20159931
 3/3/2008    ######## 39811      Type ll               023X17 through/jusqu'à 122X17
                                            21-7001-24, 21-7002-24, 21-7100-24
 3/3/2008    ######## 41000      Type ll    1E07-20 42036HW00, 44084HW00, 45051HW00, 47055HW00, 5
 3/3/2008    ######## 41009      Type ll               All Serial Numbers / Tous 21-1711-02, 21-1711-50, 21-
                                            21-1701-50, 21-1702-50, 21-1703-50,les numéros de série
 3/3/2008    ######## 39359      Type III   DC114      7HD049
 3/3/2008    ######## 39678      Type ll    OWZD11 542849
 3/3/2008    ######## 41053      Type III              Various Lots / Lots variés
                                            00515002000, 00515002500, 00515003600
 3/3/2008     1/3/2008 40580     Type ll    7129534 10413, 10434, 10599
 3/3/2008    ######## 40725      Type ll    10057      57911, 57910
 3/3/2008    ######## 40899      Type III              ID098
                                            0066204, 0066214
  3/3/2008    3/3/2008   41048   Type ll               A) 308, 639, 62 671, 704, 642, 03 655 E392E, 65 22 5
                                            A) 64 54 800 E392EB) 64641,910 E392EC) 65 640, 330 B) 3241, 3243
 3/17/2008   ########    41072   Type II    939001     100272, 100354, 100073, 100238, 100263, 100211, 10
 3/17/2008   ########    38880   Type II    393-839 N/A
 3/17/2008   ########    40377   Type III   N/A        N/A
 3/17/2008   ########    40741   Type III   N/A        N/A
 3/17/2008   ########    41058   Type III              A) > 10 Numbers - 698, 698X, 699
                                            A) 694, 695, 695X, 696B) 697, Contact ManufacturerB) > 10 Numbe
 3/17/2008   2/22/2008 41091     Type II              1
                                            2-899-10036 0037, 10169
 3/17/2008   ######## 41117      Type III   N/A        All Serial Numbers / Tous les numéros de lot
 3/17/2008    2/8/2008 41136     Type II               S/N 1627, 2761, 2925
                                            AVOX1000E-110
 3/17/2008     1/8/2008 40097    Type II    5047       B/503726-907-2
 3/17/2008   ######## 41078      Type II               All P6000, P6001
                                            P1000, P1001, Serial Numbers
 3/17/2008   ######## 39441      Type III              A) Serial Number 144B) Serial Number 144
                                            A) 9732720B) 9732719
 3/17/2008   ######## 39661      Type II               N/A
                                            9200-0652A, 9200-0700A
 3/17/2008   ######## 39694      Type II               A) 9207, 4550 9186, 9200, 4550 110 02031D) 4550 11
                                            A) 4550 11004011B)9203, 110 02031C)9164, 9138B) SN>10 Contac
 3/17/2008    2/8/2008 40498     Type II    3.04E+09 Serial Numbers UJ33xxxxxx
 3/17/2008    1/9/2008 41089     Type II               S
                                            P150832355/N 070830-18-04, S/N 070830-18-01
 3/17/2008    3/3/2008 41167     Type II    87 28 581 1313, 1317, 1323, 1402, P0007130-0401006, P0007130
 3/17/2008   ######## 41193      Type II    NR7TCSIY All Lot Numbers / Tous les numéros de lot
 3/17/2008    3/3/2008 41242     Type II               A) Part #
                                            A) 862246B) 865047 862246B) Part # 865047
 3/17/2008   ######## 40777      Type II               A) 0710191, 0710231,
                                            A) 138107, 138110B) 139104EXT 0710232, 0710241, 0710242, 07
 3/17/2008    3/5/2008 41199     Type II    P60000     38A03D257
 3/17/2008    3/3/2008 41260     Type III              41550, 41540
                                            364, 365, 365X, 366
 3/17/2008   ######## 40983      Type II    2325660 All Lot Numbers / Tous les numéros de lot
 3/17/2008    3/6/2008 41256     Type II               R8322207-02
                                            RE13-101-001
2008/03/31   ######## 41080      Type II    N/A        All Lot Numbers / Tous les nuuméros de lot
2008/03/31   ######## 41330      Type II    712050     712050.2
2008/03/31   ######## 41183      Type II               A) >10 211, DWB 212, DWB 215, DWB 216, DWB 217
                                            A) DWB 210, DWBContact ManufacturerB) >10 Contact Manufactur
2008/03/31   ######## 41371      Type II    3180       AG06050004, AG06050054, AG06100030
2008/03/31   ######## 41362      Type II               A) 2589B) 3382C) 2427D) 7360717E) 5042E)
                                            A) 1940753B) 4504200C) 9401654 D) 5037, 5041,58579123796, 37
2008/03/31   ######## 41369      Type II                21-1701-81, 21-1703-62,
                                            21-1701-62,>10 Contact Manufacturer 21-1703-81, 21-1704-81, 21-1
2008/03/31   ######## 41374      Type II    122-800 K1107011
2008/03/31   ######## 41295      Type II               N/A
                                            MRT 7131, MRT 7161
2008/03/31   ######## 41296      Type II    XRT 1261 N/A
2008/03/31   ######## 37973      Type II               35061
                                            A) 35001B) A) All Lots / Tous les nuuméros de lotB) All Lots / Tous le
2008/03/31   ######## 41375      Type II               A) All Lots With Infrared
                                            A) LDXXXXB) 910XXXXC) 911XXXX OptionB) All Lots With Infrared
2008/03/31   ######## 41158      Type II               50723
                                            LAPL-K-HRP-001GM, LAPL-K-HRP-001M
2008/03/31   ######## 41317      Type II    N/A        H272299, H271662, H271651, H271161
2008/03/31   ######## 41348      Type III   N/A        No units in Canada / Aucune unité au Canada
2008/03/31   ######## 41318      Type I     N/A        H720702
2008/03/31   ######## 41349      Type III   N/A        No units in Canada. / Aucune unité au Canada
2008/03/31   ######## 41433      Type II    300-205 K0607007, K0707011, K0907004, K1007001, K1007004
2007-10-01   ######## 28447      Type III   MD712050 712050.014, 712050.015, 712050.016, 712050.017, 71
2007-10-01   ######## 37053      Type II    16395      15071
2007-10-01   ######## 37152      Type II               A) P21, All
                                            A) N31 B) P14,N/AB)P50 lot numbers / Tous les numéros de lot.
2007-10-01   ######## 37227      Type II               A) P0005408-0301009B)
                                            A) 8415957B) 8728854C) 87 28 581 1394 C) 1313, 1317, 1323, 140
2007-10-01   ######## 37496      Type III   N/A        N/A
2007-10-01   ######## 37585      Type III              7126
                                            CCNRP-05, CCNRP-10
2007-10-01 ########    32132   Type lll   719510     RA539
2007-10-01 ########    32300   Type lll   N/A        185091, 195101                                      .
2007-10-01 ########    37628   Type lll   15196      610333, 701034, 704053, 707222
2007-10-01 ########    37635   Type lll              A) Software Version 7.4SP1B) Software Version 7.4SP1
                                          A) 420334.974SP1B) 420334.974SP1
2007-10-01 ########    37486   Type II    137000     000026, 030046, 000037, 000097, 010026, 010077, 20
2007-10-01 ########    37610   Type II    228811     6250885, 6311396
2007-10-15 ########    31836   Type lll               R0048, R0045
                                          942-890, 942-892, 942-893- R0050, R0058 - R0063
2007-10-15 ########    37219   Type lll              10065
                                          66001710, 66018222
2007-10-15 ########    37152   Type ll               A) All Serial
                                          A) P14, P21, P50B) N31 NumbersB) All Serial Numbers
2007-10-15 ########    37632   Type ll               2469, 2473, 2475, 2476, 2559, 2618, 2459, 2589, 2616,
                                          1940035, 1940753, 4504200, 9401407, 9401506, 9401654, 982268
2007-10-15 ########    37747   Type lll              A) 3042, 3158, 3191, 3284, 3291, 3295, 3356, 3378, 338
                                          A) 4504200B) 7360717C) 5857912
2007-10-15 ########    37749   Type ll    8419009 1064, 1353, 1408, 1512
         2
2007-10-15006-03-031   31115   Type l                A) >10, Contact ManufacturerB) >10, Contact Manufact
                                          A) 04540808001, INF 04540824001,            INF 04540867001, INF 0
2007-10-15 ########    37323   Type ll               A) All LotsB) All LotsC) All 02790309C) 02789602, 0279
                                          A) 02789602, 02790309B) 02789602,Lots
2007-10-15 ########    37825   Type ll               A) 3376, 4063, 70-4111, 2589, 3042, 3158, 5857912
                                          A) 1940035, 4504200, 9401654, 9822685B) 7360717C)3191, 3284,
2007-10-15 ########    28447   Type lll   MD712050 712050.014, 712050.015, 712050.016, 712050.017, 71
2007-10-15 ########    36866   Type lll              Version R01.0016, Version R02.00.17, Version R02.01.0
                                          R01.00.16, R02.00.17, R02.01.05
2007-10-15 ########    37944   Type lll   860284     N/A
2007-10-15 ########    37954   Type ll               All Serial
                                          4R4580, 4R4580R Numbers
2007-10-15 ########    37506   Type l     99825-20 05K059D
2007-10-15 ########    38098   Type lll   N/A         N/A
2007-10-15 ########    37878   Type ll               >1000 Numbers Contact Manufacturer
                                          88944520, 88944525, 88944530, 88944535, 88944540, 88944545,
2007-10-29 ########    37658   Type ll    5583705 22BO6078, 22KO6124, REPG0035, REPL0298
2007-10-292007-09-26
           
           38257   Type lll   N/A        689804, 689805, 789801
2007-10-292007-09-26
           
           38258   Type ll    N/A        714362, 716129, 718258, 519096, 521487, 616274, 617
           

2007-10-292007-10-05   38303   Type l                 2M8163, DMN8153B) 2M9163C) DNM9163
                                          A) 2M8153,A) All Serial Numbers / Tous les numéros de sérieB) All S
2007-10-29 ########    37067   Type ll               A) 249524B) 249583
                                          A) H 56102B) S 1811
2007-10-29 ########    38251   Type ll               A) N/AB) N/A
                                          A) MRT 6001, MRT 6011B) MRT 10601
2007-10-29 ########    38254   Type ll    N/A        N/A
           

2007-10-292007-07-25   38404   Type ll    N/A        1201291, 1201431
2007-10-29 ########    38405   Type ll    N/A        Part no. 973100
2007-10-29 ########    38406   Type ll    N/A        102809K, 102810K, 100166K, 100167K
2007-10-29 ########    38407   Type ll    N/A        All Serial Numbers
2007-10-29 8/4/2006    32271   Type ll               >100 Serial Numbers Contact Manufacturer / 100 CICV
                                          CICV3APRO-X, CICV3APRO=XXX, CICV3APRO=XXX/XXX , numé
2007-10-29 ########    37291   Type ll    944-069 17323 in Canada 18700,18125,8513,18533,18552,1857
2007-10-29 ########    36658   Type ll    2259988 >100 Serial Numbers Contact Manufacturer / 100 numé
2007-10-29 ########    37771   Type ll               A) V96 series, B10 seriesB) V96 series
                                          A) 198-0301-00B) 198-0302-00
2007-10-29 ########    38113   Type lll   1.21E+10 69087701
2007-10-29 7/1/2007    38136   Type ll    H48651PT S/N D00161, D00162, D00164, D00229, D00329, D0037
2007-10-29 ########    38159   Type ll    C100       N/A
2007-10-29 ########    38435   Type l                A) All Serial Numbers 430880
                                          A) 194981B) 194980C) 430881D) / Tous les numéros de sérieB) All S
2007-11-12 ########    38111   Type ll               All Lot # Since
                                          900001, 900006, 902040 1999
2007-11-12 ########    38427   Type lll              R193018,
                                          B1029-86, B1029-86AR193017
2007-11-12 ########    38434   Type lll   1E46-02 505017
2007-11-12 ########    38437   Type lll              2380677
                                          01.00214.054
2007-11-12 9/7/2007    37147   Type ll               A) N/AB)
                                          A) N/AB) 30859602 P921410, P921420, P921430, P920810, P9179
           

2007-11-122007-09-13   38376   Type ll               Ver 4.0.2 To 5.2.1
                                          339455, 343926, 343928, 347526, 347527
2007-11-12    8/8/2007   38431   Type ll    SSA-550A SN>20, Contact Manufacturer
2007-11-12   ########    38432   Type ll    SSA-790A SN>80, Contact Manufacturer
2007-11-12   ########    38444   Type ll    801046     0049, 0079
2007-11-12   ########    38539   Type lll   N/A        618119, 619802, 713410, 716130, 716954, 717708, 71
2007-11-12   ########    38546   Type ll    N/A        N/A
2007-11-12   ########    35636   Type II               N/A
                                            Updated recall # 35636 previously posted on 2007-06-25. Mise à jo
2007-11-12   ########    38476   Type II    7D63-30 52044HW00, expiry - 2007/10/19
2007-11-12   ########    38479   Type II               A) N/AB) N/AC) N/A
                                            A) 0031100B) 0031030, 0031050, 0031070, 0033080, 0033100, 00
2007-11-12   ########    38529   Type II    7L01-01 N/A
2007-11-12   ########    38617   Type lll   900321     P060928
2007-11-12   ########    38628   Type II               07B069, 07B070,
                                            1500949, 1500950, 1500951 07B071
2007-11-12   ########    34805   Type II               A) 7360717C) 3407, 3638, 3919, 3641, 3742, 3042, 31
                                            A) 4504200B) 3382, 3406,5857912
2007-11-12   ########    38139   Type lll              60680123
                                            00-5755-016-02
2007-11-12   ########    38678   Type II    N/A        > 100 Lots, Contact Manufacturer
2007-11-12   ########    38601   Type II               A) 2589, 3158, 3284, 3356, 3619,
                                            A) 1940753, 4504200, 9822685B) 5857912 2667, 2224B) 3799
2007-11-12   ########    38619   Type II               97266
                                            06484105, 1760
2007-11-12   ########    38357   Type II    N/A        Model 240 Blue & 242 Blue
2007-11-12   ########    38621   Type lll              A) 78102B) 10009, 10012,
                                            A) 07333680B) 07351898C) 8139839 10013, 10014, 10015, 10016
2007-11-26   ########    38669   Type ll               A) >
                                            A) 7426B) 7428 10 devices, contact manufacturerB) > 10 devices, c
2007-11-26   ########    38744   Type ll    6.2E+08 26208600
2007-11-26   ########    37486   Type ll    137000     000026, 030046, 000037, 000097, 010026, 010077, 02
2007-11-26   ########    32105   Type ll    M3001A > 100 serial numbers, contact manufacturer
2007-11-26   ########    38502   Type ll    P3200      E3222AD0046-H023AD6179
2007-11-26   ########    38822   Type ll               A) 06F05-01C) 06F07-01D) 06F08-01E) A07054, A0709
                                            A) 06F04-01B)A07110, A07153B) A06310, A07053, 06F09-01F) 06F
2007-11-26   ########    36689   Type ll               A) 2351505, 5131070B) manufacturerB) > 10 numbers
                                            A) 2259988-2, > 10 numbers, contact2259988-2, 2351505, 5131070
2007-11-26   ########    38804   Type ll               Version 2.1 and later
                                            337032, 339459, 339460, 339461, 343323, 343324
2007-11-26   ########    38813   Type ll    3.5E+09 18008200, 13927900
2007-11-26   ########    38214   Type l                A) > 10 numbers, contact manufacturerB) > 10 numbe
                                            A) N/AB) 2378698-2C) 2378698-2
2007-11-26   ########    38452   Type lll              3022532, 3037536, 3062548, 3079392, 3135003, 3225
                                            366357, 366359
2007-11-26   ########    38823   Type lll   462, 462X 66540
2007-11-26   ########    38894   Type lll              S/N VS3007338, S/N VS3007336, S/N VS3007635,S/N V
                                            1018336, 1018753, 1019370, 1020175, 701-01000-00,V1000
2007-11-26   ########    38812   Type lll   1.17E+10 178500XX
2007-11-26   ########    38314   Type ll    N/A        07CD1090, 07DD3113
2007-11-26   ########    38700   Type ll               A) 7026715, 7087667, 7120126, 7016462, 7144536B) 7
                                            A) 299108B) 299107
2007-11-26   ########    38620   Type l                NA039574, NA039592, NA038374, NA039604, NA0375
                                            970302E, 970311-E
2007-11-26   ########    38884   Type l     N/A        25622
2007-11-26   ########    38941   Type ll    AT-120124 GFRF1789
2007-12-10   ########    38915   Type ll               A) 53190Q100, 53190Q101 B) 51187Q100
                                            A) 7A65-20B) 9512-60
2007-12-10    9/7/2007   38921   Type ll    TSX-021A S/N > 20, Contact Manufacturer / Contacter le manufac
2007-12-10   ########    38976   Type ll               A)
                                            A) N/AB) N/A ASP 105, ASP 110, ASP 125, ASP 135, ASP 145, ASP 1
2007-12-10   ########    34083   Type lll              A) >10 Devices Contact Manufacturer
                                            A) C60A2UB) T60A1C) T70A1D) C60A1E) C50A1 / Contacter le ma
2007-12-10   ########    38741   Type ll    BIB2003-01>100 numbers Contact Manufactuer / Contacter le man
2007-12-10   ########    38975   Type ll    M3170      S/N 4721A01711
2007-12-10    8/7/2007   37977   Type ll    35061      Various / See Manufacturer             Divers / Voir m
2007-12-10   ########    38472   Type ll               A) 79927A, 81083AB) 79873AC) 81354A, 81344A, 8147
                                            A) 960630, 960640B) 962131C) 960440, 960441, 960452, 960453,
2007-12-10   ########    38840   Type ll               N/A
                                            842-326, 842-327, 842-328, 902-754, 905-671
2007-12-10   ########    38953   Type ll    5DCD       D4HZ9Y
2007-12-10   ########    39055   Type ll                7144-0412, 7144-1111, 7144-1112,7144-1144
                                            7144-0012, N/A
2007-12-10   ########    39116   Type ll                 5791
                                            5773, 5785,2495, 2571, 2987, 3021, 3179, 3190, 3192, 3289, 3341,
2007-12-10   ########    39152   Type lll   N/A         N/A
2007-12-10   ########    38444   Type ll    801046      0049, 0079
2007-12-10   ########    39051   Type l                 >10 serial #'s, contact manufacturer /
                                            10012-2555-001                                           contacter le
2007-12-24   ########    35462   Type III               All
                                            03H53-01, 03H53-03, 03H57-01, 03H57-03
2007-12-24   ########    35589   Type II                A) N/AB) N/AC) N/AD) N/AE) N/AF) N/AG) N/AH) N/AI)
                                            A) L-3SDC, L-4DC, L-5DC, L-6DC, M-15SDC, M-1SD, M-2B, M-2DC, M
2007-12-24   ########    37157   Type II    N/A         N/A
2007-12-24   ########    38922   Type II    N/A         N/A
2007-12-24   ########    39250   Type II                A) A2622022, A4622037, A5512058, A5512066,
                                            A) TSX-101A/DX, TSX-101A/IXB) TSX-101A/EX, TSX-101A/HX ICA068
2007-12-24   ########    39283   Type II                A)
                                            A) N/AB) N/A N/AB) N/A
2007-12-24   ########    39284   Type II    N/A         M705222, M706238
2007-12-24   ########    39285   Type III   N/A         N/A
2007-12-24    7/4/2007   39286   Type II                A)
                                            A) N/AB) N/A Software version 2.2B) Software version 2.1
2007-12-24   ########    39288   Type II                A)
                                            A) N/AB) N/A N/AB) N/A
2007-12-24   ########    39136   Type III   VP8500      06082385, 06082485, 06982285
2007-12-24   ########    39332   Type III   N/A         N/A
2007-12-24   ########    34244   Type II                A) N/AB) N/AC) N/A
                                            A) 667M, 668MB) 680M, 685MC) 670M
2007-12-24   ########    39245   Type II    4759309 10255
2007-12-24   ########    39364   Type II    20902       000025681, 000025622, 000025491, 000025253, 0000
2007-12-24   ########    37486   Type II                000026, 010026, 020026, 030046, 040016, 000037, 00
                                            137 001 000, 137000
2007-12-24   ########    38884   Type l     N/A         All Lots / Tous les lots
2007-12-24    2/2/2007   34564   Type II                A) Contact Manufacturer / >10
                                            A) 006689-901, 006689-903B) TRU5-32 numéros, contacter le m
2007-12-24   ########    39223   Type II    1603        SN< OR = 900293, SN< OR = A14927, SN BEGINNING W
2007-12-24   ########    39236   Type II    LM8035 SN 46675, SN 44711
2007-12-24   ########    39341   Type l                 A) >10 numbers, Contact Manufacter / >10 numéros, co
                                            A) 777003-005, 777003-215B) 777800-400
2007-12-24   ########    39374   Type II    TD-SYN-01 N/A
2007-12-24   ########    39411   Type III               10050C) 10033
                                            A) 10101B) A) All Serial Numbers / Tous les numéros de sérieB) All S
2007-12-24   ########    38823   Type III               66540, 66970
                                            462, 462X, 463, 463X
2007-08-20   ########    31672   Type III               A) 2003L27E, 2004F06E, 2004J03E, 2004I14EB) 2003F3
                                            A) I-MPEOC-35B) I-MPEDC-30, I-MPEDC-35, I-MPEDC-40, I-MPEDC-
2007-08-20   ########    33981   Type II    801041      0030, 0033, 0034, 0036-0038, 0041-0043, 0045-0049, 0
2007-08-20   ########    33982   Type II                A) 0011-0039, 0041-0500B) 0036, 0045, 0047, 0055, 00
                                            A) 801763B) 802100
2007-08-20   ########    33980   Type III   801763      0011-0500
2007-08-20   ########    33984   Type II                A) 0029-2083, 0030-2205B) 0032-0380
                                            A) 801040, 801041B) 801046
2007-08-20   ########    33985   Type II    N/A         0067-0896
2007-08-20   ########    36651   Type III               60457880
                                            00-7850-015-00
2007-08-20   ########    36652   Type II                N/A
                                            A) MMT-512, MMT-515, MMT-712, MMT-715B) MMT-522C) MMT
2007-08-20   ########    36660   Type III   4R5707      All serial numbers not listed in the technical service bul
2007-08-20   ########    36673   Type II                0029-2083, 0030-2205
                                            801040, 801041
2007-08-20   ########    33831   Type II    305282      6073436
2007-08-20   ########    33951   Type II    N/A         65857
2007-08-20   ########    34210   Type II    N/A         6167435
2007-08-20   ########    36667   Type I                 All
                                            AK-95, AK-95S serial numbers
2007-08-20   ########    36684   Type I     6.02E+09 All serial numbers
2007-08-20   ########    36696   Type II                A) 164300B) 164268C) 16400
                                            A) N/AB) N/AC) N/A
2007-08-20   ########    36730   Type III               03307, 12226, 03307A, 03307B, 08096
                                            DSL-5600, DSL-5606
2007-08-20   ########    28383   Type II    453567073191, 455011004011,
2007-08-20   ########    28852   Type II    227761      4293914
2007-08-20   ########    31203   Type I     H190        311769, 311852, 311884, 311743
2007-08-20    3/8/2007   34506   Type II                Sealex Extra
                                            Eucalyptol, 2205, 3150 Kit, Sealex Extra Liquid, Sealex Extra Powde
2007-08-20   ########    36531   Type II                N/A
                                            A) 200388, 200392, 247004, 248009 B) 200388, 200392C) 247001,
2007-08-20    3/5/2007   36629   Type II    6551386 DR30001014, DR30001017
2007-08-20   ########    36668   Type II                A) ISM12H, ISM12JB) SR1C, SMG, SS3A, SU91, SS3B, SX7
                                            A) REF-900220B) REF-900218
2007-08-20   ########    36728   Type III               45540, 45541, 45542, 45543
                                            694, 695, 695X, 696
2007-08-20   ########    36731   Type III               0
                                            DSL-10-90001036-C
2007-08-20   ########    36733   Type III   A13422      615647, 617413, 618502, 618504, 713878, 713880, 71
2007-08-20   ########    36735   Type II                A) Software
                                            A) 626553B) 626554 Version 2.2 / Version du logiciel 2.2B) Softw
2007-08-20   ########    36749   Type II                A)
                                            A) N/AB) N/A N/AB) N/A
2007/04/02   ########    33329   Type II                All
                                            1006236-001 Serial Numbers using software Version 5.2. / Tous le
2007/04/02   ########    33344   Type II                A) 353147CN2, 353577CN0, 328083CN, 346495CN5, 36
                                            A) 2357739, 2357739-4, 2357739-8B) 5124069C) 5126093
2007/04/02   ########    33345   Type II                 B) 5126093
                                            A) 5124069A) > 10 lot numbers, contact manufacturer./ >10 numér
2007/04/02   ########    33910   Type II                N/A
                                            22105-68, 22105-69
2007/04/02   ########    34046   Type III   8435307 1750, 1860
2007/04/02   ########    34277   Type II    3500        N/A
2007/04/02   ########    34305   Type II    N/A         N/A
2007/04/02   ########    34404   Type III               42462M100, 42462M101
                                            2K25-20, 2K25-25
2007/04/02   ########    34484   Type II                All lot numbers. / Tous les numéros de lot.
                                            7209166, 7209167
2007/04/02   ########    34484   Type II                A) 86-0194, 86-0266, P4-0060-R, 86-0182, 86-0018, 86-
                                            A) N/AB) N/AC) N/AD) N/A*********************************
2007/04/02   ########    34499   Type II                A)
                                            A) N/AB) N/A 453567005721B) 453567073191
2007/04/02   ########    34519   Type II    N/A         N/A
2007/04/02   ########    34521   Type II                A)
                                            A) N/AB) N/A N/AB) N/A
2007/04/02   ########    34531   Type III   RF421C      GF7353
2007/04/02   ########    32636   Type II    V2.60       914-418, 914-426
2007/04/02   ########    34447   Type III               A) N/AB) 18 363, 018 18 454
                                            A) 018 18 447B) 018 N/A
2007/04/02   ########    34448   Type II    08355088 N/A
2007/04/02   ########    34280   Type II    CV 6100K PX018A
2007/04/02   ########    34313   Type II                A) N/AB) N/A
                                            A) N/AB) Impax 4.5, Impax 5.0, Impax 5.2
2007/04/02   ########    34516   Type I                 N/A
                                            4-070550-SP, 4-840120DICU-EN
2007/04/02   ########    34543   Type II    263739      1703510
2007/04/02   ########    32004   Type II                A) 00000002585VE8B)
                                            A) N/AB) N/AC) N/AD) N/AE) N/A 00000001562VE8, 00000088502
2007/04/02   ########    33498   Type II    714508      56510483
2007/04/02   ########    34069   Type II    3770GK B0228500K, B0262527K
2007/04/02   ########    34089   Type II    N/A         M0034942030
2007/04/02   ########    34293   Type III               A) N/AB) N/AC) N/AD)
                                            A) N/AB) N/AC) N/AD) N/AE) N/A N/AE) N/A
2007/04/02   ########    34513   Type II    2350023 > 10 lot numbers, contact manufacturer./ >10 numéros
2007/04/02   ########    34514   Type II    N/A         > 10 lot numbers, contact manufacturer./ >10 numéros
2007/04/02   ########    34517   Type II    N/A         > 10 lot numbers, contact manufacturer./ >10 numéros
2007/04/02   ########    34532   Type III   9K08-20 42249HN00, 42249HN01, 43528HN00, 43528HN01
2007/04/02   ########    34536   Type II    N/A         N/A
2007/04/02   ########    34549   Type I                 DDU-100E
                                            DDU-100A, 101001000 - 101025955, 112001001 - 112002242, 116
2007/04/02   ########    34553   Type III               11455C006, 11605UN06, 12072UN06, 14818UN06, 130
                                            2K41-20, 2K41-25, 2K41-30
2007/04/02   ########    34565   Type II    N/A         SCH-64701
2007/04/02   ########    34566   Type II    N/A         410636H, 392236H, 37117-6H, 341606H
2007/04/02   ########    34595   Type II    N/A         N/A
2007/04/02   ########   33615   Type II    N/A        All serial Numbers. / Tous les numéros de série.
2007/04/02   ########   33616   Type II    N/A        All serial Numbers. / Tous les numéros de série.
2007/04/02   ########   34214   Type II    N/A        M02PT4023LLC , M02PF4022B, M02P4022WMH, M02P
2007/04/02   ########   34510   Type I                2516Z: Y040605-1, 2516Z: Y040605-2, 2516Z: Y052605
                                           2516M, 2516Z
2007/04/02   ########   34518   Type II    2FC12      00017, 00036, 00070, 00085, 00170, 00277, 00344, 003
2007/04/16   ########   33213   Type II    N/A        > 10 lot numbers, contact manufacturer./ >10 numéros
2007/04/16   ########   34291   Type III              A)
                                           A) N/AB) N/A N/AB) All lot numbers. / Tous les numéros de lot.
2007/04/16   ########   32295   Type III              3
                                           0623-703-01912, 4011, 4116
2007/04/16   ########   33305   Type III   8637       N/A
2007/04/16   ########   34068   Type II    REM1860 610707, 0614409, 0614411
2007/04/16   ########   34216   Type III   32-191025 79500
2007/04/16   ########   34303   Type II    N/A        CN:8065-9000-13,SN: L6N2075S
2007/04/16   ########   34474   Type III   71687029 493645, 493645A, 493645B, 493645C, 493645E
2007/04/16   ########   34475   Type III              All
                                           20737836322 lot numbers. / Tous les numéros de lot.
2007/04/16   ########   34613   Type II    N/A        N/A
2007/04/16   ########   34674   Type III   368652     5236082
2007/04/16   ########   34685   Type III   N/A        N/A
2007/04/16   ########   34687   Type II               6158973, 6164128, 6153297, 6215941,
                                           376100, 376300, 376400, 376500, 376700, 376900 6159927, 6312
2007/04/30   ########   34240   Type III              A) 485757,
                                           71674002, 71674003 485758B) 485757, 485758C) 485757, 48575
2007/04/30   ########   34562   Type I     N/A        N/A
2007/04/30   ########   34726   Type II    N/A        07M15751
2007/04/30   ########   34743   Type III   2L3100     16110188SR, 17010006SR, 16110183SR, 16120317SR,
2007/04/30   ########   34787   Type II                2M8163B) 2M9163C) 2M8161
                                           A) 2M8153,A) 11120044TC, 12040151TC, 12070377TC, 12070776T
2007/04/30   ########   34318   Type II               APPLIO 80,
                                           SSA-700A, SSA-770A APPLIO 50
2007/04/30   ########   34527   Type III   280135     Z107LB
2007/04/30   ########   34587   Type II    N/A        N/A
2007/04/30   ########   34725   Type II               A) N/AB)
                                           A) N/AB) N/AC) N/A N/AC) N/A
2007/04/30   ########   34747   Type II    N/A        N/A
2007/04/30   ########   34748   Type II    7A12-60 45050Q100
2007/04/30   ########   34749   Type III   00518      052783, 061242, 061981
2007/04/30   ########   34784   Type II               A) N/AB) N/AC) N/AD) N/AE)
                                           A) N/AB) N/AC) N/AD) N/AE) N/AF) N/A N/AF) N/A
2007/04/30   ########   34789   Type II               A) N/AB) N/AC) N/AD) N/AE) N/AF) N/AG) N/AH)
                                           A) N/AB) N/AC) N/AD) N/AE) N/AF) N/AG) N/AH) N/AI) N/A N/AI)
2007/04/30   ########   34791   Type II    N/A        M3860A, M3861A
2007/04/30   ########   34792   Type II    N/A        N/A
2007/04/30   ########   34794   Type II    N/A        21-7381-01, 21-7383-01, 21-7394-01
2007/04/30   ########   34796   Type III   2224, 2225 09822
2007/04/30   ########   34797   Type III   09-0394 0207B07, 022807B07
2007/04/30   ########   34813   Type III   N/A        All lot numbers. / Tous les numéros de lot.
2007/04/30   ########   34814   Type III   N/A        M604191
2007/04/30   ########   34815   Type III   N/A        All lot numbers. / Tous les numéros de lot.
2007/04/30   ########   34837   Type III   N/A        33069, 22306
2007/04/30   ########   34838   Type II    N/A        MCT 9471
2007/04/30   ########   34841   Type III   N/A        7036
2007/04/30   ########   34849   Type III              N/A
                                           KMBB4OSU2FUS
2007/04/30   ########   34684   Type II    N/A        8468, 9084
2007/04/30   ########   34859   Type II    4000526 Software Release 1.23.3
2007-05-14   ########   33552   Type II               AETK28031
                                           1107-9612-000
2007-05-14   ########   34525   Type II    N/A        80291MA8, 996494WK1, 995378WK7, 996793WK6, 99
2007-05-14   ########   34593   Type II    N/A        E9-0148, E9-0027, E2-7026MH, E2-0065, E2-0073, E9-0
2007-05-14   ########   34645   Type II    1006236-001IT35226P, IT35079, IT35214P, CS535P, IT35071
2007-05-14   ########   34646   Type II               A) N/AB) N/A
                                           A) 5126671-2B) 2341727
2007-05-14   ########   34728   Type II    1006236-001IT35226P, IT35079, IT35214P, CS535P, IT35071
2007-05-14   ########   34731   Type II    1006236-001IT35226P, IT35079, IT35214P, CS535P, IT35071
2007-05-14   ########   34795   Type II    71353255 06DT97293
2007-05-14   ########   34840   Type II    N/A        All lot numbers / Tous les numéros de lot.
2007-05-14   ########   34868   Type II               0605031 to 0612141
                                           000341, 000342, 000343, 000344, 000345, 000379, 000380, 00044
2007-05-14   ########   34916   Type III              CGR8496B
                                           CGR8448B, All lot numbers / Tous les numéros de lot.
2007-05-14   ########   34918   Type II               06361AE2 Thru 07044AE2
                                           0279-351-100
2007-05-14   ########   34958   Type II    118-305 L 61121
2007-05-14   ########   34992   Type I                Serial
                                           14086-2550-000 numbers < 10746
2007-05-14   ########   33870   Type II               A) 769528, 781014B)
                                           A) SCV30OHXXXB) SCV30PCXXX 778976, 787188
2007-05-28   ########   34511   Type I     N/A        N/A
2007-05-28   ########   34537   Type III   7B39-20 N/A
2007-05-28   ########   34875   Type I                N/A
                                           0449105190, 04491041190
2007-05-28   ########   35002   Type III   N/A        061020
2007-05-28   ########   35003   Type II               All lot numbers. / Tous N/A
                                           A) N/AB) N/AC) N/AD) N/AE) N/AF)les numéros de lot.
2007-05-28   ########   35006   Type III   N/A        6139630, 7059245
2007-05-28   ########   35008   Type II               All lot numbers.
                                           A) N/AB) N/AC) N/AD) N/A / Tous les numéros de lot.
2007-05-28   ########   34059   Type II    N/A        > 10 lot numbers, contact manufacturer. / > à 10 numé
2007-05-28   ########   34837   Type III               1686, 22306
                                           1683, 1684,33069, 1690, 1691, 1692, 1693, 1694
2007-05-28   ########   34982   Type III   P1350      222575-1-10, Exp-Feb 19/07
2007-05-28   ########   34985   Type III   T7666      222364-1, Exp-May 13, 2007
2007-05-28   ########   34276   Type II    N/A        N/A
2007-05-28   ########   34621   Type II    N/A        06I01203, 06I01027
2007-05-28   ########   34652   Type II    N/A        N/A
2007-05-28   ########   34782   Type II               > 100 lot numbers, contact manufacturer. / > à 100 num
                                           A) 700-102615B) 700-101493C) 700-101317
2007-05-28   ########   34874   Type II               60883401, 60875349, 60875345, 60869466, 60861993
                                           375196, US3130
2007-05-28 ######## 34935       Type I     1949882    3151, 3170
2007-05-28   ########   35032   Type II    N/A        > 1,000 lot numbers, contact manufacturer. / > à 1,000
2007-05-28   ########   35043   Type III   P1174      229957-1 Expiry Date May 17, 2007
2007-05-28   ########   35079   Type III              All booklets
                                           A) 010-693B) 010-549 since 2004. / Tous les livrets depuis 2004
2007-05-28   ########   35094   Type II    N/A        N/A
2007-05-28   ########   34917   Type II               33021C) 33112
                                           A) 33007B) A) 20040285613 to/à 20060269563, 20060284896 to/à
2007-05-28 ######## 35153       Type III   OSR6133 4355, 4552, 4224
2007-05-28   ########   35161   Type III              061312,
                                           09F29-20, 09F29-25 061313, 062633, 063281, 063282
2007-05-28   ########   35134   Type III   1.19E+10 All lot numbers. / Tous les numéros de lot.
2007-05-28   ########   35215   Type II               A) N/AB) N/AC) N/AD)
                                           A) N/AB) N/AC) N/AD) N/AE) N/A N/AE) N/A
2007-06-11   ########   34824   Type III               9C21-50B)1A06-22
                                           A) 7A59-22,N/A
2007-06-11   ########   35137   Type III              All 177331-01
                                           11731297122, lot numbers. / Tous les numéros de lot.
2007-06-11   ########   35138   Type III   1.2E+10 All lot numbers. / Tous les numéros de lot.
2007-06-11   ########   35000   Type III              A) 48839M100, 50450M100, 51252M100B)
                                           A) 5C78-20B) 3B23-20 C) 3B41-20D) 3C81-20E) 2J44-20 49146M10
2007-06-11   ########   35132   Type II    63747      7C1025
2007-06-11   ########   35222   Type III   52040      47825RY
2007-06-11   ########   34533   Type II    160-300 K0304001, K0704002, K1103005, K0604003, K0404001
2007-06-11   ########   34682      Type III              09040003, 06060009, 08060239
                                              300-337, 300-350, 300-351, 320-000
2007-06-11   ########   34820      Type II    N/A        L300107, L300379, L300502, L300396, L300452, L3003
2007-06-11   ########   34829      Type II               A) 600TB) N/A
                                              A) 600C, 600F,N/AB) N/A
2007-06-11   ########   35223      Type II               A)
                                              A) N/AB) N/A N/AB) N/A
2007-06-11   ########   35387      Type III              N/A
                                              338572, 339870, 640271, 640971
2007-06-11   ########   35416      Type III   N/A        N/A
2007-06-11   ########   35426      Type III   N/A        N/A
2007-06-11   ########   34872      Type III   6L07-20 42740Q100, 46181Q100, 42722Q100
2007-06-11   ########   35431      Type II    N/A        N/A
2007-06-11   ########   35447      Type III             43004HW00, 46063HW00, 43006HW00, 46061HW00
                                              7D79-20, 7D79-30
2007-06-25   ########   32361      Type II               240, 256, 271, 317, 430
                                              ALLURA XPER FD10 CL
2007-06-25   ########   34013      Type II               06cm6000100 to/à 06cm6111020, 06cml111004 to/à 0
                                              PD1000A-CAN-M6, PD1000A-CAN-ML6
2007-06-25   ########   34534      Type II               A)
                                              A) N/AB) N/A N/AB) N/A
2007-06-25   ########   35291      Type II    CT067B     471678
2007-06-25   ########   35427      Type I                N/A
                                              4095705, 4095905
2007-06-25   ######## 34576        Type II    N/A        Software version 1.1 and 1.2 / Version de logiciel 1.1 et
2007-06-25   ######## 35442        Type II               A) N/AB)
                                              A) N/AB) N/AC) N/A N/AC) N/A
2007-06-25   ######## 35682        Type II    N/A        754801F
2007-06-25   ######## 35691        Type II    N/A        CXP Version 2.1 and/et 2.2
2007-06-25   ######## 35741        Type III   D7TPSL252RTN/A
2007-06-25   ########   34172      Type II    581745     N/A
2007-06-25   ########   35448      Type II               All lots / Tous les lots.
                                              7L01-01, 7L02-01, 7L06-01, 7L07-01
2007-06-25   ########   35636      Type II               N/A
                                              09-0210, 09-0212, 09-0214, 09-0215, 09-0217, 09-0221, 09-0222
2007-06-25   ########   35676      Type III   4J86-90    400923
2007-06-25   ########   35787      Type III   2995       18943
2007-06-25   ########   34682      Type III              to this recall this recall posted on posted on / Corr
                                              Correction Correction to previously previously 2007-06-11.2007-0
2007-03-19   ########      34219   Type III              40909JN00, 43949JN00, 40910JN00, 43957JN00, 40911
                                              7K63-20, 7K63-25, 7K63-30
2007-03-19   ########      34281   Type III              A) N/AB) N/A
                                              A) 08717741B) 08717733
2007-03-19   ########      34292   Type III   N/A        N/A
2007-03-19   ########      34385   Type II               A) R06F05158, R06F22013B) R06I10067
                                              A) 2C8857B) 2C7557
2007-03-19   ########      31356   Type I     H199       301286, 301295
2006-10-02   ########      32273   Type II    N/A        all lot numbers in 2.1.0 - 4.3.0 / Tous les numéros de lo
2006-10-02   ########      32274   Type II               > 100
                                              H14, H27, H29 lot numbers, contact manufacturer. / > à 100 num
2006-10-02   ########      32285   Type II               A)
                                              A) N/AB) N/A system 6.5 & more/et plus, eclipse 7.1.35 & more/et
2006-10-02   ########      32294   Type II               N/A
                                              P3207A01, P3207A02
2006-10-02   ########      31922   Type III   0002332 21210
2006-10-02   ########      31759   Type II               > 10 lot numbers, contact manufacturer. / 600C/D, 600
                                              2100C, 2100C/D, 2100SC, 21EX, 2300C/D, 23EX, 600C,> à 10 numé
2006-10-02   ########      31963   Type III              A) N/AB) N/AC) N/AD) N/AE) N/A
                                              A) 900000-104, 900000-304, 920000-104B) 940000-104, 940000-3
2006-10-02   ########      32100   Type II    S1730      QR-02
2006-10-02   ########      32205   Type II    03253678122N/A
2006-10-02   ########      32301   Type III   4126       22026/01, 14036/01, 14036/02, 24046/02, 12066/01, 1
2006-10-02   ########      32304   Type III   9226-00 Serial number starting with 138- / Numéros de séries co
2006-10-02   ########      32296   Type III   SE-252     28423
2006-10-02   ########      32312   Type III              5
                                              0506201404 76108
2006-10-02   ########      32195   Type III   28637      444881, 445348
2006-10-02   ########      32333   Type II                2M8153R, Numbers. / Tous les DNM 8153R, DNM8153
                                              A) 2M8153,A) All serial 2M8163, 2M8163R, numéros de séries.B) A
2006-10-02   ########      32339   Type III   N750-BMK-FSN/A
2006-10-02   ########   32178   Type II                PW-D06-00001 to/à PW-DO6-00400
                                           PW1002, PW1100
2006-10-02   ########   32180   Type III               D1401
                                           PW1002, PW1100 to/à D1700
2006-10-02   ########   32287   Type III   01-3714 168720
2006-10-02   ########   32344   Type III   240952      16562410, 16629910
2006-10-02   ########   32351   Type III               A) All lot numbers. / Tous N750-XT-FSD) lot.B) 610000
                                           A) N750-BMK-FSB) N750-BMKLT-FS C)les numéros de N750-DISXT-FS
2006-10-16   ########   32353   Type II    340498      45602
2006-10-16   ########   32288   Type II    915-2335 753200
2006-10-16   ########   32120   Type II                All serial numbers. / Tous les numéros de série.
                                           001-800040, 002-800130, 003-800402, 800119, 800326, 800390
2006-10-16   ########   32379   Type II    Treatment H462016-H462087, H510394-H512365
2006-10-16   ########   32331   Type III               A) N/AB) N/AC) N/A
                                           A) CSISB) CSITC) CSILTC
2006-10-16   ########   32362   Type III   E2DR31 PNL615066S
2006-10-16   ########   32383   Type III   4D019UL W3, W4
2006-10-16   ########   32386   Type III               > 10 lot IH820-3MDLX, IHSC900DLX, SC900-80WDLX-QS
                                           IH820-03MDLX-QS, numbers, contact manufacturer. / > à 10 numé
2006-10-16   ########   32245   Type III   7428        NFD100006H-NFD100325H, NFD620017S-NFD625737S
2006-10-16   ########   32278   Type II                All P/N 71434302, P/N 71434304, P/N 71434306
                                           P/N 71434301,lots prior to 06MM*****sequence, including those
2006-10-16   ########   32309   Type II                 427002100
                                           427002000,Lot numbers ending with 076 and prior to 133086-1360
2006-10-16   ########   32359   Type II                A
                                           B01-4784-01ll lot numbers. / Tous les numéros de lot.
2006-10-16   ########   32388   Type II    70402       > 10 lot numbers, contact manufacturer. / > à 10 numé
2006-10-16   ########   31344   Type I                 N/A
                                           700.08310 (24 Pouces/24 Inches)700.08320 (36 Pouces/36 Inches)
2006-10-16   ########   30373   Type II    N/A         All lot numbers sold prior to April 19, 2006. / Tous les n
2006-10-16   ########   32374   Type II    58821       50417
2006-10-16   ########   32393   Type II                0
                                           60-8005-SYS 6FGP039, 06FGP044
2006-10-16   ########   32375   Type II    1007        N/A
2006-10-16   ########   32392   Type III   1532316 005606800237, 005606802702, 005606802703, 00560
2006-10-16   ########   31971   Type III               All lot numbers. / Tous les numéros de lot.
                                           7D70-20, 7D70-30
2006-10-16   ########   32365   Type III   09C08-10 29506M100
2006-10-16   ########   32417   Type III   67018.5 1008187
2006-10-16   ########   32310   Type II    N/A         239FR
2006-10-16   ########   32427   Type III   N/A         05135, 5-05135
2006-10-30   ########   32341   Type II                Serial 20010-2805-000
                                           20010-0000-081, #'s up to # 631R. / Numéros de série allant jusqu'
2006-10-30   ########   32428   Type II    N/A         2631383
2006-10-30   ########   32430   Type I                 700.11505
                                           700.11500, N/A
2006-10-30   ########   32462   Type III   03E48-05 N/A
2006-10-30   ########   32020   Type II                A) All lot 544240C) Tous les
                                           A) 543965B) 544230,numbers. / 544250 numéros de lot.B) All lot n
2006-10-30   ########   32237   Type III   N/A         N/A
2006-10-30   ########   32469   Type II                A)
                                           A) N/AB) N/A 07722-5, 07722-8, 07722G, 07725B) 30751W, 30757
2006-10-30   ########   32484   Type II    A-7059      2095
2006-10-30   ########   32492   Type III   N/A         All lot numbers. / Tous les numéros de lot.
2006-10-30   ########   32286   Type II                All lots prior to 06HM****sequence. /
                                           71434301, 71434302, 71434304, 71434306
2006-10-30   ########   32449   Type II                A) 11888199B) 1189026C) 1189023D) 1189038E) 1189
                                           A) 5-16037B) 5-22315C) 5-22210D) 5-22006E) 5-24006
2006-10-30   ########   32512   Type II    N/A         F22741, F22743, F22744
2006-10-30   ########   32311   Type II    N/A         Version 7.4
2006-10-30   ########   32313   Type III   N/A         N/A
2006-10-30   ########   32362   Type III   E2DR31 PNL615066S, PNL615043S, PNL615028S
2006-11-13   ########   32280   Type II    71512903 00709723A, 02CM04983A, 06DM11394, 06DM11396, 0
2006-11-13   ########   32498   Type II                4310,
                                           Version 1.2/4C 4336
2006-11-13   ########   32378   Type III   030002-03 All serial numbers. / Tous les numéros de série.
2006-11-13   ########   31054   Type III              A)
                                           A) N/AB) N/A > 10 lot numbers, contact manufacturer. / > à 10 num
2006-11-13   ########   32529   Type I                A) Batches N/AE) N/A
                                           A) N/AB) N/AC) N/AD) manufactured since October 2003. / Lots fab
2006-11-13   ########   32528   Type II    ES885      Version NX 1.0.2402 , Version NX 1.0.2405
2006-11-13   ########   32381   Type III              A) N/AB) N/AC)
                                           A) N/AB) N/AC) N/AD) N/A N/AD) N/A
2006-11-13   ########   32522   Type III   280033     65, 70, 96, 73, 29, 32, 30, 31, 78, 12, 79, 93, 27, 26, 10,
2006-11-13   ########   32531   Type II    0002332 35411
2006-11-13   ########   32598   Type II    N/A        N/A
2006-11-13   ########   32599   Type III              5948 3235-XXXX
                                           1668409, 8297749
2006-11-13   ########   32603   Type II    N/A        N/A
2006-11-13   ########   32533   Type II               A) N/AB) N/AC) N/A
                                           A) 60-6040-002, 60-6040-003, 60-6040-004, 60-6040-005, 60-6040
2006-11-13   ########   32593   Type II               N/A
                                           2836, 2836-1968, 3643, 3643-1968, 4250, 4250-1968, 4860, 4860-
2006-11-13   ########   32610   Type II               A)
                                           A) N/AB) N/A N/AB) N/A
2006-11-13   ########   32616   Type II               A) N/AB) 14 330
                                           A) 100 14 455B) 100 N/A
2006-11-13   ########   32617   Type II    N/A        N/A
2006-11-13   ########   32618   Type III   N/A        N/A
2006-11-13   ########   32631   Type III   08H00-01 All lot numbers. / Tous les numéros de lot.
2006-11-13   ########   32451   Type II    N/A        N/A
2006-11-13   ########   32503   Type III   9153000 050906, 061306
2006-11-13   ########   32523   Type II    N/A        N/A
2006-11-13   ########   32640   Type III   SSA-700A N/A
2006-11-13   ########   32627   Type II    ITHA52     560988
2006-11-13   ########   32639   Type II    N/A        N/A
2006-11-13   ########   32669   Type III   9800-3275 Versions 1.55, 1.91, 2.01
2006-11-13   ########   32670   Type III              A)
                                           A) N/AB) N/A N/AB) N/A
2006-11-13   ########   32674   Type II               A)
                                           A) N/AB) N/A N/AB) N/A
2006-11-13   ########   32562   Type II               All 03116247001
                                           03116239001, lot numbers. / Tous les numéros de lot.
2006-11-27   ########   30937   Type II               20060103/MAGIC 1.2 STD
                                           MAGIC 1.2FM, MAGIC MP, MAGICFM, 20060103/MAGICSTD, 2006
2006-11-27   ########   32669   Type III              A) B1018-527B) Version 1.55,
                                           A) B1018-524,Version 1.55B)9800-3275 1.91, 2.01
2006-11-27   ########   32698   Type II    N/A        N/A
2006-11-27   ########   32699   Type II    N/A        5-22315/Lot number/Numéro de lot 1189026.
2006-11-27   ########   31833   Type III              A) N/AB) N/AC) 07152460D) 5904086E) 5902767, 5902
                                           A) 07152478B) 05902775C)N/AD) N/AE) N/AF) N/AG) N/AH) N/AI )
2006-11-27   ########   32628   Type II               N/A
                                           DKY056, DKY057, DKY058, DKY059
2006-11-27   ########   32428   Type II    010-665 2631383
2006-11-27   ########   31971   Type III   N/A        All lot numbers. / Tous les numéros de lot.
2006-11-27   ########   32504   Type III               01-9181, 01-9182B)
                                           A) 01-9180,A) N/AB) N/AC) N/A 24-2050, 24-2115C) 01-7149, 01-7
2006-11-27   ########   32733   Type II    912800     N/A
2006-11-27   ########   32740   Type II               A) N/AB) N/AC)
                                           A) N/AB) N/AC) N/AD) N/A N/AD) N/A
2006-11-27   ########   32765   Type III   08648375 300477
2006-11-27   ########   32766   Type II    7387074 20570
2006-11-27   ########   32767   Type II    08355088 1019
2006-11-27   ########   32768   Type II    11 58 059 1065, 1274
2006-11-27   ########   32769   Type II    N/A        518729, 520617, 612764, 613481, 614541, 616797
2006-11-27   ########   32770   Type II    N/A        N/A
2006-11-27   ########   32774   Type II    8H00-01 All lot numbers. / Tous les numéros de lot.
2006-11-27   ########   32775   Type III   N/A        08046-A, 08046-C
2006-11-27   ########   32779   Type II               1009446, 1035977, 1043174, 1046075, 1048466, 10609
                                           D-60HL, DI-60HL
2006-11-27   ########   32784   Type III              A) 93111-01, 99120-01
                                           A) 07H77-01B)All lot numbers. / Tous les numéros de lot.B) All lot n
2006-11-27   ########   32789   Type III   OPAX03 064238, 064614, 064781
2006-11-27   ########   32791   Type III   825-000 24448
2006-12-11   ########   32490   Type III   N/A        15
2006-12-11   ########   32712   Type II    4220-4K 5-09076
2006-12-11   ########   32812   Type III   6C24-01 33363Q100
2006-12-11   ########   32208   Type II               TCBN001, 400-15CN
                                           400-05CN, 400-10CN, TCBN002, TCKM002, TCCN003, TCFM001, TC
2006-12-11   ########   31601   Type II    TSX-101A a2622017, a3512031, a3572185, a3612273, b4622183,
2006-12-11   ########   32638   Type III              188391, 7501, 76101
                                           70510, 7101, 74201,188637, 188102, 188636, 188702, 188392, 18
2006-12-11   ########   32814   Type II    N/A        7062, 7017
2006-12-11   ########   31695   Type III              All lot numbers. / Tous les numéros de lot.
                                           Auto-Phoroptor, Auto-Phoroptor Software, RS232C Comm. Interfa
2006-12-11   ########   32773   Type II    844001     N/A
2006-12-11   ########   32834   Type III   N/A        051240284 - 060839217
2006-12-11   ########   32787   Type II               A) N/AB) N/AC) N/A
                                           A) 0031100B) 0031030, 0031050, 0031070, 0033080, 0033100, 00
2006-12-11   ########   32842   Type III   1E08-20 39074HW00, 41008HW00, 42063HW00
2006-12-11   ########   32851   Type II    99120-01 3099, 3100, 3098
2006-12-11   ########   32735   Type II               N/A
                                           1005792, 1007861
2006-12-11   ########   32771   Type II    N/A        N/A
2006-12-11   ########   32864   Type II                80920, 971083E, 971084E
                                           971081E, 971082E, 80974, 81105, 82025, 82630, 82631, 83060, 83
2006-12-11   ########   32606   Type II    N/A        N/A
2006-12-11   ########   32826   Type II    N/A        Identifier S12-4
2006-12-11   ########   32827   Type II    N/A        882410
2006-12-11   ########   32923   Type II    XT125      U706, U707, U708, U709, U710, U711, U712
2006-12-11   ########   32927   Type II               CXL08071, CXL08072, CXL08073
                                           B5980-1, B5980-2, B5980-3
2006-12-11   ########   32593   Type II               N/A
                                           2836, 2836-1968, 3643, 3643-1968, 4250, 4250-1968, 4860, 4860-
2006-12-11   ########   32817   Type III              Serial
numbers
starting
with
the
following
two-letter
co
                                           020-720, 020-721
2006-12-11   ########   32909   Type II    N/A        3520, 3582, 3550, 3519
2006-12-11   ########   32662   Type II               082306, 091306, 091206, 091506, 092606, 091806, 08
                                           MIS300, MIS401
2006-12-11   ########   32928   Type II    N/A        Serial # M3186023572, Lot # 125900
2006-12-11   ########   32955   Type III              A)
                                           A) N/AB) N/A Serial # M02250477, Lot # 0600141B) Serial # M02PT
2006-12-11   ########   30550   Type II                DFP-8000D/FPD
                                           DFP-8000D,a4562104, b5522164, b3512023, b4562192, b4572196
2006-12-11   ########   32953   Type II    220-0201 20061555, 20061557, 20061598, 20061600, 20061537
2006-12-11   ########   32965   Type III              070643745, 070645595, 070643744, 080649145, 0706
                                           491-4460, 491-4461, 491-5460, 491-5461
2006-12-25   ########   32855   Type III              All lot 26-0125
                                           26-0122, 26-0123,numbers with last 4 digits < 1595. / Tous les num
2006-12-25   ########   32944   Type II    340498     51184, 57821
2006-12-25   ########   32376   Type II               A) Various lot numbers. /
                                           A) MRT 6001, MRT 6011B) XRT 0401 Numéros de lot divers.B) Vario
2006-12-25   ########   32786   Type II               A) N/AB) N/A
                                           A) MRT 6001, MRT 6011B) XRT 10601
2006-12-25   ########   33003   Type II               A) All serial
                                           A) 2M8063B) 2M8064 numbers. / Tous les numéros de séries.B) Al
2006-12-25   ########   33014   Type II    00939001 N/A
2006-12-25   ########   33015   Type II    HL 30      N/A
2006-12-25   ########   33048   Type I     N/A        6090652, 6090751
2006-12-25   ########   33065   Type II               A) N/AB) N/A
                                           A) 4504200B) 5857912
2006-12-25   ########   33053   Type II               0000000E9-0027, 0000000E9-0148, 0000E2-2026-MH
                                           00-870683-01
2006-12-25   ########   33044   Type II               31160, 31170, 31180, 31190, 31200, 31530, 31540
                                           645, 645X, 646, 647, 648, 649, 649X
2006-12-25   ########   32920   Type II               A) N/AB) N/A
                                           A) 20753491122B) 20757497122
2006-12-25   ########   33076   Type II               A)
                                           A) N/AB) N/A N/AB) N/A
2006-12-25   ########   33124   Type II               Catalogue # 6C25-22, 6C25-27 Lot # 33198M200,41861
                                           6C25-22, 6C25-27
2006-12-25   ########   33128   Type III   N/A        N/A
2006-12-25   ########   33180   Type III   N/A         N/A
2006-12-25   ########   33214   Type II    08355088 N/A
2006-09-18   ########   32162   Type II    T266H, T266WN/A
2006-09-18   ########   32163   Type II                A) All lot numbers. / Tous les numéros de lots.B) 740E/2
                                           A) 740C/125, 740C/225B) 745E/125, 745E/225C) 740E/125, All lot
2006-09-18   ########   32216   Type II                A)
                                           A) N/AB) N/A N/AB) N/A
2006-09-18   ########   32198   Type II    C2HS        N/A
2006-09-18   ########   32241   Type II                A) All lot JC5381N, JC5386N, JC5390N, JC5537N, JC5546
                                           A) JC0430, JC5380N, numbers. / Tous les numéros de lots.B) All lot
2006-09-18   ########   32257   Type II                N/A
                                           775-855P , 775-860
2006-09-18   ########   32134   Type II    IMPAX MA3000N/A
2006-09-18   ########   32269   Type III   31966       448798, 449556, 451706
2006-09-18   ########   32268   Type II    N/A         000000086-1508, 000000086-1665, 000000086-1401,
2006-09-18   ########   32272   Type I                 > 10
                                           1011-9000-000 lot numbers, contact manufacturer. / > à 10 numé
2006-09-18   ########   31413   Type II    N/A         436332BU1
2006-05-15   ########   31191   Type I                 A) All serial numbers.
                                           A) 09-1694-0000B) 09-1527-0000/ Tous les numéros de séries.B) Al
2006-05-15   ########   31179   Type II                 010-746B) 010-776
                                           A) 010-658,A) N/AB) Serial# L3152 Rx xxxxx to/à L5348 Rx xxxxx
2006-05-15   ########   31208   Type III                5M2730U, 5M5725B) RENLSFTC) RENLSFTD) RENLSFTE
                                           A) 5M2730,A) V.2.0, V.1.1, Renal Software Suite 3.1B) V.2.0, V.1.1,
2006-05-15   ########   31103   Type II                1-1028: 0310061 TO 05021411-1008: 0310201 TO 0502
                                           1-1008, 1-1028
2006-05-15   ########   31258   Type III               7
                                           GTR08020252105015, 072505001
2006-05-15   ########   31271   Type III   N//A        N/A
2006-05-15   ########   31199   Type II                5953, 5947, 5961, 5997,
                                           TK1100, TK1900, TK2000, TK2100 15021, 15028, 15078, 15081, 1
2006-05-01   ########   31115   Type I                 A) > 10 lot numbers, contact INF 04540883001, 10 num
                                           A) INF 04540824001, INF 04540867001, manufacturer. / > àINF 045
2006-05-01   ########   31189   Type II                 2M8163, DNM8153B) Tous les numéros de séries.B)
                                           A) 2M8153,A) All serial numbers. / 2M8151, 2M8161, DNM8151 Al
2006-05-01   ########   31102   Type III               A) 745815F, 745816F, 745817FB) 716204F, 716205F, 71
                                           A) 6604625B) 6603511C) 6602389D) 6602385E) 6602434
2006-05-01   ########   31206   Type III               A) N/AB) N/AC) N/AD)
                                           A) N/AB) N/AC) N/AD) N/AE) N/A N/AE) N/A
2006-05-01   ########   31051   Type II                A) Software version 4.5B) Software version 4.5C) Softwa
                                           A) A23724B) A23724C) A20463D) A27331
2006-05-01   ########   30944   Type II    N/A         N/A
2006-05-01   ########   31192   Type II    408304      1172053
2006-05-01   ########   31090   Type II    ESP         > 100 lot numbers, contact manufacturer. / > à 100 num
2006-05-01   ########   31003   Type II                All lot numbers. / Tous les numéros de lots.
                                           Shade A2, Shade A3
2006-05-01   ########   31202   Type II    N/A         All powered handpieces, bur guards and associated atta
2006-05-01   ########   31160   Type III   N/A         12624, 12299
2006-05-01   ########   31178   Type II    474824      M507219, M511327
2006-04-17   ########   31069   Type II                A) 236023002, 235276002, CBHCG-DD) 235311002, 23
                                           A) CCTNIB) CPBNP, CPBNP-DC) CBHCG, 235290002, CKMB, CKMB-D
2006-04-17   ########   30896   Type II                A) N/AB) N/AC) N/AD) N/AE) N/AF) N/AG) N/A
                                           A) 0605550, 0605560, 0605840, 0605850, 0607301, 0607302, 060
2006-04-17   ########   31086   Type III   35 45 584 N/A
2006-04-17   ########   30854   Type II    N/A         All lot numbers. / Tous les numéros de lots.
2006-04-17   ########   31096   Type II    N/A         > 100 lot numbers, contact manufacturer. / > à 100 num
2006-04-17   ########   30986   Type II    N/A         Various lot numbers. / Plusieurs numéros de lots.
2006-04-17   ########   28720   Type II                2511587, 3094043, 3040106, 110047, 110163
                                           9033G0711, 9033G0712
2006-04-17   ########   31026   Type II    N/A         40152, 40089, 40215, 40091, 40218, 40232, 20120, 401
2006-04-17   ########   31042   Type II                1001-22000
                                           STS1000-L3PDP, SYS1000-L3DPA, SYS1000-L3DPHA, SYS1000-L3P, S
2006-04-17   ########   29467   Type II    Z9000       8161620508, 8161680508, 8161690508, 8161700508
2006-04-03   ########   30318   Type II                A) N/AB) N/AC) N/A
                                           A) 3070039B) 3070013C) 3070021, 3074486
2006-04-03   ########   30513   Type II                A) N/AB) N/AC) N/A
                                           A) 3070039B) 3070013C) 3070021, 3074486
2006-04-03   ########   30512   Type I                 A) N/AB) N/A
                                           A) N/AB) RT110, RT111, RT210, RT211
2006-04-03   ########   30984   Type II                A) >100 lot FMA604CB) M1-280-16FM, M1-320-P, M1-
                                           A) FMA104C, FMA601, numbers, contact manufacturer. / > à 100 n
2006-04-03   ########   30613   Type II                A)
                                           A) N/AB) N/A 4.6 TO 4.7.1B) 4.6 TO 4.7.1
2006-04-03   ########   30913   Type II               N/A
                                           A) 7393114B) 8377520
2006-04-03   ########   30894   Type III              All 12030586001
                                           12030578001, lot numbers. / Tous les numéros de lots.
2006-04-03   ########   30949   Type II               All serial
                                           1M8550, 1M8550R numbers. / Tous les numéros de séries.
2006-04-03   ########   30486   Type III              >100 lot / Plusieurs numéros
                                           Numerous numbers.numbers, contact manufacturer. / > à 100 num
2006-04-03   ########   30932   Type III   CRS MasterN/A
2006-04-03   ########   30953   Type III              Software Version 2.0 ,
                                           629636, 629637, 722645, 723113 Software Version 2.1
2006-04-03   ########   30933   Type III   DF92A      CP6224
2006-04-03   ########   30983   Type III   RF420      CG7003, DE6347
2006-04-03   ########   31004   Type III   N/A        N/A
2006-04-03   ########   30596   Type II               N/A
                                           107959, 107965, 107991
2006-04-03   ########   30975   Type I                MC6-1014,
                                           659-0002, 659-0020 MC6-1077, MC6-1081, MC6-1101, MC6-112
2006-04-03   ########   30650   Type II    N/A        4310, 4210, 4366
2006-04-03   ########   30960   Type II    N/A        3005384-000 Through -002
2006-04-03   ########   30917   Type III   N/A        >10 lot numbers, contact manufacturer. / > à 10 numér
2006-04-03   ########   30378   Type II    AT         2767, 2762
2006-04-03   ########   30895   Type III              427936, 428569, 31955, 429106, 427793, 428572, 42
                                           31513, 31514, 31736, 31954,428290, 32611, 32612, 32684.
2006-04-03   ########   30941   Type III   N/A        1.22E+08
2006-04-03   ########   30906   Type III   N/A        33376Q100
2006-05-29   ########   30883   Type III   71420102 05DM10763
2006-05-29   ########   31232   Type II               A) H2057 to/à H2182B)
                                           A) 24350, 24355B) 24365C) 24370 H2057 to/à H2182C) H2057 to/
2006-05-29   ########   31233   Type I     GM11019110 GM00253, GM0E140, GM0E143, GM3185969501000, G
2006-05-29   ########   31284   Type III   5030, 5030SH11-05-138, H11-05-139, H11-05-140, H11-05-040, H11
2006-05-29   ########   31237   Type II               All lot numbers. / Tous les numéros de
                                           7156-5611 Impactor, 7156-5619 Torque Wrench lots.
2006-05-29   ########   31248   Type I     050-87207 5SR125, 6AR044, 6AR267
2006-05-29   ########   31261   Type III              A)
                                           A) N/AB) N/A M0068504000, M0068504001B) M0068505000, M0
2006-05-29   ########   31307   Type II               A) 2005052002, 2005060703, 2005062001, 200506200
                                           A) 0500-120-000B) 0501-100-000, 0501-120-000
2006-05-29   ########   31235   Type II    C9054      > 100 lot numbers, contact manufacturer. / > à 100 num
2006-05-29   ########   31309   Type II               A)
                                           A) N/AB) N/A H749389420, C4020B) C2018
2006-05-29   ########   31316   Type II               All software versions. / Toutes les versions du logiciel.
                                           178832, 178833, 178834
2006-05-29   ########   31320   Type II               A)
                                           A) N/AB) N/A N/AB) N/A
2006-05-29   ########   31317   Type II    33200      All lot numbers. / Tous les numéros de lots.
2006-05-29   ########   31330   Type II             A) N/AB) 16347, 17343, 49928, 63814, C) LA63DRC, L
                                           A) SB63DRCB) ZM5SR40, ZM6EBU40, ZM6SR40,64598, 129423,
2006-05-29   ########   31355   Type III   10-9456-01All lot numbers. / Tous les numéros de lots.
2006-05-29   ########   31352   Type II    J740D      SB2430
2006-05-29   ########   31356   Type I     H199       301286, 301295
2006-05-29   ########   31128   Type I                All
                                           M6275080/5 lots after 05.13.05.01. / Tous les lots après 05.13.05
2006-05-29   ########   31232   Type II               H2057 to/à H2182.
                                           24350, 24355
2006-05-29   ########   31223   Type II    N/A        Various lot numbers. / Plusieurs numéros de lots.
2006-05-29   ########   31370   Type III              A) 5004469B) 4174884C) 4092221, 3254219D) 3352124
                                           A) 228141B) 228181C) 229471D) 229731E) 229511F) 228191G) 22
2006-05-29   ########   31395   Type III   335775     28357
2006-05-29   ########   31371   Type III              N
                                           B03-4847-55 /A
2006-05-29   ########   31412   Type II               K971998, A970782
                                           067-A011-02, 067-A012-01
2006-05-29   ########   31413   Type II    N/A        436332BU1
2006-05-29   ########   31222   Type II    N/A        All lot numbers. / Tous les numéros de lots.
2006-06-12   ########   30849   Type II    N/A        Software Version 3.1.0
2006-06-12   ########   30991   Type II                58810
                                           A) 58816 B)A) 50913B) B50822
2006-06-12   ########   31104   Type II    58842      50608C, 50609, 60165
2006-06-12   ########   31334   Type II    N/A        REPJ1096
2006-06-12   ########   24072   Type II    8820       Serial Number Beginning with NCP. / Numéro de série c
2006-06-12   ########   30990   Type II    975, 975X 78510
2006-06-12   ########   31236   Type II    64999      N/A
2006-06-12   ########   31318   Type II    N/A        ILAB120CART, ILAB120CARTR, ILAB120CARTD, ILAB220
2006-06-12   ########   31476   Type II               A) N5L380, N5M159, N6B02, N6B45, N5M255B) N5M40
                                           A) 120039, 120049B) 120021, 120025, 120045, 120066
2006-06-12   ########   31478   Type II    2L3107     All serial numbers. / Tous les numéros de séries.
2006-06-12   ########   30851   Type III   ERYE4      N/A
2006-06-12   ########   31354   Type II    CTRF117 C5C176C
2006-06-12   ########   31461   Type II               A) J5121206, J6013008, J6031601, J6031008B) J512090
                                           A) K16A, K16BB) K17A, K17B
2006-05-12   ########   31179   Type II                010-746B) 010-776
                                           A) 010-658,UPDATED RECALL # 31179 PREVIOUSLY POSTED ON 200
2006-06-26   ########   31509   Type II               A) 3200-1715, 3250-1780B) 291538, 294210, 296276,
                                           A) 3114-1741, 282942, 284031, 288967, 3200-1711
2006-06-26   ########   31541   Type II    N/A        3511, 3513, 3515, 3517, 3519, 3521
2006-06-26   ########   31151   Type II    N/A        800.604.02S, 800.604.04S, 805.604.02S, 805.604.04S, 8
2006-06-26   ########   31553   Type III   01H73-01 All lot numbers. / Tous les numéros de lots.
2006-06-26   ########   31558   Type II    N/A        iSite Radiology V3.3
2006-06-26   ########   31559   Type III   9669-11 33482Q100
2006-06-26   ########   31563   Type II               A)
                                           A) N/AB) N/A MRC 1091, MRC 1101B) MRC 1151
2006-06-26   ########   31565   Type II    N/A        453567088051
2006-06-26   ########   31101   Type III              33079M200, 33079M201
                                           6C09-22, 6C09-27
2006-06-26   ########   31531   Type III   3142       26322, 26797G, 26791, 26355, 26529, 26454, 25743
2006-06-26   ########   31577   Type II    N/A        N/A
2006-06-26   ########   31583   Type III              A) N/AB) N/AC) N/AD) N/AE) N/A F) N/A
                                           A) 5904656B) 5904649C) 7412807D) 5904441 E) 59 04 433F) 5904
2006-06-26   ########   31034   Type II    N/A        >10 Lot numbers, contact manufacturer. / > 10 numéro
2006-06-26   ########   31589   Type II               A)
                                           A) N/AB) N/A 04051142 - 04112922B) 04317FE2 - 06123FE2
2006-06-26   ########   31532   Type II    N/A        N/A
2006-06-26   ########   31598   Type II               A)
                                           A) N/AB) N/A 796076 to/à 796315B) 11637 to/à 12321
2006-06-26   ########   31620   Type II    06F01-01 U06024B
2006-06-26   ########   31529   Type II    019-435600 019-435600
2006-06-26   ########   31630   Type II    BP48R      40706
2006-06-26   ########   31238   Type II               10751A,
                                           EG209V, EG365V 11059A, 11058A, 10806A
2006-03-20   ########   30822   Type II    5.61E+08 418483
2006-03-20   ########   30820   Type III              A) N/AB) N/AC) N/A
                                           A) 7412807B) 7555365C) 7008605
2006-03-20   ########   30811   Type III                B) 5904649C) N/AD) N/AE) N/AF) N/AG) N/A
                                           A) 5904656A) N/AB) N/AC)7412807D) 7008605E) 5904441F) 59 04
2006-03-20   ########   30810   Type III              A) N/AB) N/A
                                           A) 88 74 427 B) 83 77 520
2006-03-20   ########   30778   Type II    N/A        N/A
2006-03-20   ########   30791   Type III              All serial
                                           08C89-01, 3M74-01 numbers. / Tous les numéros de séries.
2006-03-20   ########   30838   Type II               All serial
                                           1M8560, 1M8560R numbers. / Tous les numéros de séries.
2006-03-20   ########   30231   Type III   N/A        > 100 lot numbers, contact manufacturer. / > à 100 num
2006-03-20   ########   30871   Type II               8036960
                                           M00202175930P0
2006-03-20   ########   30808   Type III   7A28-40 N/A
2006-03-20   ########   29026   Type I     N/A        Numerous lot numbers. / Plusieurs numéros de lots.
2006-03-20   ########   30789   Type III              All lots made prior to Nov 05. / Tous les 83-7712-035-0
                                           00-7712-035-01, 00-7712-035-02, 83-7712-035-01, lots fabriqués a
2006-03-20   ########   30709   Type II    N/A        N/A
2006-03-20   ########   29920   Type II    N/A        >10 lot numbers, contact manufacturer. / > à 10 numér
2006-03-20   ########   30800   Type II               All serial numbers. / Tous les numéros de séries.
                                           STS1000-L3PDP, SYS1000-L3DPA, SYS1000-L3DPHA, SYS1000-L3P, S
2006-03-20   ########   30872   Type II    441470     M411138
2006-03-20   ########   30861   Type II               H1105A,
                                           17-LHFK-2, CM-5003B0805B, E0605A, M976030
2006-03-20   ########   30413   Type II               Various lot numbers. / Numéros POSTED ON
                                           UPDATED RECALL # 30413 PREVIOUSLY de lot variés. 2006-02
2006-03-06   ########   30172   Type II               A) ARENASPP-D, ARENASPP-DH. B) ARENASPX-BDH, Al
                                           A) ARENA SPP,All serial numbers. / Tous les numéros de séries.B) AR
2006-03-06   ########   30582   Type II               A)
                                           A) N/AB) N/A N5L235K and Lower. / N5L235K et moins.B) N5L247K
2006-03-06   ########   30702   Type II               A) 1019, 1060B) N/A
                                           A) 8646460B) 8620192
2006-03-06   ########   29711   Type I                A) 2M9832, 2M9832R, 60600040IR
                                           A) D2M9832B)All serial numbers. / Tous les numéros de séries.B) Al
2006-03-06   ########   30238   Type III   N/A        79260070
2006-03-06   ########   30748   Type III   2K41-20 95567G005
2006-03-06   ########   30754   Type III   N/A        All lot numbers. / Tous les numéros de lots.
2006-03-06   ########   30747   Type III   7A61-12 25525Q100
2006-03-06   ########   30597   Type II    N/A        N/A
2006-03-06   ########   30010   Type III              4335932, 4335935, 4335938, 4335940, 4335944, 5024
                                           260651, 260656.
2006-03-06   ########   30021   Type II    440911     5075281
2006-03-06   ########   30600   Type II    N/A        Numerous lot numbers. / Plusieurs numéros de lots.
2006-03-06   ########   29150   Type II    944-069 9946
2006-03-06   ########   30662   Type III   N/A        30000011 to/à 30000249
2006-03-06   ########   28760   Type I                5400-050-000, 0517400143, 0519200783, 051740005
                                           0517400023, 0517400113,5400-050-000a, 051740023,951740005
2006-03-06   ########   30384   Type III              N/A
                                           6605500, 6706366
2006-03-06   ########   30217   Type III              N/A
                                           PRX-9495, PRX-9496
2006-03-06   ########   30598   Type II    N/A        Numerous lot numbers. / Plusieurs numéros de lots.
2006-03-06   ########   30708   Type II    484, 485 N/A
2006-03-06   ########   28775   Type II               0
                                           295-001-000428702183 to/à 0518008193
2006-03-06   ########   29670   Type II    N/A        N/A
2006-03-06   ########   30649   Type II    3011790 N/A
2006-03-06   ########   30676   Type II               3200731-ALL / Tous3202177-000 to/à -002
                                           80403-000002, 80403-000008, 80403-000010, 80403-000022, 804
2006-03-06   ########   30599   Type III   N/A        91520, 91521, 91522, 91523
2006-03-06   ########   30648   Type III   1E65-02 19906m200, 20879m100, 26674m100
2006-03-06   ########   30614   Type III   936400     N/A
2006-03-06   ########   28098   Type II    N/A        9631to 9657 Inclusive. / 9631à 9657 Inclusivement.
2006-03-06   ########   30767   Type III   0070-010 110073, 109288.
2006-03-06   ########   30428   Type II               5905K7, 5905K8, 5905K9, 5905K10, 5906K1, 5906K2, 5
                                           K3-9692/9793
2006-03-06   ########   30602   Type II    N/A        Numerous lot numbers. / Plusieurs numéros de lots.
2006-03-06   ########   28762   Type I                 18976070S, K808190
                                           18976065S,K400117 to/à18976075S, 18976080S, 18976085S, 1897
2006-02-20   ########   29974   Type II               A)
                                           A) N/AB) N/A N/AB) N/A
2006-02-20   ########   30344   Type II               A)
                                           A) N/AB) N/A > 1000.Contact Manufacturer. / Communiquez avec
2006-02-20   ########   30322   Type II               A) 25043, 25066, 25089, 25097, 25137, 25173, 25234,
                                           A) 7391167B) 10018165
2006-02-20   ########   30518   Type III   10 019 063 1110
2006-02-20   ########   30520   Type II    10 019 0631110
2006-02-20   ########   30568   Type III   6605632 ver. 2B4, ver. 2C3
2006-02-20   ########   30573   Type III              ver.
                                           731418, 7314192.0
2006-02-20   ########   29353   Type II               2511587, 3094043, 4040106, 110047, 110163.
                                           9033G0711, 9033G0712
2006-02-20   ########   28732   Type II    4000       All serial numbers. / Tous les numéros de séries.
2006-02-20   ########   28649   Type II    70402      N/A
2006-02-20   ########   29706   Type II               44690
                                           694, 695, 695X, 696
2006-02-20   ########   29726   Type II    8120       9934203
2006-02-20   ########   30176   Type II    6902S      0505280 Exp 11/20060505282 Exp 11/2006
2006-02-20   ########   30534   Type II    12-5382A 0305
2006-02-20   ########   28986   Type III   10100      N/A
2006-02-20   ########   30576   Type III   439770     M512129
2006-02-20   ########   30579   Type III   378020     M505223G
2006-02-20   ########   30583   Type III   N/A        H530052 (9/03), H530104 (9/01), H530402 (9/04), H53
2006-02-20   ########   30584   Type III              1544171
                                           ZIB6-80-6.0-60
2006-02-06   ########   30411   Type II               A) All lot numbers. / Tous les numéros de lots.B)
                                           A) 322000B) 322001C) 322075, 322076, 322077, 322078 All lot
2006-02-06   ########   30395   Type II               A) All serial numbers. / Tous les numéros
                                           A) 2L3105B) 2L3104, 2L3104RC) 2L3107, 2L3107R de séries.B) Al
2006-02-06   ########   30451   Type II    4R5701     H05C07053
2006-02-06   ########   30400   Type II               N/A
                                           0010206, 0010207, 0010208
2006-02-06   ########   29984   Type II               E1748482
                                           OBCS-111-15.0-M1
2006-02-06   ########   30364   Type III   N/A        N/A
2006-02-06   ########   30200   Type II    1.2E+10 17192402
2006-02-06   ########   30425   Type II    N/A        7661326, 7750674, 7750676, 7825637, 7860774, 7899
2006-02-06   ########   29271   Type II    V 3.10     0004
2006-02-06   ########   29631   Type II    FS-GT-OMNI W2073308, W2074628, W2076301, W2076843, W2076
2006-02-06   ########   30373   Type II    N/A        05G0760G, 05F1675G, 05G0556G, 04K2692P, 05A0754
2006-02-06   ########   29724   Type II    MX441B N/A
2006-02-06   ########   30429   Type II               Various lot numbers. / Numéros de lot variés.
                                           PCDB1, PCDD1, PCDG1, PCDH1, PCDJ1, PCDL1, PCDM1, PCDN1, PC
2006-02-06   ########   30345   Type I     8228595 240, 250
2006-02-06   ########   30413   Type II    N/A        Various lot numbers. / Numéros de lot variés.
2006-01-23   ########   30349   Type II               A) N/AB) N/AC) N/A
                                           A) 9D92-20B) 1E02-20C) 1E02-20
2006-01-23   ########   30291   Type II               A) All lot numbers. / Tous les numéros de lots.B) All lot
                                           A) 5C4212P, SPC4486B) 5C4466P, RPC4466
2006-01-23   ########   30350   Type II               2N1194, 2N3371, 2N8371B) 2N3703, 2N3706, 2N3710,
                                           A) 2N1191, A) UR254482, UR254763, UR255752, UR255919, UR261
2006-01-23   ########   30274   Type II               A)
                                           A) N/AB) N/A All lot numbers. / Tous les numéros de lots.B) N/A
2006-01-23   ########   29827   Type III              A) 035194, 055030, 065142B) 045172, 075112, K4011E
                                           A) K4004, K4005B) K4006, K4007C) K4008, K4009D) K4010, 045173
2006-01-23   ########   28400   Type I     906-018 041643 - 045124
2006-01-23   ########   30370   Type III   N/A        SN 04-0380, SN 04-0442, SN 04-0443, SN 04-0455, SN 0
2006-01-23   ########   28927   Type III              4177270, 4173920, 4154087
                                           373910, 373911, 373915
2006-01-23   ########   30387   Type III              100179K,
                                           7547002, 7547116 102737K
2006-01-23   ########   30386   Type III              Ver.
                                           629636, 6296372.0
2006-01-23   ########   29365   Type II    904-308 R0172 to/ à R0223 Inclusive / Inclusivement
2006-01-23   ########   29522   Type III   DF34       CORRECTION TO RECALL # 29522 PREVIOUSLY PO
2006-01-23   ########   30146   Type II    9825       E62001 to / à E62121 and / et E62124
2006-01-23   ########   30347   Type III              126
                                           L2KTW2, L2KTW6
2006-01-23   ########   30357   Type II    MCV 2763 N/A
2006-01-23   ########   30381   Type II    N/A        Y042005-1
2006-01-23   ########   30378   Type II    AT         2767, 2762
2006-01-23   ########   30212   Type II    SAM-300 05-2982, 05-5519
2006-01-23   ########   30366   Type II    SGD-12-70 W2048624
2006-01-23   ########   30024   Type II    N/A        T2370-0009, T2482-0081
2006-01-23   ########   29980   Type III   N/A        482974, 479366
2006-01-09   ########   28870   Type II               A) Various
                                           A) 682028B) 682147 lot numbers. / Numéros de lot variés.B) Vario
2006-01-09   ########   30116   Type I                 2M8163, DNM8153B) Tous les numéros de séries.B)
                                           A) 2M8153,A) All serial numbers. / 2M8151, 2M8161, DNM8151 Al
2006-01-09   ########   30211   Type II               A)
                                           A) N/AB) N/A DST-XLB) DST
2006-01-09   ########   30122   Type III   N/A        All lot numbers. / Tous les numéros de lots.
2006-01-09   ########   30127   Type III   N/A        6605641
2006-01-09   ########   28946   Type II    221952     5140549
2006-01-09   ########   30138   Type II                  9163000109, 9163000242, 9163000418, 9163000329,
                                             OVMU11, OVMU112
2006-01-09   ########   30202   Type II      N/A         Units with serial number beginning with 18412 . / Unité
2006-01-09   ########   30245   Type III     N/A         N/A
2006-01-09   ########   30256   Type II      N/A         N/A
2005-12-26   ########   28690   Type II                  30034, 32020P, 31425P, 32285P, 32293P,
                                             02H30, 02H31, 02H31-01, 91340, 91350, 91350-01. 30763N, 301
2005-12-26   ########   29495   Type II      91496       31942, 34856, 35209, 35296, 35747, 36239, 36555.
2005-12-26   ########   30026   Type I       JC6386      ST05G110
2005-12-26   ########   29708   Type II      N/A         ALS 09
2005-12-26   ########   30011   Type II      MP-28       H512601, H513801, H514001, H511801.
2005-12-26   ########   29285   Type II      MC-600CAN   MC-600CAN
2005-12-26   ########   28725   Type III                 All lots.
                                             010-545, 010-549 / Tous les lots.
2005-12-26   ########   29768   Type II      25215       930848
2005-12-26   ########   30009   Type I       N/A         Assorted batch numbers. / Différents numéros de lot.
2005-12-26   ########   29920   Type II      N/A         > 10 numbers .Contact Manufacturer. / >10 numéros. C
2005-12-12   ########   28731      Type II               A) 6835091, 6793496, 6765615, 6722845, 6560008, 64
                                             A) 20-606, 20-608, 20-610, 20-612, 20-613, 20-614, 20-616.B) 45-5
2005-12-12   ########   29595   Type II                  A) All ******************B) 2C8401, 2C8419, 2H84
                                             A) JC8401, JC8419lot numbers. / Tous les numéros de lots********
2005-12-12   ########   28383   Type II                  A) 5568, 453567073191C) 5909, 6121, 6133, 5603B) 4
                                             A) 455011002031B) 5573, 5602, 5780,453567900891D) 6838 E) CT
2005-12-12   ########   27872   Type II                  2N8378, 2N8399B) Tous les numéros de lots.B) All lot
                                             A) 2N8374, A) All lot numbers. /2C8519, 2C8537, 2C8546, 2C8571,
2005-12-12   ########   27968   Type II                   2M8163, DNM8153 / 2M8151, 2M8161, DNM8151
                                             A) 2M8153,A) All serial numbers.B)Tous les numéros de séries.B) Al
2005-12-12   ########   27840   Type I                    2M8163, DNM8153B) Tous les numéros de séries.B)
                                             A) 2M8153,A) All serial numbers. / 2M8151, 2M8161, DNM8151 Al
2005-12-12   ########   28841   Type II                  2N3706, 2N3710, 2N3712, 2N3714, 2N3716B) 2C5685,
                                             A) 2N3703, A) FC04055, FC05013, FC04057, FC05010, FC05001, FC0
2005-12-12   ########   29614   Type II                  A) All serial numbers.
                                             A) 2L3105B) 2L3107, 2L3107R / Tous les numéros de séries.B) Al
2005-12-12   ########   29230   Type III                 A) All lot numbers. / Tous les numéros de lotsB) All lot n
                                             A) JC5419, JC6419, JC8419.B) JC1182C) JC7462***************D
2005-12-12   ########   29531   Type II      N/A         A) 240285H, 261265HB) 220635H, 230555H, 240305H,
2005-12-12   ########   28842   Type II                  A) 77 27 25490, 25340, 25043, 25039, 25541, 25588,
                                             A) 73 91 167B)25285, 121
2005-12-12   ########   28896   Type II                  A) 25110B)
                                             A) 7391167B) 7134594 22422
2005-12-12   ########   28609   Type III                 A) A21127,
                                             A) N/AB) N/AC) N/A A21128B) N/AC) N/A
2005-12-12   ########   29790   Type II      3A60-16 17597M200
2005-12-12   ########   27850   Type II                  SK2046, SL2111, SP2621, TC2648, TC7050, TE2828, TG2
                                             AP-200, AP-300
2005-12-12   ########   29457   Type II      62900 60376 52234
2005-12-12   ########   29774   Type III     1G06-01 C800379, C800156, C800119, C800122, C800817, C800
2005-12-12   ########   28009   Type II                  21082M201, 22025M100, 16603M200, 17069M100, 22
                                             6C12-20, 6C12-25, 6C12-30
2005-12-12   ########   29633   Type III     N/A         S109011, S107087, S211027, S309100, S410134.
2005-12-12   ########   29554   Type II                  GFPG2409, GFPG2415, GFPH2024, GFPG2417, GFPG24
                                             888404, 888510, 888604
2005-12-12   ########   28948   Type II      232210      5118393
2005-12-12   ########   29567   Type II                  4344934, 4344978, 4344970, 5082344, 5111314, 5146
                                             305945, 305946, 305950.
2005-12-12   ########   29282   Type III     OWWR17 544359-544369, 544370, 544371
2005-12-12   ########   29588   Type II      91861       Software Version 8.00.04 SP2
2005-12-12   ########   27965   Type II      07G01-01 R04315A
2005-12-12   ########   29760   Type III                 120
                                             93111-01, 99103-01, 99106-01.
2005-12-12   ########   28691   Type III                 287AA, 30268AA, 30271AA, 30455AA, 17500AA96, 302
                                             01H01-01, 01H01-03, 01H02-01, 01H02-03, 01H03-01.
2005-12-12   ########   28545   Type III                 All serial numbers. / 01H02-03, 01H03-01.
                                             01H01-01, 01H01-03, 01H02-01,Tous les numéros de séries.
2005-12-12   ########   29781   Type II      1E66-03 20881M100
2005-12-12   ########   28453   Type III     OUPZ17 512689A
2005-12-12   ########   28962   Type III                 v1.0,
                                             731418, 731419 v1.1, v2.0
2005-12-12   ########   27880   Type II      50021       45580.28.01
2005-12-12   ########   29522   Type III     DF34        1BD6123, 1EJ6139
2005-12-12   ########   29738   Type III N/A         > 100 numbers .Contact Manufacturer. / >100 numéros
2005-12-12   ########   28990   Type III EC1001      All lot numbers. / Tous les numéros de lots
2005-12-12   ########   28330   Type II              US00202768, US00205040, US00204595, US00202850,
                                         M3535A , M3536A
2005-12-12   ########   29684   Type III             00016943, K5209.
                                         K5204, K5205, K5207, 00016965, 00018107.
2005-12-12   ########   29432   Type III HM34DC 27235, 27231, 27242, 27255, 25117, 27247, 27199, 251
2005-12-12   ########   29817   Type II              > 100 numbers .Contact Manufacturer. / >100 numéros
                                         SKU #9153641905, SKU #9153641906
2005-12-12   ########   28293   Type II              All lot numbers with 304CE and XXXCR. /
                                         160-5906, 167-8663, 810-7823, 812-7334, 825-9269 Tous les numé
2005-12-12   ########   29709   Type II  N/A         N/A
2005-12-12   ########   29101   Type II              44680
                                         694, 695, 695X, 696
2005-12-12   ########   29254   Type II              39490
                                         697, 698, 698X, 699.
2005-12-12   ########   28858            252585      161909, 161813, 161907, 161908
                                UPDATED RECALL #28858 PREVIOUSLY POSTED ON 2005-10-17. / Mise à
2005-12-12   ########   27891   Type III 6L119UL T2
2005-12-12   ########   29724   Type II  MX441B N/A
2005-12-12   ########   29255   Type II              3010544, OCS 135A, OCS 155A.
                                         OCS 115A, OCS 125A,3010545, 3010546, 3010547, 3010548, 3010
2005-12-12   ########   29642   Type II  V900-145 0500551000, 0401702000, 0400595000, 0300973000,
2005-12-12   ########   28979   Type II              > 10 numbers 2K00R4, 2K27R8, 2L96R2, 9102R12, HY3
                                         0F79R4, 1D69R9, 2B54R2,.Contact Manufacturer. / >10 numéros. C
2005-12-12   ########   28795   Type II              90000203, 90000179,
                                         951212, 951414, 951616, 953838 90000180.
2005-12-12   ########   28257   Type II  N/A         All lot numbers. / Tous les numéros de lots.
2005-12-12   ########   28997   Type I               AMXJ00514, AMXJ00387, AMXJ00512, AMXJ00513.
                                         1009-8003-000
2005-12-12   ########   28181   Type II  N/A         OM-302, OM-311, OM-312
2005-12-12   ########   28062   Type II              N/A
                                         Model / Modèle 6487800
2005-12-12   ########   28888   Type II              HEBF5011, HEBF5006, HEBF5005, HEBF5010, HEBF5004
                                         6600-0833-800
2005-12-12   ########   29386   Type II              42671
                                         00516, 09F29-20
2005-12-12   ########   28102   Type II  08F17-01 41755
2005-12-12   ########   29256   Type II  SSH 200 3007301, 3010432, 3007300, 3010091.
2005-12-12   ########   29634   Type III N/A         M501191
2005-12-12   ########   28701   Type II              All serial
                                         2L3113, 2L3113R numbers. / Tous les numéros de séries.
2005-12-12   ########   28840   Type III 7580033 1011, 1025
2005-12-12   ########   29661   Type III             Greater Supérieur à 2444.
                                         Greater than 2444 /than 2444 / Supérieur à 2444.
2005-12-12   ########   29298   Type III             Version
                                         Vision (Version 6.5) 6 and higher. / Version 6 et plus.
2005-12-12   ########   28403   Type II  8892382 Generations 18, 19, 20, 21, 23.
2005-12-12   ########   28709   Type III 6801711 01-5846, 01-6036, 01-6239.
2005-12-12   ########   27886   Type II  874 4468 710
2005-11-28   ########   29551   Type III             2008-07
                                         1624WB, 1626WB TM, 2008-06 TC
2005-11-28   ########   29412   Type II              A) All serial numbers / Tous les numéros ARENASPX-HC
                                         A) ARENASPP-DHB) ARENASPX-BDH, ARENASPX-BH, de lotsB) All se
2005-11-28   ########   29468   Type II              A) N/AB) N/AC) CK-100
                                         A) N/AB) VT01-A, VT01-BC) N/A
2005-11-28   ########   29533   Type II  3.53E+09 Serial # below 526 10 999 999
2005-11-28   ########   29426   Type III N/A         H480001-H484301
2005-11-28   ########   29427   Type III N/A         H480001-H484301
2005-11-28   ########   29458   Type III N/A         H480001-H484301
2005-11-28   ########   29377   Type II  SK400       277755
2005-11-28   ########   29555   Type III OQMP11 35442, 35568, 35730, 35780, 35902
2005-11-28   ########   29279   Type II  ITCS42      220292
2005-11-28   ########   29564   Type II              043836, 040430, 044-18, 040432, 044019
                                         BC8J-4B00-001, BC8J-4B00-002
2005-11-14   ########   29099   Type II  LS7500      More than 10 / Plus de 10.
2005-11-14   ########   29098   Type II              00502005300
                                         A) C9863B) A) N/AB) N/A
2005-11-14   ########   29302   Type III OVLI11      341237, 251449, 210579, 210613A, 331087, 210582, 4
2005-11-14   ########   29234   Type II               N/A
                                           241.063, 241.065
2005-11-14   ########   29274   Type III   6605632 N/A
2005-11-14   ########   28495   Type II    N/A        02l32657
2005-11-14   ########   28456   Type III   40-2171 N/A
2005-11-14   ########   29338   Type III              N/A
                                           2137257, 46-260805G1, 46-281380G5
2005-11-14   ########   29174   Type III   021-139 SW 2779, SW 2764
2005-11-14   ########   29269   Type III              N/A
                                           378284, 388293
2005-11-14   ########   28866   Type II    370        UL370
2005-11-14   ########   29284   Type III   6801709 01-5919, 01-6032, 02-6284, 02-6400.
2005-11-14   ########   29104   Type II    8633893 1159, 1104, 946, 2617, 1744, 1708, 1712, 638, 1216, 17
2005-11-14   ########   28978   Type III   9687-12 17270M100, 18177M300
2005-11-08   ########   29428   Type III   N/A        H480001-H484301
2005-10-31   ########   29078   Type II               A) 701594. B) 696918, 702865, 714615.C) 678929, SO
                                           A) SOP30ACXXXB) SOP30LEXXXC) SOP30THXXXD) SOP30ARXXX,684
2005-10-31   ########   29079   Type II    62-7004 62-404296
2005-10-31   ########   29131   Type II    A4674A QZ00836, QZ00843
2005-10-31   ########   29018   Type III              39480
                                           697, 698, 698X, 699
2005-10-31   ########   29211   Type III   SQI-MIC-SY version 6.1
2005-10-31   ########   28923   Type II    9.81E+09 N/A
2005-10-31   ########   28954   Type III   Treatment H460100, H462016, H462017, H462018, H462019, H46
2005-10-31   ########   28956   Type III   Treatment H460100, H462016, H462017, H462018, H462019, H46
2005-10-17   ########   28993   Type III              A) 1006, 1018,
                                           A) 7414806B) 58950003 1046, 1065, 1067, 1069, 1070, 1072, 11
2005-10-17   ########   28480   Type II               A) N/AB)
                                           A) N/AB) N/AC) N/A N/AC) N/A
2005-10-17   ########   28697   Type II               A) 96CP2556B) 96DP0932, 96DP1701, LUD09040, LUD0
                                           A) LUE12060B) LUD06030, LUD08030, LUD08060, 96DP1702, 96CP
2005-10-17   ########   29016   Type I                A) 100703, 40625,
                                           A) M00572650B) M00572600 7135384.B) 60903, 40710.
2005-10-17   ########   28749   Type II               A) All Below V-G157-31585 Except :V-G156-31274, V-G
                                           A) N/AB) N/AC) N/AD) N/A
2005-10-17   ########   28967   Type II               A) N/A C) N/AD) N/AE) N/AF) 482G) 1294, 1295, 1296H
                                           A) 1192B) 982C) 1292D) 985, 986E) 882F)N/AG) N/AH) N/AI ) N/AJ)
2005-10-17   ########   28883   Type III              A) 10147,
                                           A) N/AB) N/AC) N/A 10244, 10255, 10611, 10369, 10666, 10667.B
2005-10-17   ########   28918   Type III               B) OQIP13
                                           A) OQIM13 A) 083644, 083644A, 083644B, 083644BB, 083649, 083
2005-10-17   ########   28854   Type III              A) PN950-0101 Rev1.7, PN950-0108 Rev1.7a, Ver
                                           A) IDI-2002-001B) IDI-2003-003, IDI-2004-005, IDI-2005-007 1.6, V
2005-10-17   ########   28916   Type II               A) All lot numbers. / Tous les numéros de lots.B) 10-319
                                           A) 10-311, 10-312, 10-314, 10-315, 10-316, 10-317, 10-318, All lot
2005-10-17   ########   28909   Type II               A) v. 4.5/4.6 B)
                                           A) 476501B) 476100C) N/Av. 4.5/4.6 C) v.4.5/4.6
2005-10-17   ########   28929   Type III   3.14E+09 N/A
2005-10-17   ########   28938   Type II                B4218-20
                                           B4218-100,527263, 527264
2005-10-17   ########   28848   Type II    N/A        N/A
2005-10-17   ########   28887   Type III   213330     52060072
2005-10-17   ########   28980   Type III   DF45A      EG6194, EN6210
2005-10-17   ########   28926   Type III   992133     31205
2005-10-17   ########   28919   Type III              758738F,
                                           6607077, 6607098 758739F, 758740F, 760943F
2005-10-17   ########   28708   Type II    31008      FS2089, FS9914.
2005-10-17   ########   28711   Type III              13600. 13610, 13620, 13630, 13640
                                           356, 357, 357X, 358
2005-10-17   ########   28858   Type II    252585     161909, 161813, 161907, 161908
2005-10-17   ########   28920   Type II    LLP7       C4-03777, C4-03761, C4-03947, C4-03948, C4-03930, C
2005-10-17   ########   28766   Type II    IOSS411 276818
2005-10-17   ########   28721   Type II               >10 numbers; contact manufacturer / > 10 numéros; co
                                           3805-014, 3805-015
2005-10-17   ########   28924   Type II    B1017-143 12APR06
2005-10-17   ########   28767   Type III   2345       27461
2005-10-17   ########   28981   Type II    10019063 1110
2005-10-03   ########   28463   Type II               A) 60521374, 60551766, 60702094, 60708049B) 60549
                                           A) N/AB) N/AC) N/AD) N/AE) 333603, 333606, 333611, 333612, 33
2005-10-03   ########   28864   Type II               A) B)13027030 - 13044734 (INCLUSIVE / INCLUSIVEMEN
                                           A) N/AB) NI75TCBH, NI75TCCH, NI75TCDH, NI75TCFH, NI75TCJHC) N
2005-10-03   ########   28705   Type II               A) N4H201, N4K213, N4L82, N4M302, N4M522, N4K14
                                           A) 120039, 120089B) N/A
2005-10-03   ########   28901   Type III              A)
                                           A) N/AB) N/A N/AB) N/A
2005-10-03   ########   28907   Type I     N/A        N/A
2005-10-03   ########   28833   Type II               All Lot numbers / Tous les numéros de lots.
                                           4306-46, 4306-52-46
2005-10-03   ########   28703   Type II    FORCE FX-CF4K34633A, F4K34643A, F4K34743A, F4K34820A, F4K3
2005-10-03   ########   28876   Type II    5936518 112780, 112800, 112530, 112593, 112595, 112607, 11
2005-10-03   ########   28908   Type III   IM3632     07
2005-10-03   ########   28765   Type III              05F, 05G
                                           3704, 3704D3, 3714
2005-10-03   ########   28875   Type III              M410461, M309120, M404210, M410440, M404033
                                           469985, 471225
2005-09-19   ########   28468   Type II               A)Serial number
                                           A) 280000, 999001B) N/A starting with 05041164, Serial number
2005-09-19   ########   28751   Type I     KS81-1055 KS81-1055
2005-09-19   ########   28819   Type II               4004
                                           4535 679 72021
2005-09-19   ########   28664   Type II    64999      N/A
2005-09-19   ########   28831   Type I     N/A        465131
2005-09-19   ########   28832   Type II    N/A        N/A
2005-06-27 ########     28368   Type II    OBI         H48001-H483349
2005-06-27 ########     28371   Type III   91DIC       M405028
2005-06-27 ########     28372   Type II    75UJM       446-508
2005-06-27 ########     28448   Type III   439770      M501206
2005-06-27 ########     28455   Type III   7546979 1130101K, 113102K
2005-06-27 ########     28459   Type I     N/A         9016e0491
2005-06-27 ########     28475   Type II                104876, 007842, 008839, 2156311, 2225107, 3020132,
                                           384424, 384426
2005-06-27 ########     28479   Type II    222120      5041959
2005-06-27 ########     28465   Type II    5.61E+08 417519, 417520, 418483.
2005-06-272005-05-30    28452   Type II                A) YF9CJ4000, Y5PPD4000, Y18BR4000,
                                           A) N/AB) N/AC) N/AD) N/AE) N/AF) N/AG) N/AH) N/A Y51F64000,
2005-06-27 ########     28434   Type II    M2540A US20505857, US20505858, US20505901, US30505950
2005-06-27 ########     28435   Type II                A) All lots without
                                           A) 4325B) P4340A, P4341B yellow on stickers and trays. / Tous les
2005-06-27 ########     28437   Type II                 BaseB) Omnibed
                                           A) ElevatingA) HDHF50136, HDHF50146, HDHF50037-HDHF50043
2005-06-13 ########     28404   Type I                 161798, 161763, 161849.
                                           259847, 259846.
2005-06-13 ########     28354   Type III   N/A         A24000095, A24000088, A24000063, A24000043, A240
2005-06-13 ########     28207   Type II                161710, 161797, 161655, 161740, 161849.
                                           259846, 259847
2005-06-13 ########     28328   Type II                N/A
                                           291070, 291071
2005-06-13 ########     28335   Type II                A) All serial
                                           A) 2M8063B) 2M8064 numbersB) All serial numbers
2005-06-13 ########     28382   Type II    1M8550R 12040401AB TO 12040420AB, 12050501AB and later /
2005-06-13 ########     28339   Type II                A) 376078, 376079, 376155, 376156, PE, BA3180-171
                                           A) BA3180-151 AE, BA3180-151 FE, BA3180-151376220, 376223 to
2005-06-13 ########     28375   Type II    P1400       N/A
2005-05-30 ########     28245   Type II                A) 4173087, 4181398, 3224096, 4110295, 4314481, 433
                                           A) 405138, 405140, 409442B) 405078, 405170, 405234
2005-05-30 ########     28191   Type III               A
                                           A) N/AB) N/A) 09092B) 09092, 09092A
2005-05-30 ########     28266   Type III   N/A         N/A
2005-05-30 ########     28184   Type III   N/A         version 1.10, version 1.20, version 1.21
2005-05-30 ########     28227   Type II    JC7566      All lots / Tous les lots.
2005-05-30 ########     28244   Type II    04170 04001204170.21.11
2005-05-30 ########     28275   Type III   D154ATG N/A
2005-05-30 ########     28230   Type II    SBA30FCXXX  692985
2005-05-30 ########     28232   Type II    N/A         SN H080049, SN H080053, SN H080059, SN H080060
2005-05-30   ########   28256   Type II    N/A        T0502131X, T0407280X
2005-05-30   ########   28257   Type II    N/A        All lots / Tous les lots.
2005-05-30   ########   28217   Type II    FR-093     20256, 20300, 20303, 20306, 20310, 20311, 20312, 203
2005-05-30   ########   28224   Type III   N/A        GY0412099, GY0501023
2005-05-30   ########   28214   Type II    MCT 9471 10009, 10026, 10035, 10066, 10067, 10068, 10072, 102
2005-05-16   ########   28176   Type III              A)5408-0301009,
                                           A) N/AB) 8415957, 8728581 7130-0401006B)N/A
2005-05-16   ########   28123   Type II    N/A        All Lots / Tous les lots.
2005-05-16   ########   27988 Type II                MF4016638, MF4031358, MF4052272, MF4062965, M
                                           PT-12709-WC, PT-65709-HFWC,PT-65709-W,PT-65709-WC
2005-05-16   ########   28131   Type II    N/A       N/A
2005-05-16   ########   28168   Type III              491-4461
                                           491-4460, All Lots / Tous les lots.
2005-05-16   ########   28152   Type II              04/21/1
                                           GM11003730, GM11004680
2005-05-16   ########   28098   Type III   N/A       9631, 9632, 9633, 9634, 9635, 9636, 9637, 9638, 9639,
2005-05-16   ########   27990   Type II    71343200 04FM05797
2005-05-16   ########   28133   Type II              7337514, 7337515, 7337516, 7337517, 7350604, 01938
                                           019304, 019306, 019381, 019382, 019383, 019384, 019386, 73567
2005-05-16   ########   28132   Type I     N/A       3510050299, 3510050304, 3510050306, 3510050293, 3
2005-05-16   ########   28037   Type III   71336500 04LM06164, 04LM08098, 04LM10653, 04LM08099, 04L
2005-05-16   ########   28084   Type III   495-1410 10573162
2005-05-02   ########   28028   Type II              A) GD10275B) GD810101
                                           A) 2T0770 B) 2T0783
2005-05-02   ########   28038   Type II              A)N/AB)N/A
                                           A) DYNJ21718B)DYNJ21721, DYNJ21722
2005-05-02   ########   28057   Type II              693449
                                           SBA30SPPAC, SBA30SPXXX
2005-05-02   ########   28032   Type II    N/A       1362368, 1394015
2005-05-02   ########   28018   Type III   BCP-7A    1331630
2005-04-18   ########   27964   Type III             25006, 25076, 20070, 20215, 32070, 35195, 35216, 352
                                           A)7412807B)5904441C)5904466D)7007755
2005-04-18   ########   27948   Type III   5904466 20163
2005-04-18   ########   27826   Type I     MABPDE 20031001, 20031103, 20040202 , 20040404 , 2004060
2005-04-18   ########   27919   Type II      1957153 4011, 4034 , 4063
                       Reason for Recall                                                                           Medical Devices
Potential risk of end-users inadvertently taking a BD Q-Syte device from BD Nexiva product or package, and placing Cla    Hazard it
There are small slits on the backsides of Vitek 2 AST-N085 lot 345158910 foil pouches near the seam separating the desiccant
                                                                    The numerical designation, i.e., Type I, II or III, assigned by H
                                                                                be displayed in the indicate the relative degree of
In the ERM session, when results are of coded text type, incorrect data couldparticular product to tool tip on the current result fie
                                                                Type a modification of the value of a result that has already b
Using F8 key in the ERM session to add a combined test can result inI:thesituation in which there is a reasonable probability that
                                                                                                                    health consequ
Elecsys Vitamin D3 Monoclonal Assay shows deteriorating traceability to the reference method and a negative bias when compa
                                                                         a situation in not specify the units of measure a produc
                                                                Type II:(SHBG) does which the use of, or exposure to,to be use
The instruction for use (IFU) for access Sex Hormone Binding Globulin
                                                                                                the probability of serious adverse h
                                                                Type III: a situation in which the use of, or exposure to, a alkali
Beckman Coulter Inc. has confirmed reports that black/brown particulates were observed in some bottles of the creatinineproduc
                                                                   I and II include situations where a product which does the dim
Trays used to package the Pleatman Sac product had cracks and/or dimples on them. Further investigation revealed thatnot hav
                                                                value is promoted T72 Insertway that avoidanceoversized by a m
Stryker Orthopaedics has become aware that there is the potential for the Scorpio in such a Tibial Trials to be of recognized th
Stryker Howmedica Osteonics has become aware that there was a cross mix between the Osteonics Series 7000 Total Kneedea            St
During manufacturing, the aspiration probe was hitting the top portion of the vent head assembly and would not go all the way do
                                                                              Source:http://www.hc-sc.gc.ca/dhp-mps/compli-confo
Bio-Rad notifies in2it users that when performing in2it testing at altitudes above 1 000 meters (3 280 feet) they may obtain high
Philips has received reports that when changing the anaesthetic gas monitor water trap (M1657B), the manifold seals on the Ph
Stryker Instruments has revised the instructions for use (IFU) for the Painpump2 Block-Aid.
The possibility of reduced adhesion between the patties and the blue radio-opaque x-ray stripe. This may result in the x-ray strip
A calibration factor close to or even below 0.8 can be observed with reagent kits stored on-board for more than four weeks. In s
The recommended cleaning procedures for the Coaguchek XS and Coaguchek XS Plus systems may cause a meter malfunctio
Philips has become aware that users may not fully understand the advanced features related to primary ECG lead configuration
Ortho Clinical Diagnostics has received several customer complaints of lower than expected albumin results for samples that we
Potential leaking at the return luer connection on two manufacturing lots of COBE Spectra White Blood Cell Disposable Tubing
There are Excyte ESR tubes in the field that do not fit properly in the Excyte sliders. The product will not be replaced. This produ
Siemens Healthcare Diagnostics confirms lower than expected specificity rates that may increase the frequency of false positive
Beckman Coulter has confirmed that IGFBP-3 measurements using IGFBP-3 IRMA Kit (REF DSL-6600) lots identified may resu
Under delivery reports occurring during clinical use under low rate settings (less than 10ml/hr).
During system initialization when pipettors are washing, if sample or reagent area flap are opened, the shaker rod may stop mov
Smith & Nephew has received complaints in which a small number of patients have received skin burns associated with the usa
Abbott has determined that the i-Stat level 2 Control Value Assignment Sheets contain the incorrect range for PCO2, blood urea
The Dermal SR Roller (transdermal delivery microneedle therapy) is being recalled because of lack of assurance of sterility.
Some product may have been mislabeled on the secondary carton (yellow carton) and there is a discrepancy with the primary pa
The impacted lots show unusual systematic negative bias of 15% when used together with serum based calibrators and controls
The package insert for the Precicontrol Universal has been modified to exclude the TG component from the storage stability of 3
Directions for use for the affected lots do not include certain language previously requested.
Siemens received a report on a system with 160MLC, where a misalignment of treatment fields was detected during quality assu
Synchron Systems Glucose Reagent (GLU) when used in conjunction with Unicel DXC and Synchron LX instruments may give
Maquet/Datascope has identified an uncharacteristic increase in the number of screen display related issues reported on the Int
Beckman Coulter has received reports of increased recovery of control and patient samples using the lots of Immage BUF1(with
When reviewing XIO plans created in relative dose mode in Focal Plan Review the isodose distribution is displayed incorrectly. U
The patient scan position is being confused with the treatment orientation of the patient.
There is a possible sterility issue with one of the components of the kits which may contain burkholderia multivorans. B. multivor
The safe connect component of some FL-601-97 cables could separate from the cable during use due to inadequate gluing of th
Abbott has determined that 8 cartridge lots may generate falsely elevated international normalized ratio (INR) results. Internal st
Some devices were distributed in Canada with lead configuration programmed to a factory nominal value of unipolar even thoug
The PD Access 18 Gauge Vascular Access Device recall is being initiated due to a potential for the packaging of the device to b
Navilyst Medical, Inc. has become aware that insertion of the non-coring needles (provided with the devices) into the septum of
A certain number of single dose blister packs of Futurabond were dispatched with potentially only one of the two compartments
The instructions for use (IFU) sent with the product prior to 2004 indicates the allowed number of sterilization cycles is 100. The
Specific Chemiluminescent Substrate lots have been shown to introduce a positive and/or negative bias in both controls and pot
Some of the syringe kits exhibited a hole in the packaging. This condition could compromise the sterility of the internal compone
Smith & Nephew has found that the collet slot in the cutting blocks is too shallow, not allowing the collet to sit flush. The 0.968" s
A number of Hemochron Signature Elite instruments were inadvertently equipped with a class II laser barcode scanner instead o
Heartstart HS1 and FRX automated external defibrillators (AED‟s) manufactured in March 2010 contain a relay that may not me
Internal investigations have determined that certain lots of the product were marketed in Canada utilizing the incorrect reference
Architect Sirolimus Reagent lot 80162M100 has exhibited an increased frequency of barcode read errors due to the print quality
Ortho Clinical Diagnostics has identified a software anomaly when using Ortho Provue software version 3.1. Internal testing has
Ortho Clinical Diagnostics (OCD) has determined that the Ortho Provue Analyzer does not detect that different lots of reagent re
Sterile barrier may contain seal defects. The breach of sterility could lead to a device being non-sterile. Boston is not aware of a
The T-connector component of the dual low-pressure connector tubing may be susceptible to cracking or breaking and leaking.
The Aplio XG Ultrasound System (SSA-790A) does not conform to one requirement of clause 15B, power supply section, of IEC
An extension of HC#50115 recall. After filing report 50115, further reports emerged of additional customer experiences for fractu
Due to intermittent shortcuts inside the Velara Generator, a system lock-up might occur that can only be resolved by a warm or
The discharge switch on the handle in affected devices may stick or fail to actuate and prevent the user from delivering defibrilla
Beckman Coulter has confirmed reports of potential dilution of reagent vials on the Prepplus or Prepplus 2 systems. The problem
The printed circuit board assembly responsible for blood pressure measurement and analysis (material number 400387, referre
Beckman Coulter has confirmed that different results have been obtained from the same patient samples assayed on Access/A
Potential for sporadic damage reagent cap hinges on different Elecsys products lots. In consequence, the affected cap may not
Potential for sporadic damage reagent cap hinges on different Elecsys products lots. In consequence, the affected cap may not
Alert issued on reports of sparking, charring, and fires on power cords reported by Hospira & Abbott Nutrition which are similar t
This update instruction improves the quality and reliability of the Axiom Iconos ND/Axiom Iconos R200 system with the following
Beckman Coulter has reported intermittent suppressed patient results and an increased incidence of IND flags associated with t
Beckman Coulter has determined upward shift in patient and control recovery with Synchron Systems Apolipoprotein B (APOB)
Cryostat serial 45847 may have been built using an incorrect cable with undersized diameter. It could potentially cause cable to
Steris has learned that some customers may be storing objects, including surgical items and table accessories, on the base and
Steris has learned that if not used properly an accessory attached to the 9" Urology Extension may become unintentionally detac
Siemens Healthcare Diagnostics received a customer complaint regarding Versacell and the Advia Chemistry 1800 System. If th
Devices labelled with the incorrect instructions for use. The product is a breathing filter and it is labelled as a heat and moisture
The manufacturer reported that the pressure contained within the Elution Buffer vial may expel the ruber stopper upon removing
Test strips may provide falsely low glucose results when the glucose level is higher than 22.2 mmol/l.
The manufacturer has confirmed that some reagent-tips may develop cracks in the grey plastic handle (upper region of the R-tip
Affected kits may contain a disc labelled with the incorrect batch number 625731 instead of batch number 666804.
During stability testing an out of specification PH was found prior to the 12 month expiry date in the various product code glass b
Under certain conditions enclosure leakage current exceeds allowed limits. The measured enclosure currents can be 8 - 10ma.
Siemens Healthcare Diagnostics received customer complaints regarding Dimension Vista System, Chemistry 2 Calibrator KC1
Product will not set because it was mispackaged with an incorrect catalyst.
Bath and shower seats manufactured by Maddak between May 1 and July 7, 2009 can tip over or collapse under the weight of th
Several recent lots of Dycal may exhibit faster setting characteristics than is normal for these products. The catalyst may also se
Lane 27 (R04-28A) in the DRB1*04 SSP Unitray Kit lots and batches mentioned, was found to produce a false positive band in t
Stryker has become aware that there is potential for the brochure to mislead the user into choosing a non-suitable extraction ins
During the assembly of the product(Dyonics 25 Fluid Management System-Patient Tube Set), the check valve was assembled b
As result of an internal audit, Siemens determined that the digital electron variable applicator is compliant with IEC 60601-2-1 wi
Software error after running the following workflow steps 1)zoom in live image, 2)store a respective clip, 3)go to exam review or
The database conversion utility used during the Varian 4D sites upgraded to 1.60W3, 2.0T2, 2.10l5 and 2.10M7 errantly change
Products contain bacterial contamination and precipitate.
A raw material used in the production of some Biomerieux products may not produce the correct biochemical reactions with qua
The lubricating jelly packet contained within the kit may have an expiration date that expires prior to the expiration date stated on
Advisory notice to notify affected customers of a software error encountered after running through the following workflow steps 1
Immucor is investigating complaints of sporadic no type determined interpretations (NTD) due to unexpected equivocal or unexp
Possibility of rotor disrupting and pieces of a rotor and sample ejecting from the housing. This may result in serious personal inju
Customers are observing an increase in the negative control values and/or grayzone/reactive (GZ/R) results when using the Arc
This field safety notice serves to notify customers that lane 42 (A24-34D) in the affected A High Resolution SSP Unitrays does n
Primer mix PML69A contained in the named kits may produce a weak true positive band at the correct base pair size of 135BP.
The parts were manufactured with the external flat aligned with the point of the hex instead of the flat of the hex.
During radiotherapy planning, the Hi-Art system modifies the planning image to replace the couch. In some cases, the patient's
Steris has learned that some customers may experience premature bulb failures due to loosening of wires and overheating of th
Rollators manufactured prior to October 30, 2008 may experience a weakening just below the weld on the rear frame which cou
Rollators manufactured prior to September 18, 2008 may experience a weakening just below the weld on the rear frame which c
Sterile barrier in the catheter packaging (outer pouch side seal) of the affected products may be compromised.
Products have deteriorated since manufacture and may fail to support the growth of streptococcus pneumoniae.
The manufacturer has issued a field safety notice to inform customers of an increase in revision rates for the Depuy ASR Acetab
Bulk-packaged rolls of Micropore Surgical Tape may exhibit the same inconsistent performance that was observed with single u
It was observed that there were a higher than expected number of false positive results with lot A090504Z and the presence of h
1. Incorrect imaging resulting from 3rd party digital image (Dicom) incompatibility. 2. Potential incorrect patient identification on r
Manufacturer is replacing these adaptors with new, more advanced product, which include surge protection hardware that will re
Measurement values provided by Seno Advantage Workstations 1x. 2.0 & 2.1 may be incorrect when applied to magnification im
Customer complaints regarding Dimension Vista Systems connected to a Streamlab Analytical Workcell where it has been obse
UA233, batch 154107, was incorrectly labelled with an expiry date of August 28, 2011. The correct expiry date is November 29,
Stryker has identified a need to provide specific instructions for initiating power to the Calcar Planer prior to engagement with bo
There is an intermittent series of events in which a print or store event failure may cause the following to occur: A) The last imag
Sterile barrier in the packaging of affected product may be compromised. Pouch seal (top seal) may be breached.
Sterile barrier in the packaging of affected product may be compromised. Pouch seal (top seal) may be breached.
Bacterial contamination (Pseudomonas mendocina) in the affected device.The device is a cell separation media and in the repo
The stretchers have the potential for the bushing in the braking system to fracture, which could result in the brake/steer pedal se
Packaging for the applicable devices may not include a written copy of the product directions for use.
A welded seam at the joint of the spring-loaded arm of the surgical light may brake and the light head may become disengaged
The product, GT Obturators, GTOB20042, lot 012709123 was found to contain mixed instruments, size 20, taper .04 (20/.04) an
Hypergel 5 gram, product code 360500, lot numbers 08d22-156-32913 and 08d22-157, have been distributed with a lot number
This action is being conducted because a small quantity of titanium alloy was discovered to have a discrepancy from the alloying
Table locks may not actuate, causing tabletop to unexpectedly float in either the lateral axes or both the longitudinal and lateral a
Synthes (Canada), Ltd. was notified by their supplier, Synthes (USA), of six complaints reported outside the US associated with
Siemens Healthcare Diagnostics received customer complaints regarding instabilities of high sensitivity C-reactive protein adjus
Sorin Group Italia has recently identified a weakness in the plastic packaging tray used for the Revolution Centrifugal Blood Pum
Intuitive Surgical Inc. observed an electronics subsystem failure that resulted in partial intermittent closure of the instrument grip
Terumo Cardiovascular Systems has received three reports of tubing disconnecting from the pump inlet of the Sarns Disposable
1. Moulding flash during manufacturing of T-piece at supplier caused out of specification aperture. 2. Severity in risk analysis co
The Connection Bracket show too much mechanical play at the operating room table interface for some procedures. The cause
Update: The manufacturer now requests return of the affected devices. A sufficiently worn/damaged Universal Cable M
Update: The manufacturer now requests return of the affected devices. The manufacturer has determined there is a rem
Nobel Biocare received several complaints from customers. After investigation it was determined that one batch of Impression C
Excessive strain may cause impairment of the interlocking between the arm joint and surgical light. Inappropriate handling may
Under certain conditions the software falsely elevated the results particularly if the preceding serum sample has a higher volume
Tubing disconnecting from the pump inlet of the disposable centrifugal pump during cardiopulmonary bypass.
Ortho Clinical Diagnostics is aware of one confirmed report of misreported patient results with the Engen Laboratory Automation
Five complaints involving braze joint failures of AdvanSync Telescopic Rod Assemblies resulting in a recall.
Received customer complaints regarding inaccurate results with the Bun Flex Reagent cartridge lots 09154AE and 09187AA.Th
The product is labelled as 25 mm in length but the files are actually 31 mm in length.
The company has become aware that there is the potential that over time, a buildup of surgical waste on the receptacle bearing
Amplatz PTFE-Coated Guidewires, part number 13BX, sold as lot 96158DB, may have been mis-packaged with product from lo
Possibility of the balloon rupturing during use.
Advisory letter was sent to customers of Revlite System with Revision E1 software, declaring that if PTP keypad is pressed while
Sterile barrier in the packaging of the affected product may be compromised. It has been reported that the outer pouch seal may
On some units of the Manual Pulmonary Resuscitator (MPR), the duckbill valve and retention ring inside the patient valve housin
There is a slight possibility of outer pouch failure during shipping, which could result in the introduction of an inner pouch having
Cover caps exhibited visible cracks post sterilization. Testing indicates the integrity of the packaging was maintained by an inner
All affected product is packaged within a vial. Boston Scientific has determined that, for affected products, the sterile barrier in th
There is potential for a crack on the front pivot of the Acrobat 2000 spring arm installed with a Blue 130 series surgical light that
It is believed that vast swings in environmental conditions can impact catheter products over time. Improper storage may cause
A potential of a single image of a series is displayed "distorted" after loading to a viewing application.
Potential loss of single image data of prior examinations when archived to network-attached storage (NAS) or hierarchical stora
After further review it has been determined that this action by the manufacturer is not considered a recall under the de
The recall was initiated due to recent tests that indicated some Midas Touch Needle Electrodes with modified tip might have an
Under certain circumstances a restriction of the flow of carbon dioxide gas within the handle may result in a less than optimal tem
An incorrect sensitivity limit has been assigned which is reagent specific and could cause results to be erroneously elevated bet
If an auto port is created for a beam on focal, the plan sent to XIO and the beam edited, it is possible the graphic beam represen
Potential software problem with Acuson and Sonoline Antares systems product version 5.0 with cardiac option installed below so
In Europe, Hagg-Streit received 3 reports concerning leaking Tonometer Prisms. A known reason of failing Tonometer Prisms is
The Renin Activity Control provided with the kit has an incorrect range printed on the label. Printed range on the label is 5.5 - 10
To inform customers about a potential issue, when receiving the multiple PSV measurements from some ultrasound systems, th
When using combination of 2D-compound resolution imaging (CRI) and a pulsed wave Doppler single gate (PW) with steered D
This recall was initiated as the product description included the word 'captured' and this was not a 'captured' screw. This could c
Fractions delivered on the Artiste might not be recorded in Lantis and subsequently patients might be mistreated.
Notifying users in Canada of updating cleaning instructions for the IW900 Series Infant Radiant Warmers. The inclusion of the re
Design modifications were made to the Neuron Delivery Catheter in March 2009 to improve the catheter kink resistance. Penum
When interfaced via A 9015 cable to an external data collection device, A 9004 monitor configured with CCAP 1.13 software wil
Specific product codes and lot numbers of the Endo Femoral Aimers may have been improperly marked indicating the wrong siz
Packaging integrity may be compromised as a result of transportation and distribution of the products.
Lack of surface treatment on one of the gears of the transmission gearbox.
The mixed standard component of the Therascreen Mutation may sporadically generate out-of-range high results when tested w
The online TDM Gentamicin assays may generate falsely elevated control and patient results when used with the current lot of P
The Rabbit Kidney Culture(pRK), which consisted of a monolayer culture of rabbit kidney cells used to grow viruses from a patie
Ethicon is conducting a voluntary product recall of all lots of Gynecare Morcellex Tissue Morcellator due to the potential for the d
Notifying users in Canada of an updated test procedure for the power-fail alarm of the IW900 Series Infant Radiant Warmer. Th
Results passed on integrating lab systems may be erroneous when using competitive tests, if they are located outside of the sta
The Revision "H" software calculated esophageal amplitudes incorrectly when the user generated a report. There were no issue
Lane 23 in the 'A' high resolution SSP Unitray, lot and batch number identified, will produce a false positive band at the correct b
Smith & Nephew was made aware that all parts were missing the laser etching as identification information.
This action is being conducted because the part number on the locking plate (Zimmer Periarticular Locking Plate System distal l
Specific lots of PDS II (polydioxanone) Absorbable Sutures are being recalled because some of these products may have a sma
Advanced Sterilization Products (ASP) is sending a letter to all Automated Endoscope Reprocessor (AER) customers to reinforc
Operator's manual does not warn against the unintended use of Apexpro Telemetry to monitor SPO2 without concurrent ECG m
The threaded connector of the battery clip housing can become loose from the battery clip housing thereby creating a potential t
The Reflex Hybrid Screw Extractor Inner Shaft was reported to fail at the threaded tip and fracture in the head of the screw. The
The protective coating around certain electrical wires inside the Trinest Incubator/Shaker may be worn out due to contact with a
Some of the needles may exhibit an exposed sample chamber due to extended stylet length from a loose hub connection, resul
Potential limit switch failure could occur due to collision between lateral plane of Innova positioner and other equipment, which m
Medtronic has initiated a field action to notify managing and implanting physicians of Medtronic per cutaneous leads for spinal co
This action is being conducted because packages from the identified lot should contain style 5 (trocar-style three point) Steinma
The mixed standard component of the Therascreen Mutation Kit may sporadically generate out-of-range high results when teste
When the chair back was returned up to the 'patient entry / exit' position, a pinch existed between the moving chair back suppor
There is evidence of potential microbial contamination in some vials of complement control cells (lot # 32616), based on gram s
Synthes (Canada), Ltd. was notified by their supplier, Synthes (USA), of six complaints reported outside the US associated with
The manufacturer has determined there is a remote possibility that the device may self activate.
Zimmer Dental has received field complaints reporting that during application of torque to the abutment, the upper portion of the
Some humidifiers may fail to operate due to potential malfunction of the internal connection between the heated plate and the pr
If Dicom node config. is set to accept, user may unintentionally add new images to an approved exam, under certain conditions
A healthcare facility reported their end-to-end targeting accuracy was out of specification. The position of one of the robotic man
Customers were erroneously provided with version 0719H0166 of the operator's manual instead of the correct version 0719I016
Excessive heating of the tip of the fixation screws with the standard non-insulated posts may cause minor burning of the contact
This action is being conducted because these components are labelled with a 10 year expiry period when in fact these compone
Several boxes of RET-Search II (Red-700A) manufactured on July 15, 2009 had an incorrect bar code label applied to the produ
There have been reports of revisions of Zimmer's Durom Acetabular Cup and the Metasul LDH (large diameter head) femoral h
Power cords may crack and fail leading to potential risks of electrical shock, delay in setup and therapy, interruption of therapy a
A potential for false positive reactions with some non staphylococcus aureus strains.
The complaints were reported as "run off" (non-contiguous) seals. A run off seal is a seal in which the Angiotech applied seal is
There has been a trend observed in failure of the pole mount clamp shipped with a neoBlue mini LED Phototherapy Systems. W
A software issue was identified in system software 4.2 and 4.2.1, which may result in the incorrect handling of a wash arm dispe
Received two complaints from a customer indicating that the sponge separated at the end during surgery and was left behind.
Two or more treatment plans with different ISOcenter positions are stored together in one course in Lantis, e.g. main treatment
A potential safety hazard associated with the use of Spacelabs Medical 19" Flat Panel Displays, model 94260-19. There is a pos
The table may experience involuntary movement as a result of fluid intrusion. This hazard can arise especially when the table is
Smiths Medical has become aware of an increased trend in reports of "motor not running" ("MNR") and "motor rate error" ("MRE
Bioplex 2200 vasculitis reagent kits could produce false results when analyzing diluted samples.
RTD temperature sensor component was failing prematurely. Temperature control of the sterilization process is maintained thro
When incorrectly used the frame adapter may become damaged which in worst case could make it possible to lock the adapter
Stryker Endoscopy was aware that the SDC HD picture/video capture device would not be able to assign the correct time/date s
The response of the two highest points of the kit's calibration curve are the same and consequently very high D dimer values ma
Advanced Bionics (AB) is notifying all surgeons, clinicians and patients that the removable magnet component of the HiRes 90k
The identified lot number may mechanically seize up, preventing release of the cable tightening mechanism, during surgery or b
A warning letter was sent to the distributor requesting that sales be suspended until a licence has been obtained.
The reagents in wells three (RLC) and four (RLD) of the reagent pack were inadvertently switched during manufacturing. Lot nu
Quality control materials not recovering within predefined ranges. Prothrombin times are prolonged in lot S172057 by about 1.2
Two lot numbers of reagents or strips are allowed to be tested while performing QC testing on the echo. The result is that the fin
Under some circumstances, a manually entered sample ID could be assigned to the wrong sample.
May produce weak positive or false negative results.
As a result of increased viscosity of component "A" in some Kryptonite Bone Cement Kits, the end user may observe difficulty in
Use of CADstream with "pure" software for Dynamic MRI imaging may require a modification to the study preference settings to
Use of CADstream with "pure" software for Dynamic MRI imaging may require a modification to the study preference settings to
Received customer complaints regarding Dimension Vista V-Lyte. Siemens confirms that urine sodium results become elevated
The access 1.0 ml insert cup, used on Unicel DXC Synchron Clinical Systems, might be the cause of some sample wheel motio
Separation of tubing from Distal Clearlink Y-site could occur, which may result in blood loss, infection, interruption of or delay in
1. Female receptacle end: the terminal contact are not sufficiently recessed and protected from access. 2. The cable portion is n
There is a potential that the package pouch in the CBC II Blood Conservation Kits may have a pin hole, a weakened seal, or an
Medtronic Spine LLC is recalling specific lots of Kyphx HV-R bone cement following complaints regarding extended time to reac
A malfunction with one of the components that may result in the overheating of the Oximeter pod has the potential to cause a bu
SRS treatments occurred with conical collimator accessory not inserted, or with conical collimator accessory correctly mounted,
Malfunction when adding CBCT image. Present software has ability to acquire gantry angle when 'treatment approval enforced'
Product may function improperly. This may result in the risk of air bubbles leaking into the infusion system through the BD Q-Syt
The current lot #155166 of TG Gen.2 (Thyroglobulin) Assay shows a premature ageing effect which leads to a positive bias of a
There is a potential for the adapter to crack or break while in use by active amputees.
Consolidated field sequencing (CFS) feature not working properly as X2 jaw moved when only the X1 jaw should have been mo
Precision and open vial stability issues with this lot may result in increased or decreased APTT times across the range of the as
Precision issues with this lot may result in increased APTT times across the range of the assay.
The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The breach of sterility could lead to a c
The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The breach of sterility could lead to a c
The ground wire of the supply transformer exhibited signs of high resistance in a complaint and may give high eddy currents.
The expiration date of the sterile pouched guidewire was not considered when expiration dating was calculated for the finished d
If the swivel locking mechanism is not completely engaged into position, during patient transfer, the table may unintentionally sw
The Vitrax II product is being recalled because during routine stability testing, it was discovered that a sample tested at the three
The TECNIS 1-Piece Intraocular Lenses (IOLS) are being recalled because the haptics of some TECNIS 1-Piece IOLS (model
Review of test records indicated that the seven impacted Powerhart G3 AEDS manufactured by Cardiac Science Corporation (C
The master carton and the individual dressing packages are labelled correctly, however the boxes that contain the individual dre
Compact discs received for EZManager Max Diabetes Management Software packages were identified as being blank when us
Expired OneTouch SureStep Test Strips (lot#274789) were shipped to four Canadian wholesalers.
Incorrect Zimmer implant data in Brainlab Software Knee leads to incorrect information for Zimmer Innex implants.
Customer complaints regarding Dimension Vista Amon method. Siemens has confirmed a negative bias of up to 35% for level 1
The potential hazard of fingers or hands getting caught exists when the patient holds on to the tomographic rod between the col
Decrease of medium selectivity for methicillin-sensitive Saphyloccus aureus strains before medium‟s expiration date.
Error limited to the Rapid Yeast Plus Database regarding differentiation of C. albicans from C. dubliniensis potentially leading to
It was observed that a too short cut of the adapter cannula combined together with certain conditions of stress may have a effec
In ultrasound systems using the Ultrasound Convex Transducer PVT-681MV, the volume image acquired in 'plane C' is reverse
Fault in the brake system may result in gantry-overhead dropping quickly when the overhead is lowered. i-CAT classic containin
Three manufacturing lots of Twist Drill 1.1 x 50mm, 3.5mm stop with J notch, part number 01-7141 were packaged and distribut
Biosense Webster, Inc. has recently become aware of a potential hazard that may occur during the operation of the bloom DTU
i-CAT classic units containing mechanical brake or containing dual brake system- fault in brake system may result in the gantry-
Biosite, Inc. initiates notice of correction for Triage Tox Drug Screen Kit, PN 94400. Boxes shipped after August 6, 2008 are mis
The instrument may generate a negative well interpretation for capture-R ready-screen or capture-R ready-ID assays and subse
The width of the defective Talar Cutting Guides is too large, thus the medio-lateral cuts are too large compared to the Talar trial
Potential for the male swab to present a defectiveness where the cotton head of the swab may dislodge and/or unravel with min
BD has determined that a small number of unit packages may have open seals which can adversely impact product package int
Siemens Healthcare Diagnostics received customer complaints regarding QC isolates when tested on the walkaway instrument.
Customer complaints regarding incorrect high APTT values that may be observed on heparin and heparin-free samples treated
Notifying users in Canada of updating cleaning instructions for the IW900 series infant radiant warmers. The inclusion of the rec
A healthcare facility reported their end-to-end targeting accuracy was out of specification. The position of one of the robotic man
Blue connector proximal to Tuohy-Borst hemostasis valve may fatigue, crack or separate, resulting in patency failure & potential
Enhanced labelling to prevent end of service (EOS) warning messages & reduced battery life resulting from electromagnetic ind
An Arena instrument set to deliver 50 ml/min. may deliver between 40 & 60 ml/min., contrary to operator and service manuals. S
HSA used to produce this reagent does not comply with the USP monograph as per what the current labelling and package inse
Box numbers 1491 and 1534 of this device from lot # P083221C have suboptimal pouch seals. If a cartridge or suboptimal pouc
The LCT-1000 Deep Tissue Laser Therapy is an unlicenced medical device.
Manufacturer has determined that specific lots have shown decreased specificity for negative populations. The positive bias of a
When configured for AEC, after first exposure terminates, subsequent exposures fail to terminate because functionality of ion ch
Composition of electrolyte solution in membrane units for the affected lot 177 are incorrect and cause the sensitivity of chloride
There is a decrease in the measurement of PAPP-A levels compared to previous lots, leading to the possibility of an increased f
Due to an error, some product was shipped out with a new polyamide sleeve material before the qualifying process was comple
This action is being conducted because these components are labelled with a ten year expiry period when in fact these compon
Phadia AB, (Sweden) voluntarily recallsImmunoCAP Specific IGE Control (art.no 10-949-01) containing vial lot BNMAX, BNMAY, or BNMAZ
Handle body may crack or fracture, which could puncture or rupture the skin of the patient, surgeon or attending nurse and lead
Impression Coping Closed Tray NobelActive Internal Regular Platform (RP) 05x9mm (article no. 34235, lot no. 687218) was inc
It is possible for the identified devices to emit smoke from the blower box assembly. Hazard of smoke inhalation and presence o
Use of the current available version of the 10ml diluent syringe, part number (p/n) 9212368 (without spacer), on a Cell-Dyn 1700
Received a report of damage to the distal shaft of the catheter. While the issue should be detected during the preparation of the
Previous results retrieved from the specimen management database, which may be used by rules, may not be the most recent p
Customer complaints received regarding inaccurate results with Dimension Vista Bun Flex Reagent Cartridge in that test results
Potential risk of interference when using BrainLAB M3 on a Varian Linear Accelerator with the Internal Varian Multileaf Collimato
The older version of the device has a design defect which allows for a fatigue related failure. There are two screws that attach th
In rare cases, the target image cannot be displayed or output to an external device after the system is simultaneously operated f
OCD has received complaints from customers reporting that caps on several reagent red blood cell product vials are too tight. In
Review of test records indicated that the two impacted TM55 Stress Treadmills may not have received adequate testing prior to
A small percentage of the devices (approximately 1%) may deliver less than the intended amount of ultrasound. This reduction i
There is potential for the Fowlers (backrests) to drift down to the flat position on the beds. The cause of the drifting Fowler is the
During post-sterilization inspection of the outer blister of the affected lots, it was determined that the outer blister did not meet th
The fuse holder on the transformers assembled on the bottom of a number of Olympus WM Series Mobile Workstations (WM-N
A limited number of complaints have been received regarding the Carendo related to skin pinching. If the Carendo is not used in
A multi-sipping issue was found in BD MultiSET Software Version 3.0.1. The software is not adjusting its acquisition criteria for s
Smith & Nephew has received complaints of lugs missing from the femorals. The missing lugs are apparent to the user upon opening of the
Some units in these lots may contain a void in the side seals of the Tyvek/poly pouch.
Due to a geometrical incompatibility between the light guide cable and light source the "high intensity mode" cannot be switched
Abbott has observed an increase in complaints for the following error codes when using ARCHITECT Total β-hCG Reagent wit
The engraving on the plastic cap does not match the outer label indications for size. The BHR Acetabular Cup and femoral head
The Trident Acetabular System surgical protocol (LSP55) needs to be modified to create separate and distinct surgical protocols
Advanced Bionics (AB) is notifying implant surgeons about the removable magnet component of the HiRes 90K Cochlear Impla
While running the AmpliLink software, there are possibilities (under certain circumstances) that an assay is being performed with
Default configuration may have been modified so that rejected images are included in the retrieved exam, resulting in those ima
The catheters have a deformity in the lumen at the catheter juncture hub which can cause difficulty in passing the spring wire gu
There is a potential that a single lancet may miss the protective cap in the Accu-Chek Softclix Lancet boxes and in the bags in b
A breakage of the pushbuggy handle has been occurring at a calculated weight of 65 kg.
Seven lots of Stromatolyser-IM (SIM-220A) manufactured between March 3,2009 and March 26th,2009 have tested positive for
Under certain circumstances, after opening and closing a study on a CMS system while a study is still open on an in-room NX s
The power supply have short circuited at the electrical outlet upon initial use of the power supply, causing the circuit breaker for
1) In versions 1.1 and 1.1, the needle guide feature was to be disabled for all transducers but actually activated for 1215 transdu
The plastic cap on valve may detach from valve body breaking the vacuum and allowing the prosthesis to loosen or completely d
1. When P3T cardiac protocols are programmed with saline test inject and used in conjunction with ISI 700 or ISI 800 products and the Stella
Stryker has become aware that the third party supplier, for material used to manufacture the Cancellous Bone Screws and Gap
The third party supplier, for material used to manufacture the Restoration Modular Components, has demonstrated poor proces
Approximately 2% of infusion sets in the affected lots (lots starting with 8) may not allow the insulin pump to vent properly. Ventin
Partial or complete detachment of the '903' paper from the demographic portion of the '903' newborn screening card may occur,
Possibility that choice of patient will be changed when using filtered work lists. Normally problem detected because the "active" n
Potential for intermittent or unpredictable circuit board failures due to insufficient copper plating resulting in loss of communicatio
X-ray leakage from diagnostic source (tube + collimator) exceeded 21CFR regulatory requirement and IEC standard. Concerns
Large number of time change requests between two or more CARESCAPE devices may result in sluggishness of CIC Pro, loss
There is potential for data to be lost during reconstruction of images in which slices can either be disregarded or interleaved bas
The possibility of part number 62-5442 2.0 Compression l Plate, 6 Holes Left package may have contained a similar part 62-544
Specific lots of prepared plated media may be experiencing random fungal contamination.
A notification was sent to the distributor informing them that the medical devices that were sold to them by Body Health S.A. wer
Label clarification.
As the Synchron RF Rreagent ages, it may fail calibration with the condition of "math error" on the calibration report. Real time te
When using CT Perfusion 4 algorithm on data with longer time sampling intervals, under certain conditions, the noise level in the
Complaints of particulate matter in the indicator cells, positive and negative control components of the test kit. An investigation h
The Broselow/Hinkle Intraosseus Module, which is part of the Broselow/Hinkle Pediatric Emergency System, contains a 15g intr
Two parts of the tubular packaging could become loose under the shrink wrap that holds the directions for use insert on the pac
Damon SS Archwire 227-1029, 26 mm, mislabeled as 227-1043, 40 mm.
Reduced battery performance (estimated at 2.1% of affected population) has resulted in 8 occurrences of low battery reset betw
The manufacturer identified a reduction of the on board stability from 42 days to 14 days for the Hitachi Tina-quant Apolipoprote
Trinity Biotech initiates a corrective field action for TriniCAL Reference Plasma, product code T5102 (lots R332037, R332037R a
Precision and open vial stability issues with this lot may result in increased or decreased aPTT times across the range of the ass
Precision issues with this lot may result in increased aPTT times across the range of the assay.
The negative control shows an elevated signal. It can exceed the upper quality control limit of 0.200 OD given in the directions fo
The unit package seals on the BD 60 ml Luer lock syringes, a component of the Cardinal Health custom sterile packs may have
On Clinacs running C- series version 7.X, the couch can be moved via the float mode when the stereotactic motion disable func
Biosite, Inc. initiates notice of correction for Triage TOX Drug Screen Kit, PN 94400. Boxes shipped after August 6, 2008 are mi
Abbott Clinical Chemistry Total Bilirubin (6L45) demonstrated under-recovery on one clinical neonatal specimen resulting in a va
If the radius drive assembly on the detectors of Brightview Gamma Cameras is severely compromised, the detector may slide, u
The nonconforming devices were comingled during the manufacturing process. For lot KNRU, there are devices in unit boxes w
Operator manual does not contain description of a re-sterilization process for reusable biopsy metal needle guides for the stereo
Various forms of system lockup or display screen "freezes" can occur. Surgical monitoring has a remote probability that a lockup
Proper validation was not performed on using the headset in an inverted (upside down) manner as described in the noted system
MIS Diamond Burs have the potential to deform and fracture at speeds above 50,000 rpm.
A site reported that their End-to-End targeting accuracy was out of specification. The position of one of the robotic manipulator a
There is a variation in the SmartMonitor 2 manufacturing process that could allow the wire harness attached to the alarm to be p
3 occurrences of catheters containing a piece of PTFE beading material in the OTW lumen have been reported. The PTFE bea
Inaccurate results reported to the system when a sample is diluted and placed back into the system without assigning the samp
Manufacturer has determined that specific lots have shown decreased specificity for negative populations. The positive bias of a
Possible failure of the factor V Leiden control template (positive control) included in the factor V Leiden Kit for use with the LightC
Upgrades initiated to avoid potential problems: pinch points and binding of release mechanism on headrest adaptors, floorlock r
If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, th
Table lock safety features are not always being utilized by the users and have resulted in unintended lateral movement that may
Stryker has become aware that the third party supplier, for material used to manufacture the Cancellous Bone Screws and Gap
Speakers in VSM300 Vital-Signs Monitor failed to produce sound. The failure of the speaker eliminates audio alarm tones for pa
The markings on the gauge are incorrect. The discrepancy may not be apparent to the user and could result in incorrect placem
1) Occluded tubing may cause medication not to be delivered. 2) Misprogrammed infusion caused by ignoring the warning mess
A potential power supply failure inside the GE equipment cabinet could occur with no warning & prevent x-ray generation & imag
Potential video splitter failure inside GE equipment cabinet could occur with no warning & prevent x-ray image display. System c
The third party who supplies Delta Ceramic Ball Heads did not comply with its specifications. The spherical diameter feature was
Some humidifiers may fail to operate due to a potential malfunction of the internal connection between the heater plate and the c
Active Cortisol Elisa Kits will result in falsely high values for patient samples due to a shift in the calibration of the assigned stand
Contrast-enhanced 3D TOF MRA peripheral run-off studies show significant vasculature shading and right/left asymmetry, which
There is the potential for the catheter to break. Additionally there is the potential for the pain-pump to under-infuse pain medicati
A customer has reported that pieces of tissue remained within a Smith & Nephew shaver motor drive unit (hand piece) after the
A healthcare facility reported their end-to-end targeting accuracy was out of specification. The position of one of the robotic man
Manufacturer has identified a defect, a rough square finish to the scissor tips rather than a smooth tip, could cause damage to th
Microbial contamination of Anti-Cardiolipin IGM positive control (lot CPM-591). Calibrator 3, lot CLM3-156, may also be affected
The wash concentrate tube assembly may fail to deliver the appropriate amount of wash concentrate on some Synchron DXC s
This action is being conducted because the potential exists for residual buffing compound to be present on the surfaces of the fe
A potential for false positive reactions with some strains of staphylococcus epidermidis which may result in misidentification as t
48 complaints reporting that the monitors lost power unexpectedly or when they attempted to power up which resulted in loss of
Potential of false positive reactions (blue agglutination) for salmonella E or G serogroups with reagent # 2 included in the kits.
May produce weak positive or false negative results.
An error code (code 13) is displayed on some of the consoles when a stylus or EHS hand piece is connected to the integrated p
The Lasertek 5000 has been classified as a class II device in Canada. This device is not currently licenced for use in Canada.
In a specific case, the TDWorkstation sends the total protein result to the instrument for a wrong patient. Software defect 24578
The cleaning procedure as recommended in the instrument's manual can lead to falsely elevated PT/INR results. This procedur
Reduction on the measuring range from 7-100 u/ml to 7-500 u/ml for the product Anti-CCP Reagent Kit.
It has come to the attention of Teleflex that the tether attaching to the double swivel cap may partially or completely break at the
In certain external transport use environments, the mechanical/electrical connection between the pads therapy cable (including p
The manufacturer has determined there is a possibility that the device may not shut off if the ablate button is released.
Manufacturer has determined there is the possibility that the device may not fully retract once it is deployed.
In Aquilion One System, due to the problem of software and other, a part of the image-related information may be abnormal, or
The manufacturer has updated the instructions for use to state "read the result at 3 minutes. Do not interpret the result after 3 m
Penetrating liquids or sprays entering the system may lead to malfunction of the system, resulting in unintentional mo
Higher than usual viscosity of culture oil may lead to difficulty in culturing. Communication issued to affected facilities but no prod
Boston scientific has decided to revise the DFU for all affected products to include more detailed info about sutures separating f
Coloplast became aware of an InterDry AG stability test failure in that a sample submitted for testing contained no silver. Only a
In rare instances, a system diagnostic test using model 250 programming software (v 7.1 and earlier) may report "lead impedan
The combined use of the Synergy Flex-M/Shoulder Coil 1.5T with other coils increases the chance of RF interaction and heating
A customer could not get a CO2 tracing while the anesthesia circuit was in use because the CO2 port on the filter was blocked w
Some units in the affected lot of Magna-FX Cannulated Screw Fixation System cannulated bone screws may not have the hex b
It was discovered during final review of the product 4027, lot 090402 that the wrong product was issued for packaging. A similar
This device ID was included because of the error on device ID #23037. The catalogue # 7021-392 was wrongly listed under dev
The N-DISVENT-02 acts as an interface between the anesthesia machine or ventilator and the patient monitor. Because of inco
In rare instances, a system diagnostic test using model 250 programming software (v 7.1 and earlier) may report "lead impedan
Possibility of thermal injury to patient resulting from fluid leakage at the cervix around the sheath.
During radiation treatment the usual data were not visible on the operator station display, even though the rad on indicators were
Latch bar on centrifuges may have been improperly assembled. May become loose, disabling safety feature which prevents cus
A problem may occur when an order of long duration (those continuing for several days) is discontinued. Due to the configuratio
A recent modification to Pedicap end-tidal co2 detector may result in increased resistance to airflow through Pedicap and may c
After a brief intense fire in a neonatal unit in the United States, an ECRI investigations concluded the stabilet was the ignition so
Letter to inform all customers on how volume flow calculations are calculated on the affected ultrasound systems and that the fo
The metal shim between the jaws may detach during the procedure and fall into the surgical field. It has been reported that the d
Sterile barrier in the packaging may be compromised.
Sterile barrier in the packaging may be compromised.
The possibility that a sufficiently worn/damaged Universal Cable MC5057, when used with various Conmed Linvatec electric han
The foot control cable lacks the shield connection from the cable to the connector body. The lack of shielding may result in radia
Failure to apply and verify an adequate jaw-shaped field size and field position at the linac for the used conical collimator(s) or th
Power cords may crack and fail leading to potential risks of electrical shock. Delay in setup and therapy interruption and fires wh
The glue joint between the glass and the metal can be insufficient on some syringes, which can lead to leaking and possibly to b
Cover caps exhibited visible cracks post sterilization.
Potential to deliver RF energy without depressing the foot switch. If foot switch is not depressed, and the audible sound is heard
Smiths Medical International Ltd. has become aware that certain Portex uncuffed paediatric tracheal tubes were manufactured w
Unexpected positive reactivity with this lot of product. Invalid test result due to unexpected negative reactions with the positive co
The devices were shipped with an incorrect configuration file, disarming the 'flashing red x' and audible alarms when they are po
Some of the bottles had already gelled and were unusable.
A defect in Version 6.0.0 of Stratus OCT instrument and review software, in certain situations reports generated will have incorre
The Access Thyroglobulin Antibody II (THGAB II) assay demonstrates increased low-end imprecision and false positive rate whe
The recovery of the standard has shifted. Standardizaton of the Immuno Protein Calibrator Set has been re-established to IFCC
There is variability in results of Phenobarbital (PHE) Reagent and Drug Calibrator 1. Results may vary from -3% to +17% with di
The system may shut down and not restart due to a manufacturing error in the printed circuit board in the main-cabinet.
Reaction vessels made from specific lots of resin had an increased likelihood of producing error code 1006 and error code 1007
Complaints received regarding substrate l2subx lots 253 and 254, which may affect the performance of the Immulite 2000 and I
Complaint received of a biassed glucose result on a Vitros 5600 Integrated System. Investigation has found that under a very sp
The sidearm tubing may detach from the sheath during use. If this failure occurs, it may result in excessive patient blood loss an
Resmed received a report of a failure of a VS Ventilator in Japan that had resulted in a failure of ventilation at start-up. It occurre
Difficulties in connecting the product hubs with the Y-adaptors and toughy borst connectors. Product out of specs with thread ou
A small number of PFC Sigma Cruciate Retaining Non-Porous size 5 left femoral cemented components within the affected lots
There is the potential for a compromised sterile barrier in the tyvek lid of the primary packaging.
A limited quantity of the CMAX Hand Controls were manufactured without loctite thread locker on the screws that attach the mou
If not properly configured, software will allow patient allergy and precaution data to be overwritten with automatic updates from th
The previous results retrieved from the specimen management database, which may be used by rules, may not be the most rec
Dishes containing a small crack, which may result in the leakage of cell culture media during incubation. This crack is located on the bottom
The frame earth of the supply transformers for the Getinge 9100-series Washer Disinfector have burnt out on one installation in
Repetitive rubbing of the hydraulic hoses against the interior of the stainless steel shroud may result in the rupture of the hydrau
The material thickness of the trays used for packaging the tube sets may not be sufficient to maintain the sterile barrier.
Table locks may not actuate, causing tabletop to unexpectedly float in either of the following axes: 1) lateral axes, 2) bidirectiona
The stem threads on some units in this lot may be nonconforming, preventing the compression nut from engaging on the stem.
The 2.7mm Cortical Screw Self-Tapping package could potentially hold the 4.0mm cancellous screw partially threaded (part num
Some units in this lot may have the inner tyvek peel tab trapped within the outer seal. This configuration could result in delamina
A partial grid switch failure may occur in Allura XPER and Integris systems that may result in a higher x-ray dose than expected.
The alarm and pulse volume indicators are inverted on the label of french language units.
Stored and printed records may contain incorrect information when records containing default patient identifiers (PID) are confirm
Circuit board supplied by 3rd party for MP 100 hardware platform for CIC Pro version 5.1 software may fail and result in potentia
Evidence of mold was found on the leather pieces on the outside of the braces. Product integrity and effectiveness was not affec
If scheduled orders are documented and edited prior to the orders' original schedule time, Carevue Chart Release C.0 (running
A defective behaviour in data transport layer of the network file system (NFS) connection could cause series as marked success
An error in the coding of the 11.1_M4_0818A version of software can result in images being flipped under very limited and speci
Product made with incorrect buckle, potential for failure.
One lot of Erytype S RH Donor Plates contains an error in the labelling on the foil packet. The product is correctly identified, how
Software anomaly leads to a record save fail in the case that a partially treated fraction has zero dose accumulation. If the chan
The affected MR accessory carts may contain magnetic material and can therefore be attracted to the magnet.
This problem affects revision C and D of the software. In rare circumstances, the settings for paper scale type and recorder spe
1. When images are saved or filmed that contain the curved multi_planar reformation section (CMPRS) while using the dental a
During acquisition (fluoro &/or record), an image could become frozen on DL (digital leader acquisition system) live monitor scre
Product fitted with incorrect power cord (220v versus 120v) and not labelled as certified to the Canadian electrical requirement C
There is a possibility that the light bulb protector (clear plastic bulb cover) on the end of the stylet may detach from the stylet.
The 5/16-24 class 3B threads in the Open Back Halo Rings were tapped with the wrong size or worn taps and do not pass the "g
Potential for a result to be released to the host (LIS/laboratory information system) before a post analytical rule (namely car rule)
Becton Dickinson, a supplier of syringes, notified Medtronic that unit package seal integrity (hence sterility) can be adversely affe
Celsus heparin was used during the coating process, manufactured from material that was found to contain the contaminant ov
Cell-Dyn Sapphire 5.0ml hemoglobin reagent syringes were manufactured with a 2.5ml syringe pull instead of the correct 5.0ml
A partial grid-switch failure may occur that may result in a higher x-ray dose than expected.
The product does not have a Health Canada device licence as per section 26 of the MDR. As a result, a recall was issued.
The recall is issued due to reports of burns while using the device. The burns occurred in the area of charging, typically at the ab
The cannulas leak water when inserted and continue to leak when removed. There has been a change in material without Stryk
Siemens Healthcare Diagnostics received customer complaints regarding reaction vessels which are leaking while running HM m
Difficulty retracting the introducer of Tenderflow Pediatric Arterial Cannula.
The Vertier Table was manufactured with bronze bushings at the tilt shaft instead of the validated teflon coated bushings. The b
The company has become aware of a potential for serious patient injury due to excessive wear that may occur to the drive belts
BHM received incident reports describing a failure of the structure of the boom. The weakening of the welded joint due to exces
Short inspiratory times when using Servo Ventilator 300 automode in neonatal and pediatric patient ranges.
Some HDLC3 reagent lots may generate a decrease in control recovery and an invalid calibration due to calibration factor drift.
The importer was selling research use only devices for clinical purposes.
Unlicensed class II medical devices.
Lot APC20i-0006 failed the quarterly dose audit for sterility.
A potential lack of homogeneity between product vials attributed to a defective excipient in the affected lots of products. This can
The barcode label on the Star Archive Plates used with the Cobas S201 system may not be readable by either the Hamilton Sta
Complaint received from a customer indicating that the product was received with an incorrect directions for use in the package
Debris could build up inside of the instrument to the point that it is unusable if it becomes heavily soiled. The instrument is desig
An increased trend in reports of keypad issues occurring during implementation or shortly after being placed in use. Short circuit
The QP2508 hand pendant has experienced a run on condition. The linear actuator motor continues to run until end of its stroke
Biophen Heparin 6 lots contain a substrate reagent (R1) that is harder to dissolve than usually.
Sorin Group Italia received reports of restricted or blocked flow at the outlet of the mini-bypass bag adopted into perfusion tubing
Difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. It was dete
Discovered a short in the foot switch connector. It is possible that delivery of RF energy can begin without depressing the foot sw
Some lots of 12mm thick and 14mm thick provisional devices may have become commingled during manufacturing. Some units
Some of the packaging trays were cracked. This may compromise the sterility barrier. If used, the potential affect to the patient m
The sheath's radiographic tip marker band may become dislodged or detached from the sheath during an interventional procedu
A software code malfunction has been identified in Ximavision / Ximatron digital imaging v7.5.51.6 sp2. This only affects system
Patient images can be mixed up during viewing and printing. Images of one patient might be stored in the folder of another patie
During routine in-house testing a visual discrepancy was found. The visual non-conformance consisted of a scallop feature with
This corrective action is being taken to address power supply failures on some ventilators. The failures are a result of transient p
Investigation showed some reagent lots exhibited a loss in type O sensitivity which could potentially result in a missed detection
Potential for false positive reactions with some strains of staphylococcus epidermidis which may result in misidentification as sta
There was a typo error on the label of the 100 unit shelf carton. The expiry date on this label reads 2013-13 when it should read
Instructions for preparation of the HG 1539 reagent, required if using human blood samples for application to Ransel Kit, RS 50
Millipore confirmed that specific lots of SimulFluor Flu A/B reagent may cross react with respiratory syncytial virus, potentially lea
The phantom used for calibration of the Gendex GXCB-500 Cone Beam 3-D imaging machine is incorrect and can result in prov
The device is registered as a class II, however it has been shipped with an intended use claim that was not approved and which
The screws in the power MGR board may come loose and come into contact with system 1 chassis, causing a short circuit betw
Detector calibration packs from lot number 950413 may calibrate the Bioplex 2200 detector module incorrectly leading to the po
NT-proBNP and Troponine I do not meet the 20 day open vial claim. Package insert have been revised to indicate that NT-proB
No device alarm when pilot line gets disconnected.
Current product is unable to meet performance requirements which may yield false negative prostate specific antigen results at
Lithium polymer battery for the VCG sensor may fail after being physically dropped from a height (i.e.1 metre). The failed battery
When focal zoom is activated and M-mode is on, performance measurements on M-mode trace may not be accurate. When so
There is an accumulation of debris and discolouration on component assemblies of the device, emphasizing the canopy seal are
The ESD grounding squares were incorrectly placed on an AS50 rear case assembly. The conductive copper side instead of the
Preliminary data suggests that the foreign body reaction of concomitant use of some ancillary products with Durepair is more pro
With the implementation of version 1.1.2.28, Immucor discovered when a clot was detected, the probe moved to the rinse statio
A software defect was detected with its cardiology pacs software when exporting a patient's diagnostic images to a CD.
The LCD monitor support may disengage from its arm and fall on the table. Incorrect cable routing may cause the ECG monitor
The power failure alarm generator sporadically emits signal at a high, barely perceptible, frequency. Affects only units in which th
Voids of various size were found in the seal area of a series of blisters processed on a specific heat sealer. They are related to a
The Inhibin A certificate of analysis has the incorrect unit of measure listed as iu/ml. The correct unit of measure is pg/ml.
1) Intermittent failure associated with the function used to store images. 2) Software failure on the function used to send images
Company did not obtain marketing approval before offering vibe machine for sale...product is a device because it is intended for
In certain circumstances, a patient number could be erased and replaced with the patient's hospitalization number. This defect c
Specified lots of sprayed HA stems produced did not meet Stryker's internal material specification for tensile bond strength and
Reactivity of HLA Typing Trays has changed since the products were released. At the time of release, product met the specifica
A customer safety advisory notice was issued to notify customers about important instructions regarding patient safety on the Ar
Battery sensor board was not insulated. Metal objects could fall on the board during servicing of the systems that may result in s
Outer box labelled as a 2.0mm crimp sleeve may contain an alternate label on the inner packaging.
Customs kits manufactured by Source Medical contain titanium clips being recalled by Teleflex Medical.
The device may not conform to Federal regulations for proper beam alignment and overlap requirements in the mag 1 or mag 2
Leaflet fractures, which could cause leakage from the device of gastric contents and feeding solutions.
A low bias between serum and the plasma samples is greater on reagent lot 138 when compared to other lots.
Ventilating in bipap mode with the pressure rise time set to the highest setting and the expiration time being exactly 0.5 seconds
Screws holding the rails on the easy compression system (ECS) assembly were not appropriately tightened and could create a p
The in, out & net fluid totals values will not honour the numeric precision configuration, which will display a whole number, losing
The transducer used for pulmonary gating kit of the CT subsystem relays inaccurate signals in the bellows system.This could re
AW version 4.2, AW Volumeshare (4.3) & AW Volumeshare 2(4.4): the software incorrectly reloads a save state/save tracking &
There was a presence of a dark discolouration of the Floseal material as it was pushed through the sleeve.
The back pressure and inflow check valves may leak.The cassette interface board fails to establish communications with other d
In-house long term testing has indicated the adapter may crack in extreme situations.
Difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. Investigatio
Complaints received for distal tip breakage of the Synfix LR, Low Profile U-Joint Driver with instances of the tips remaining in the
On inserting the accessory, the IL26 accessory insertion interlock indication may disappear from the monitor even if the accesso
The blades appear to have an excessive taper at the tip of the blade and may break during use.
The lithium polymer battery may fail after being physically dropped from a height. Failed battery may momentarily produce a flam
When using PROPELLER T2 FLAIR application on 3T HD systems the surface coil intensity correction image enhancement opt
Dome develops a tear during device stretch & distention with an obturator or the obturator may slip out of the pocket during plac
All vials within the product lot have been printed with the same serial number.
When scrolling through the images of a series, the scrolling appears choppy, hesitates, jumps ahead and is not smooth.
There is potential to have incorrect patient information associated with results on the DxI console and DxI printed reports when t
Reports of charger 1.0 burns have been reported. Burns occurred in the area of charging while using the charger 1.0.
Devices may overheat (that have the active shunt module retrofit) resulting in the appearance of smoke, a burning smell, and an
There is an error in Solutions Software for iPRO (model MMT-7319 version 2.1A) when the program is set to display blood gluco
If the retaining ring inside the column assembly is not inspected and replaced when worn or loose there is the potential for the su
Boston Scientific identified, through internal testing of the product a potential of a breach to the sterile barrier. Specifically, the pa
There is a software code error, which could result in inaccurate calculations and displays of the group peritonitis rate.
When the zoom mode is used for breast imaging, there is a spatial distortion that can be seen on 3D lateral images.
Ground path on the workstation mounting bracket is suspect. Single fault conditions exist that could energize the mounting brac
The pin and clip may fracture during surgery. Affected lots were found to be non-conforming to firm's explicit specifications.
If DDP configured to place current & historical studies in different regions than system default, user may think old study is new o
Loss of monitoring at Solar 8000i for approx. 1-2 minutes as a result of unexpected reset of Solar 8000i monitor. Problem occu
ICentral does not provide audio or visual alarms for: 1) AFIB, VT>2 & PVC(1) when used with ApexPro, 2)VT>2 & PVC(1) when
An investigation revealed that the digital fluidics PC board (PN 450116-002) contains an engineering design flaw (a missing jum
There is a missing thread feature on both components of the device (the anterior and posterior adapters) that would make the u
There is a remote circumstance that could cause a capacitor in the vacuum pump component of the system to overheat and pot
One vigilance case & 2 complaints were received in 2008 in relation to the Philips catheter, 1 eye, female metric thread. The me
A short circuit may lead to a malfunction in the control box.This can result in an uncontrolled movement of the table which canno
Labelling error. Portuguese instructions for preparation indicate to add 12.9g of CM0895 to one litre of water. Correct amount of
Bio-Rad recommends to carefully review the summary report for duplicate tube position numbers or barcode ID within the same
An issue has been identified that in desktop pro release 6.1, 6.2 and 7.0 sites with precise table, there is a possible error (of up
The outer label of the Unisplint rubber bands (part of Maxillofacial Fracture Kit) indicated natural rubber latex while the inner labe
The calibrator kit storage and stability conditions require an update for lots 25 and above. The calibrator response may be lower
A user working in TDHC who launches the "work in progress" function is attributed the rights of another user.
Dual fault failure mode of Engstrom system may occur that can cause patient airway pressures to exceed the user settable PMA
1) Operating manual incorrectly depicts the connection of the filtrate line & filter, for machine operation in the hemofiltration mod
There is potential of the C-clip located near the connection end could fracture or fall off the device and into the wound.
Some units from this lot may not be etched with the item number and lot number on the rim.
The surestart function may not operate normally and the exam plan may be interrupted or the scan start timing of the actual sca
Review of the current surgical technique was initiated relative to canal preparation for the extra-small humeral component. It wa
There is an increase in frequency of drain time errors (3X223, 3X224, 3X225) leading to results not being generated when testin
Product labelled as 9-10mm Ezloc Femoral Fixation "standard length" actually contained "long length".
There was a cross mix between two batches of Triathlon Primary Cemented Baseplates, size 2 and size 4, for the specified lots
There was a cross mix between two batches of Triathlon Primary Cemented Baseplates, size 2 and size 4, for the specified lots
During internal testing, low absorbance values were observed when using kits from this batch. Investigation has shown the cause of the low
During a routine shelf-life aging test, a small number of devices exhibited signs of damaged packaging, which may lead to comp
During a routine shelf-life aging test, a number of devices exhibited signs of damaged packaging, which may lead to compromis
Looped portion of the grasping snare may detach from the crimp and remain in the patient during the guidewire grasping and re
Once individual MLC leaf position edits are made, original MLC aperture is retained. Further edit will snap MLC leaves back to o
Erroneous but credible results may be generated when prism plot results are not updated consistently when exported to spreads
The recall has been initiated due to a failure in the sterilization and the manufacturer is unable to assure the sterility of these pro
Five kit lots of product were incorrectly labelled with a date that extends past their 18 month expiration.
Upward force of the inner sealing ring on the mating surface of the Drager Clic adapter is insufficient to fully open the gas circuit
Cracking of the priming set drip chamber which is pre-attached to the arterial line was reported. Cracking and leaking of the cha
Ethicon is conducting a recall of 21 lots and 19 corresponding product codes of absorbable sutures for which sterility cannot be
There is potential for data to be lost during reconstruction of images in which slices can either be disregarded or interleaved bas
On specific lot numbers of twister combiset bloodlines a twister port may crack and separate, which may result in potential blood
A Legion 20mm x 160mm stem was packaged as a legion 10mm x 160 mm stem on the outer label. / L‟étiquette extérieure sur
A 46mm head was lasered and packaged as a 45mm head.
Damaged batteries, 2 specific sequence of events lead to invalid infusion register state, faults in internal communications of pum
Hinges are cracking/breaking pre-op, intra-op, and post-op causing loss of functionality of the product. Post-op failures have res
The engraving on the product does not meet drawing specifications. / La gravure sur le produit ne répond pas aux spécifications
Slight possibility of malfunction of the KWIKtrak Gate System. If this malfunction occurs, the gate‟s latch may remain open, even
When using the hematology differential pad (HDP) tool, in particular when both mouse and keyboard are used together, it is pos
Re-assignment of set-points and target values for D-Dimer calibrator and control when used in combination with the upcoming n
Some Lifepak CR Plus automated external defibrillators (AED) contain a specific internal flex cable that may be susceptible to fa
A Cobas Amplicor Analyzer Vibration Damper part was used as a replacement part on a Cobas Ampliprep Analyzer instead of th
Some units could be non-functional for panoramic and/or cephalometric PSP scans. / Certains numériseurs peuvent s‟avérer no
Report received in which a user's hands were crushed in the area of the gas struts. / On a signalé le cas d‟un utilisateur dont les
Product not licensed in Canada. B-K medical has decided to conduct a removal of the device due to administrative oversight. / L
A process change may cause the forward cup to slide over the balloon and off the device tube. There was an increase in the nu
.014 Damon Cu Niti Archwire was incorrectly labelled as .016x.022 Cu Niti Archwire. / L'étiquette du fil Damon Copper NiTi .014
Paint that has been applied to repainted shrouds has failed to meet the paint adhesion requirements. As a result, the paint on th
The Intraoperative Calibrator Card has the incorrect lot number in the barcode (the same # as the routine calibrator). This will no
Material appears to stiffen and become difficult to extrude over time. / Avec le temps, le matériau semble se durcir et devenir dif
Reports indicating the hanger bars have been found to involuntarily dislocate due to contact with riding surfaces such as beds, c
One lot of power tubes contained power thread instead. / Un lot de tubes de puissance contient plutôt du fil de puissance.
Some battery caps on Animas 2020 and IR 1200 insulin pumps are not maintaining contact with the pump's battery compartmen
Incorrect study date and time information displayed in the report screen and title, which could lead to a potential patient misdiagn
Following reports of deep brain stimulation (DBS) leads being damaged when the lead cap is used in the implant procedure, Me
Customer safety advisory notice, under certain circumstances, when editing text in a report, it may result in additional phrases n
The circlip may become hyper extended during installation or service or become deformed during use. This may create a rampin
The outer foil pouch on the Lactosorb Plate System package was not properly sealed. / Le sachet extérieur en pellicule d‟alumin
Error in the formula for calculating zinc phenol sulfonate in method AP008 on the data sheet DS008 caused reported results to b
Exposure to the magnetic resonance imaging (MRI) field may result in a delay in the return of proper drug infusion after an MRI.
Potential malfunction and hence a potential hazard to patient when using Syngo imaging application. Eg, studies of the merged
High level disinfection of Pentax 70 series endoscopes with a forward water jet in the ASP automatic endoscope reprocessor ma
The external chargers used with the vista negative pressure wound therapy pumps are failing to properly charge the pump's bat
Totak Bilirubin Reagents which used the value assignment process determined as a corrective action from FA10AUG2007 caus
Exposed wiring, caused by friction during operation, of the pneumatic unit cable could potentially cause the pump housing area
Product labelled as 3-0 black mono nylon released to the field will contain a 4-0 black braided silk suture. / Le produit étiqueté co
False negative results for the EDDP (methadone metabolite) component of the test. / On a signalé des résultats faussement né
The affected lot was manufactured with water at 23C, which was above the specified upper temperature limit of 22C. The requir
The solid waste chute (DiTi slide, 04J72-29), shipped with the M2000SP instrument or as a replacement part may have sharp e
Sale of an unlicenced class II medical device./ On a signalé la vente d‟un dispositif médical non breveté appartenant à la classe
The centre conductor of the RG316 cable was found to be ferrous and therefore magnetic instead of copper-based material. Th
In software the treatment plans involving very small structure (volume <2cc) residing in a high dose gradient region may exhibit
False negative results for the EDDP (methadone metabolite) component of the test. / On a signalé des résultats faussement né
Safety advisor letter informing customers that the scan protocol "coronaryctaseq" is not synchronized with the patient ECG whic
The following statement in IFU is incorrect: locking straps may be used in combination with synthetic leather cuffs to create a wa
System processors containing a computer worm (networm.win32.padobot.m) it may increase network traffic. / Un virus informat
Rack layout data for non-gyn application PGM (v2.8) are incorrectly reset when gyn software v1.2 or v1.3.0.1 are installed after n
Issue1: Occasional generator software errors may cause light X-ray images with reported mAs readings higher than was actuall
Power supply may fail to charge batteries due to various hardware malfunctions. / Le bloc d‟alimentation peut échouer à recharg
Level sensor not coupling properly to the surface of a venous reservoir due to a slight concavity on the sensor's surface. / Le dé
Certain lots of BD Sterile Trypticase Soy Agar may exhibit reduced or no growth of Candida albicans ATCC 10231 at 20-25 deg
Kits may contain B+A- control agent, incorrectly labelled as A+B- control reagent. Although label is incorrect, bottle contains corr
The Ferno model 35-X PROFlexx legs could experience metal fatigue and possibly fracture after one to 2 years of use based o
Investigational device, HeartMate II system controller percutaneous lead requires replacement to prevent separation of bend rel
Falsely elevated results with Enzymatic Creatinine Flexr Reagent Cartridge. / La cartouche de réactif créatinine enzymatique Fle
Personnel observed discolouration along the strands of the braided cable. Further evaluation and test results identified the disco
Interference due to high levels of salicylate on the chloride sensor. The interference is not detectable initially but increases durin
Access and Access 2 platforms running the total BHCG assay with revised APF (implemented April 2007) may generate erroneo
                                          2-release of a new heparin syringe carrier hardware

1-release of the new software version 3.20
                                                  3-release of a new operation's m
Two Tibial Baseplates size 3 were mispackaged as size 4. One unit has been found, one remains in the field. / L‟emballage de
Update to software version VE31 / 2008C to introduce quality improvements for Dual Energy (bone removal, virtual contrast) as
Rotary knob functionality may be compromised resulting in stack up issues with the components. The risk associated with this e
There is potential for the handpieces to continually run even when the trigger is not depressed. / Il existe un risque pour que les
One lot (170432) of simile composite material labelled A2 was packaged with similar incisal clear material. / Un lot (170432) de
Upgrade of software to version SW 3.35 in order to improve the reliability and safety of the Phoenix system. / Mise à jour du log
Detachment of the cross-piece. The initial cause of this failure is the contamination of the raw material of the pivot shaft which re
During intra-operative assembly users have reported difficulty in fully seating the cup into humeral stem, due to entrapment of a
One lot of Portex Blue Line Ultra Tracheostomy Kits (labelled 15mm connector fenestrated soft seal 7.0mm) was packed with pl
A printed circuit board component used in the device may cause the ablation catheter icon to shift on the map viewer when RF e
When Synchron liquid comprehensive chemistry control is used with the Synchron Cholinesterase Reagent failures of the contro
The filter provided cannot be attached to the Halo 360 Ablation Catheter or the Halo 360 Sizing Balloon. A lot of the filters had a
Safety relevant update of the multifunctional joystick on the remote control console. Conceivable that in case of an intended joys
Software configuration of the 2490C may affect certain wireless Optivol Carealert and Carelink transmissions in patients implant
Some boxes of Vitros Chemistry Products Calibrator Kit 10, lot 0198 that were shipped between August 8, 2008 and October 16
Bio-Rad recommends to carefully review the summary report for duplicate tube position numbers or barcode ids within the same
RT240 & RT340 adult breathing circuit kits manufactured on or before June 27, 2008 include a heated breathing circuit that may
Detachment of the cross piece of the lever on the ground of model Maxi 500. The spring pin preventing the loosening of the pivo
Antibody kit may record false positives. / Les trousses d‟anticorps peuvent produire des résultats faussement positifs.
A possibility for the protective plastic cap over the CT gantry power switch on the line connection box to come loose exposing th
The expiration date on the outside of the kits is later than the expiration date printed on the lubricating jelly packets inside the kit
Potential risk of femur fractures related to per cutaneous pin placement during navigated knee surgery. / Risque de fractures du
Premature failure of the upper peristaltic pump. The pump assembly may not maintain a proper flow rate. / Panne prématurée d
Smiths Medical International has become aware that some needles contained within certain lots of Wallace Oocyte Recovery Se
There may be circumstances where the brake holding force on these beds may deteriorate over time. Potential for patient falls o
The integrity of the bag for enclosure of the remote control for use in the sterile field may not be sufficient to prevent tearing or o
Investigational device, Heartmate II percutaneous lead requires repair kit/replacement to prevent separation of bend relief from
Oral fluid positive control, oral fluid negative control and oral fluid cutoff calibrator were confirmed to have out of specification (O
In the calibration panel, it is possible for "superuser" and "field service engineer" user types to disable the front and back jaw pot
Our supplier Oscor Inc has experienced some difficulties with the insertion of pacing lead connectors into the pacemaker heade
The expiration date printed on the outside product labels is later than the expiration date printed on the Sali-wipes included in the
Potential for a bond failure at the tapered portion of the stent which could lead to stent separation. / Risque d'adhésion déficiente
Immucor has had complaints of unexpected colour, due to microbial contamination, with the reagent red cell component of the l
When DST-XL nuclear gamma camera arm or gantry rotation motion is not in balanced position & the motor's encoder signal is
A manufacturing fault with the printed circuit board in the foot switch. If the couch is left plugged in when not in use, can cause th
An anomaly in the echo software, that can intermittently result in a pause in assay processing on the Galileo Echo instrument, p
Roller pumps failed to power up or experienced unplanned pump stop due to supplier workmanship issues affecting an internal
Roller pumps exhibited jerky operation, displayed overspeed and underspeed errors, and in some cases resulted in pump stopp
Malfunctions on roller pumps and centrifugal control module include distorted display, difficulty to turn speed knob and loss of lo
Immucor has had complaints of hemolysis of some vials of lot 236036 of WB Corqc. An investigation has confirmed microbial co
A software bug in the system that would in certain circumstances prevent certain images from being displayed with no warning o
"Customized" infusion limits (pre-programmed at the Curlin factory as per customer order) are "lost" after pump recovers from e
Devices have been assembled with screws that are not of proper length. The screws are too short which may cause the table m
Devices may have a software defect that may not allow the patient bed exit alarm or the patient movement alarm to function cor
Based on an internal investigation, OCD has updated the calibrator values for in Vitros Chemistry Products Prot Slides. Users ar
Certain Liko Uno patient lifts are being recalled because the actuator of the lift has the potential to separate when the upper arm
Architect C16000 systems integrated to an APS does not consistently generate LAS error 19. Patient results may be impacted d
The Accutni QC label (A31022A) has the incorrect unit of measure listed as pg/ml. The correct unit is ng/ml. The mislabelling do
Reagent well RLB fill volume listed as 4.9 ml. Fill volume should be 4.09 ml. Reagent fill volume information as displayed is not r
The Axsos screwdriver and torque limiter demonstrate the risk of breakage at the tip of the instrument. / La pointe du tournevis e
Customers were erroneously provided with version 0719H0166 of the operator's manual instead of the correct version 0719I016
If a test with a known result is inserted in a patient request via a connection or manually via ERM, and this test contains a rule...
Architect c16000 systems integrated to an APS does not consistently generate LAS error 19. Patient results may be impacted d
Wear of percutaneous lead connecting Heartmate II Blood Pump with external system controller may interrupt pump function re
Specific models and lots are being recalled due to a potential leak at the balloon catheter junction lumen. The leak may contribu
A contact issue between the U25 IC and its socket may cause a communication error upon power up (preventing use), when the
The Cobas 6000 Ion Selective Electrode (ISE) unit may exhibit a downward shift in controls and patients sample results due to i
The Pain Pump 2 Blockaid demonstrates a defect in battery contact which causes the power to be lost momentarily. A decrease
Users of these product lots may experience an elevation in the rate of false positivity when compared with previous product lots.
Smiths Medical Canada inadvertently shipped a small quantity of product that was subject to a recall (#36749). These units were
This lot is contaminated. Continued use of this product could result in contamination media. It is possible that growth of this bact
A problem when patient was scanned in a different position other than supine. Saved images over the functionality "save sets C
Excessive jaw motion function issue. / Problème causé par une capacité de mouvement excessive de la mâchoire.
Software defect causes a change to the jaw symmetry in IMRT plans while using Impac's verify and record system, sequencer,
Through a customer complaint investigation, it has been determined that use of the LSI FUS Breakapart Probe may result in an
A customer complaint confirmed that the VP2000 target temperature was exceeded and the temperature display could not track
Possibility of a false indication of resistance to Amoxacillin/Clavulinic Acid. Continued use of this product could lead to false or e
Product may produce a slow time reaction time. This reaction time may be outside that quoted in the IFU. Continued use of DR0
Received reports of elevated body temp in some babies cared for in the Panda Ires or Giraffe Warmers. Some customers have
Kit may exhibit slow , weak reactions. A preliminary check has indicated that all reactions are within product specs.(i.e. a positive
Thermal index cranial (TIC) is not displayed for neohead exam type with the C8-5 transducer. TIC is required to support the alara principle w
A plan containing a sequence of beams with at least one arc treatment beam, if delivery sequence is terminated and the user se
Manufacturer identified that the graft cutting block with scale had the material listed on the label as stainless steel/teflon when it
The investigation showed a small possibility that the connector (female connector) and/or the internal wiring of the battery produ
Device may fail to detect when an injection takes place without hydrogen peroxide having been transferred to the vaporizer bow
Some HDLC3 reagent lots may generate a decrease in control recovery and an invalid calibration due to calibration factor drift. /
Batch of calibration solution has been allocated an incorrect barcode, resulting in a displaced reference range for accepted calib
The outside packaging for Revolution Formula 2 was mislabeled B2 shade, but syringes inside were labelled and contained A2.
Because of a loose bearing on the pedal of the foot switch, on continued use one or both springs beneath the pedal can fall out
There may be circumstances where the brake holding force may deteriorate over time. / Il peut y avoir des circonstances où la f
The amount of extended bolus displayed as having been delivered, on the pump's home screen 2 and in the bolus summary rep
There is potential for the masks not to initialize therefore the masks cannot be used in surgery. / Il est possible que les masques
Customer complaints received regarding the stability for the Advia Centaur Systems BNP (B-type Natriuretic Peptide) 1, 2, 3 qua
An incorrect technique has been utilized causing the screwdriver top to break off and lodge in the head of the screw. Labelling re
Complaints received regarding stability for the Irma SHBG calibrators and controls, which are not meeting the storage acceptan
Take 1 Advanced Volume FS, dental impression material, was recalled because of complaint that product took too long to set. I
One lot has been incorrectly labelled. Cannula with lot number PFFA211107 labelled as PMF20-100-10CS and should have bee
The high voltage generator may stop working causing a lack of x-ray generation and no image on the display. After rebooting the
Limitation with the process manager system when used with the Hitachi modular instruments. Programmed post analytical rules
The actual scan start time may be delayed in Surestart due to a software problem. / Le moment réel du début du balayage en mode SureSta
In the exam plan for CTA (MA boost) in prospective gating mode, if certain operations are performed, an error occurs due to a p
When device used with flat detector, in specific situations with tensions higher than 115kv, grid may not fully block emission of e
The inner nylon sleeve may protrude from the balloon end of the silicone cannula by 0.57 to 0.76mm and could result in slightly
The CELL-DYN Ruby software system (v 1.0ml and 2.0ml) does not meet the percent carryover claim published in the CELL-Dy
The packaging and the liner were labelled as 32 mm, but the 32 mm liner does not fit with the 32 mm head. The actual ID of the
Complaints received regarding failed calibration and results for the Ferritin Flex Reagent Cartridge, of the Dimension Vista Syste
Complaints received regarding stability for the Irma SHBG calibrators and controls, which are not meeting the storage acceptan
The metallic tip detached from the shaft of one device (P/N AG5514, lot# 6120480) during use. / L‟extrémité métallique s'est dét
Isolates of shigella sonnei were identified as escherichia hermanii by Vitek 2 GN card. These strains of shigella sonnei are unus
When performing digital rotational angiography (DRA) runs, intermittently the geometry software may crash. No movements of s
A partial grid-switch failure may occur that may result in a higher x-ray dose than expected. The potential failure can lead to a ra
Changes to the cleaning and sterilization methods for external sterilizable defibrillation paddles and pediatric paddle attachment
Micro-cracks forming in the metal centrifuge buckets used in the accelerator automated processing system (APS) centrifuge mo
A partial grid-switch failure may occur that may result in a higher x-ray dose than expected. / Il peut se produire une défaillance
The kit was sent to clients without instructions for use. The drills 915-3008 or 915-3009 that are contained in the kit are intended
The protective yellow balloon sheath of the 4.5mm diameter device has been tight. If unnoticed by the user, there is potential to
Use of these particular mattresses in combination with Invacare beds and bed rails may put users at increased risk of entrapme
A leak between the tube interface and the outlet tube of the transducer of the bellows system may result in a failure to produce r
XIO is supposed to recalculate the dose distribution for a port shape but under a particular series of steps a port may be change
Complaints from customers indicated that freshly prepared controls recover within range but drift high the next day and eventua
Several lots (one in Canada) of the DLP Pericardial/Intracardiac Sump Cannulae are being recalled because the sump tip assem
Obsolete pumps with system may have been removed and electrical cables left if cables not removed contact with starter fluid o
The stainless steel tips on the affected devices (hook probe, right angle probe, needle probe) are degrading, causing the release
The manufacturer identified a number of translation discrepancies between the french ezManager Plus Software and the user g
There may be circumstances where the brake holding force may deteriorate over time. / Il peut y avoir des circonstances où la f
The touchscreen on the footboard has displayed a "tilt over range" error resulting in a precautionary safety stop of the bed motio
The hold button used to interrupt an intended patient turn intermittently functions. This may result in a caregiver being unable to
Customer complaints were received showing a slightly increased frequency of positive results in the close cut-off range, therefor
Eclipse SW labelling omitted effect of upgrades on preserving of user selected values for orienting siemens wedges, wedge limi
SW errors between Impac Multi-Access or Mosaic Systems & OBI Versions 1.0.15 & OBI 1.2.05 together with a 3rd party treatm
The default card rules for Vitek 2 systems included with Observa do not address all of the Vitek 2 antimicrobial susceptibility limi
Cap on the reservoir of the device can become disconnected, which could lead to blood loss. / Le bouchon du réservoir pourrait
Product is contaminated with small amount of heparin contaminant oversulfated chondroitin sulfate. There is no impact to device
Product not strong enough for intended use under certain circumstances. / Dans certaines situations, le produit n‟est pas assez
The K3 engine file G-pack was incorrectly labelled as K3 engine file VTVT pack. In addition, one enclosed file was laser engrave
Software (SW) error in Aria SW RT chart. Aria Radonc 8.1 needs to validate all MLC fields during the treatment approval of a pl
A malfunction in Varis software, if undetected could result in an under dose of as much as 100%. Commas used instead of dec
If a Ceph AP or Ceph PA view from Galileos 3D volume is generated in Galaxis and printed via Galaxis or Sidexis, the printout s
Potential malfunction after long usage in some 3D camera's. / L'utilisation prolongée peut entraîner une défaillance possible de
The onboard stability for all Elecsys T3 reagent kits has been reduced from 8 weeks to 6 weeks on all instrument platforms. / La
The tube labels have incorrect preprinted information. The incorrect information reads "Z Serum Clot Activator". The information
Source Medical is recalling the Cardinal Sterile Pack due to a component dye line, a Smith Medical product which is being recal
Module may not obtain a NIBP reading on those patients with pressures in the range of 230mm Hg or higher. / Il est possible qu
Cleaning/disinfection/sterilization instructions are inadequate or insufficient. Manufacturer issued an advisory to all customers un
There is a possibility that the light bulb protector (clear plastic bulb cover) on the end of the stylet may detach from the stylet. / Il
The incorrect volume for the Cunjugate Well (RLB) is printed on the access DHEA-S reagent outer kit box label. The reagent does contain th
In a small number of liquid oxygen units containing the generation 4 liquid level contents indicator, moisture in the indicator may
Capture-R ready-screen and ready-ID test wells that are present in a plate frame during process steps, but not used for testing,
Unexpected negative reactions when using strips previously used as balance strips for subsequent testing with capture-R ready
Power supply unit for the assembly that controls X-ray exposure may fail because it is repeatedly subjected to the centrifugal for
The separation rate of the cannula to the deployment slide of the handle assembly of the device is higher than anticipated. The p
Amphetamines reagent kits lot 15606300 for use on Roche Hitachi and Cobas C analyzers has a greater apparent cross-reactiv
The double-sided product insert for the 45 units was printed single-sided. The product insert provided in 45 kits was not comple
Medications that have an inactive status are not reflected throughout the system in: care maps, dialysis session screens, pre-tre
Contour finding may be very poor, if the image is calibrated with the wrong size of catheter, this wrong calibration could lead to a
Fingers could be caught in pinch points (eg. Under the couch, the rail) while using or moving the exact couch. This can cause in
Calibration of access HAV AB has shifted over time resulting in 20-30% overestimation of patient dose values with the current c
The access FT4 calibration card has the incorrect expiration date embedded in the bar code. The expiration date is printed corr
Safety inspection of Aristos FX tube and detector arm. A visual inspection should be performed to locate any potentially loose m
A small number of valve pouches in the Attain Kits may have an inconsistent seal or edge channels in the seal, potentially comp
The system will display incorrect mechanical index (MI) and thermal index (TI) values, or might fail to display the indices when it
The system will display incorrect mechanical index (MI) and thermal index (TI) values, or might fail to display the indices when it
Some fully automatic AEDS were misconfigured as semi-automatic AEDS. In this set-up, the responder cannot press the shock
Ophit DVI Extenders (component of the device) do not meet electromagnetic interference (EMI) immunity requirements. As a re
Ferno received corner castings from a former vendor with oversized coneshaped holes, which may allow shank pin to seat impr
Reports regarding weak, open seals on the convenience paks (trays). Condition can adversely impact pak sterility. / On signale
The face of the cutter was machined incorrectly resulting in a concave (curved inward) cutter face rather than convex as designe
False positive results with external giardia control or negative control from Xpect Giardia. / Résultats faussement positifs obtenu
Siemens received complaints regarding inconsistent resistance results when using guidelines rules 12.0 and 13.0 (a component
A long-standing high bias with Progesterone Kits for the device was confirmed. Values are high biassed to various degrees acro
Large holes were detected in the thermoformed tray of certain sterile packaged units meaning the sterile integrity cannot be gua
Micro-cracks forming in the metal centrifuge buckets used in the accelerator automated processing system (APS) Centrifuge Mo
The imprinted calibration value (CV) of 102 on the label is incorrect. The calibrator value (CV) should read 266. Only the semi-q
Fingers could be caught in pinch points (eg. Under the couch, the rail) while using or moving the exact couch. This can cause in
During routine post-release QC testing, this product lot has a tendency to exhibit increasingly higher adjustment slopes accompa
An adverse trend in stability may result in a significant decrease in the adjustment slopes (down to 0.7) and a negative shift in pa
Some defibrillators were manufactured with a specific component that could potentially cause the display to dim and eventually g
There are complaints for stains on tyvek pouch or lid stock. Investigation of the returned complaints determined that the stain is
To advise that service mode is only for use by authorized personnel, and that unauthorized and/or softpot parameter changes pe
The manufacturer was providing its clients with an important safety information reminder. The letter contained information that w
Misbranding - the label reads "for postsurgical use following a urostomy procedure". The label should read "for postsurgical use
The presence of a precipitate in the acid dissociating reagent (R1) may cause an elevated background absorbance. / La présen
Two symbols on the side and end flaps of each IntraStent box are reversed - the symbol for diameter and the symbol for length.
Revised control ranges for some of the analyte /instruments. / Gammes de réglages revues pour certaines des substances à an
2 filter migrations were reported in France. The manufacturer indicates that the migration is likely due to circumstances surroun
A failed capacitor on the reflectometer DSP circuit board within the Vitros 5,1 FS system failed and fell off into the slide waste co
The milling blocks contained within the package may be incorrectly marked as e (enamel) shade, instead of a1 shade. The oute
Selenia software V.3.3.1.1 included a magnification factor which resulted in cad marks not being placed coincident with the iden
Reinforce current instructions for use re: detachment of the capsule from the delivery system, and to provide further instructions
Aggregation has been observed in the contents of some vials. / De l'aggregation a ete observee dans la contenu de certains flac
Both products froze during shipment to Roche Canada. The Cocaine and Gentamicin are sensible to freezing. Below zero the p
Certain catalog numbers and lots of Conmed Linvatec hall surgical blades may have a hole(s) in the corner(s) of the blister pack
Healing abutment does not fully seat onto the restorative platform of the implant leaving a gap between the abutment and the im
The collimator drive chain may break or slip off of its drive track, allowing the collimator to "coast" or rotate freely without motor c
Arc treatment plans containing a dose dynamic MLC for IMRT delivery will not be recognized by the system. As a result, selecte
User error: user confuses (selecting) the wash (F6 key) rather than the wash and disinfect (F8 key). / Erreur de l‟utilisateur : l‟uti
A portion of LOA002, lot# 765291 may have been packaged as LOA003, lot# 765295 and a portion of LOA003, lot# 765295 ma
Monitoring of Vitek's product by Biomerieux detected elevated MIC results. May cause category interpretations to shift towards m
A programming error in PBC 8.1.14 & 8.1.17 causes a wedge accessory added to a field of an irreg plan to be ignored. Such a
There is a risk of fracture at the load cell assembly which might cause the mast/boom assembly to fall. / Il y a un risque de bris d
Some reagent cartridge lots exhibit imprecision that may cause falsely elevated results of up to 0.2 ng/ml have been confirmed b
A touchgard feature has been added to the Elekta Synergy KV source to further enhance the safety features of the Elekta Syner
Occasional failures to detect insufficient solution in the wash 1 reservoir which may impact results. / Incapacités occasionnelles
                                                                                 for
Inadvertent use of "sterile" & "non-reuse" symbols on the directions for use 
 the non-sterile, reusable Phaco needles. / Il y a e
To update doctors re: current post-market incidence of reported 
    inflammatory mass at or near the distal tip of intrathecal cathet
                                                                               may
Tantalum capacitor C5 was installed backwards during assembly, which 
 result in premature failure. Failure may result in im
When the catheter is fully deflected and the variable loop is fully contracted, possible that the catheter mechanism can become
A number of valves are incorrectly sutured to the valve holder system. The 
     error makes separating the valve from the holder at
Interruption of Centrimag System support may occur when using a 
        Valleylab Force FX-C Electrocautery unit. / L‟interruption du
Reference card (GMB-0253-01) which outlines the proposed diagnostic 
         algorithm for suspected Crohn's disease contains an er
Measurements allowed on MPR's (multi planar reconstruction quadrants of 2D images) acquired with a 3D free hand sweep, wh
In response to a recent incident with a mobile MRI system in the USA, this update defines additional safety inspection of all mob
The Conmed Livatec Hall surgical blade component of the Cardinal pack may have holes in the corners of the blister package, t
Due to high vibrations of the environment, the connection of the internal flow sensor (spirolog) cable and connector could loosen
Software error in version 5.02 may lead to incorrect results (false positive or negative). Potential corruption of reagent lot memo
During a retrospective review of packaging stability studies, pinholes were discovered in the primary packaging of some devices
Revision of current software to address excessive fluid removal during ultrafiltration treatment and reduce the likelihood of occur
The package label incorrectly identifies the quantity of parts contained in the package. The packages contained only one part ins
Investigation indicates that the sensitivity of the reagent has decreased and has the potential to generate false negative HCG re
Bio-Rad has observed that the performance of the above mentioned lots could be affected : Troponine T does not meet the 5 da
Update / Mise à jourIncrease in revision rate of implants containing polyethylene components sterilized in gamma irrad
Hook and anchor point system that holds the back rest on the Georg Kramer stretcher is easy to unlock and the back rest falls d
Problem with an internal component causes the device to stop working. In some instances, there may be a burning smell from w
Lack of a scheduled preventive maintenance program may have an impact on the safe use of the equipment during the transfer
The inner pouch label and patient chart label may indicate the wrong product name, Amplatzer Septal instead of Amplatzer PFO
Further to a customer complaint that alleged incorrect scatter labelling within the operator manual. The scatter radiation was con
Product is showing higher than expected number of non-reactive values for low level reactive samples during in-house testing u
Some users may have assumed that the SPO2 Non-Pulsatile and SPO2 No Sensor Technical Alarms were enabled when the S
In the event the meter or battery is dropped on the floor the battery may subsequently overheat, split apart and emit an unpleasa
The sterility seal on some of the wrist stabilization kits pouches may have gaps and/or voids and thereby compromise products
In-house quality monitoring confirmed the linearity of the kit is not meeting the claim of 11.4mmol/l. Further investigation determ
Teal power conditioner component may fail with smoke and/or smouldering. The units are enclosed in a metal container, manuf
When the operator uses the distance or area measurement functions on zoomed and batched saved images from the cardiac v
Manufacturer has observed a pattern of device behaviour in which ERO or EOL is displayed during mid-life (24-48 mo) even tho
A small child's finger was severed while playing around the right hand side of the bed. The child had to voluntarily place finger in
The Epker Osteotomes do not contain the laser etch markings on the working end of the instrument. / Les ostéotomes de marqu
The manufacturer has identified the on-board product stability to be limited to 3 weeks when stored on the Elecsys instruments.
Tyco healthcare-maging solutions division have received reports of failure of the CT9000 ADV suspension system in which the J
The screws which hold the Mavig Powerhead bracket (referred to as the j-blow) on the Optivantage DH become loose. In some
The defectiveness of the card is such that the program may not work. The device could fail to analyse A2 hemoglobins using a p
Five lots of Blood Grouping Reagent Anti-S for indirect antiglobulin tests have been the subject of complaints of weakened react
Manufacturer has determined that a negative bias of up to 20% lower values may be observed in % CDT for the affected lot num
Product code 210711 (lot #3069512) was reported to have a manufacturing assembly issue. This lot was assembled with an inc
A macroscopic filament could dislodge from the assembly and possibly enter the bloodstream during use. / Un filament macrosc
High/low mechanism wherein material used to make component to support upper deck can yield and allow upper deck to collap
The stability claim for bicarbonate in the reconstituted control sera Precinorm U Plus and Precipath U Plus cannot be met. Stabi
Some sterile use packages of graft carrier devices were not sealed prior to sterilization. The seal end of the package (flat pouch
It was identified that an incorrect magnesium CAL 2 calibrator value (CAL 2) was provided for one lot. The value is labelled as 3
Customers who use the Syngo Dynamics cardiac calculation feature to perform certain VTI measurements at the Syngo dynam
Circuit board malfunctions could result in failure of the ventilator to breathe for the patient (vent inop) and/or failure of the ventila
The defect in the power adaptor can cause intermittent loss of contact in the connector and the battery may not charge properly.
Customer safety advisory letter issued to customer sites describing that the door hinges the stationary structure might wear out
The manufacturer has confirmed falsely elevated RCRP results when plasma specimens from EDTA blood collection devices a
A material change was made to the shielding material of the sensor. The change was determined to be a significant change and
Potential for failure of growth of haemophilus influenza. Lack of growth would most likely be evident from growth seen on accom
Information regarding scatter radiation in the manual for the I-Cat machine needs to be corrected. The new values may require t
Firm is recalling custom pack containing a component - Zimmer Hemovac Systems due to pinholes which may potentially be pre
Possible for patient identification numbers and names to be applied to images from another patient due to an issue with the soft
Pinning of the anterior holes potentially causes interference when punching. / L‟insertion des broches dans les trous antérieurs
Consumer reports related to skin irritation and burns surrounding the BD Tensor Heat Therapy products. / On a rapporté des pla
The company identified a component production issue which may cause the cartridge to deploy an incomplete staple line. / La s
Label information incorrectly denotes the length of the coil in mm, however the length should be denoted in cm. Cat number and
Under certain conditions, the system will display incorrect mechanical index (MI) and thermal index (TI) values, or might fail to d
Tube kinking-improper tubing installation may result in serious injury or death. / Une coudure ou une mauvaise installation de la
The manufacturer received customer reports that their Sterrad Sterilizers were emitting a mist due to premature mechanical failu
Sterilization methods described in labelling may be ineffective and may cause damage/corrosion to the internal handles/paddles
The 5 FR (110 cm) temporary pacing catheter / 6 FR introducer kits do not contain a complete / FR introducer assembly. The in
A single lot of Fastpak batteries with a capacity of 1.0 amp/hour was mislabelled by a supplier as part number 3009376-004 NI-C
A touchgard feature has been added to the Elekta Synergy KV source to further enhance the safety features of the Elekta Syner
As a result of a packaging error a small number of units of one lot may have been shipped with either no instructions for use (IF
In Aquillion One CT scanner, the surestart function may not operate normally and a phenomenon in which abnormal analysis res
Section 3.4.2.5.3.5 Cell-Dyn Sapphire numerical result label of the lis/middleware interface specification includes a data table th
A secondary safety switch may not function as expected. In the event that a primary serial changer support band should fail, th
Internal investigations indicate there may be a problem with the performance of this lot. The Elisa plates have been found to yiel
Possible false positive results when using the Advia Centaur HAV IGM assay, which may confuse the picture for diagnosis of he
Level sensor pads detaching from the surface of the venous reservoir. Level sensor pad is a single use device intended to hold
Certain lots of bag sets (8-5101) were not assayed for endotoxins with limulus amebocyte lysate (LAL) as a manufacturing relea
Images generated using the Isite native multi-planar reformation (MPR) feature could be oriented incorrectly if the patient is scan
XIO contains a software bug, that is a discrepancy between the beam weights and dose displayed. When weight is edited, old b
Immucor has had complaints of significant hemolysis or unexpected color with certain lots of Corqc Test System. / Immucor a re
In rare cases the offline mode is not possible to activate as intended for devices with the system version 2.0.9 or lower. / Dans d
Two lots of heparin contaminated with oversulfated chondroitin sulfate were used to manufacture some lots of carmeda-coated
Potential occlusion (partial or total) of the set of the arterial (red) connector to the dialyzer which could pose a risk of hemodialys
A potential format failure may lead to the hard drive in some OEC 9800 devices to fail prematurely and be unable to store image
Increased frequency of certain displayed error messages e.g."on-board QC-out of range-try again" or "sample not seen-turn off-
Certain lots of Cardiac Troponin I (CTNI) Calpaks (CCTNI-CR) may exhibit an age-dependent calibration issue that causes lowe
Some omega tables may experience an unexpected downward drop to its lowest position when adjusting vertical motion, followi
Reported that the SUV tool reports different values (MAX SUV) for a small tumour depending on whether the PET is opened alo
The urethral kit fibres may not illuminate along the entire length of the fibres, which can result in inadequate visibility of the ureth
Measurement errors could occur when using stenosis analysis software. If Innova sense patient contouring is activated on smar
The centre insert of the component could become loose and/or come out of the adaptor housing. If the centre was to become lo
The Conmed electrosurgery needle components of the Cardinal Health custom sterile kits have an inadequate packaging seal. W
Flat panel mis-alignment of the panel which could be up to 4mm. / Le mauvais alignement du panneau horizontal peut atteindre
Problems of sporadic artifacts, sporadic scan aborts, problems with remote downloads and problems with revision of the ETX bo
95% of the time one cell or less may be carried over to a subsequent patient sample slide at a WBC level of approximately 90,0
Unintended motion of tube stand pressing on to patient while they were on the table. Spot film device & tube column move towa
Under some circumstances single images from the other patients or studies are displaced in the viewer in wrong context. In rare
A current switch holder was changed in 2005 and was only available through spare parts, one which was defective it is necessa
The D-Dimer High Control (part number: 1468, lot R194025) does not consistently recover within the assigned range when used
Manually aiding the resumption of processing of unread batch tubes, the instrument causes lysis of prepared daughter tubes, in
Incorrect bottle values for master pools were used to assign four lots of calibrator. This has resulted in an approximately 6-7% lo
The working tips of the Stella Osteotomes are thicker than specification. / Les pointes de travail des ostéotomes Stella étaient p
The maintenance release 2(MR2) implements several fixes that are related to IEC compliance and corrects several other proble
Incorrect label- the label on the back of the device may show model 2500A rather than model 2500 where 'A' indicates the devic
During routine shear valve maintenance there exists the possibility that a scheduled autowash can execute with the shear valve
Drystar Axys production process specifies the default value for film calibration is to be set "on". A number of Axys printers were
An issue has been identified that in desktop pro release 6.1, 6.2 and 7.0 sites with precise table. There is a possible error (up to
The WBC result and the differential may be overestimated and not invalidated with the WBC suspect parameter flag on the cell-
Some values in the parameter sheets for the Advia Chemistry Systems released between October 2007 and March 2008 were i
Recalled pumps contain one of the previous versions of pump application software. As a result users may not be able to program
A limited number of devices were manufactured with a printed circuit board assembly that may cause an intermittent short. If thi
One supplier did not meet material specifications for manufacture. As a result, the device may be more prone to fracture during
Lots manufactured with a prior version of the guidewire lumen material which is not validated with the current manufacturing pro
Field action initiated to resolve a potential condition where a collimator on an x-ray system may become loose and fall from the x
Control set has been reduced from 24 hours to 8 hours at room temperature, from 30 days to 7 days refrigerated and from 3 mo
Three lots of heparin contaminated with over sulfated chondroitin sulfate were used to manufacture some lots of trillium-coated
The software package insert states that certain software disks should be installed in order to perform the Digoxin II assay, howe
If skip forward button used during stage 2 segmentation - system may calculate final dose with the pencil beam algorithm when
An anomaly has been identified with the rpm version 1.7 where a failure can occur that affects the gated radiotherapy treatment
Possible bacterial contamination of burkholderia cepacia present in the mirror clean. / Contamination bactérienne possible du ne
Cardinal health received reports of inaccurate flow rate with the Alaris pump module related to misassembled (missing, bent or b
The calibrators of the ebv igg, ebv igm, syphilis igg and ana screen kits could produce a reduced level of fluorescence. / Les cal
There may a be risk of discrepancy in the identification of samples by bar codes if errors or defects in the device are not correct
The reactivity and performance of the Amplichek Swab ct/gc control, amplified positive (positive control for Neisseria gonorrhoea
The recall is due to a change in the interpretation of the data concerning the interferences during hemolysis or with triglycerides
The results for the lipase tests can be modified (increase) when they are performed after an ldl test. / Les résultats des tests de
The nut located in the bottom part of some models of scales may loosen under certain conditions./ L'écrou localise dans la parti
Minor discrepancies noted in the English version of the user guide for Animas 2020 insulin pump. / Certaines différences mineu
The mask image for the smartmask overlay may not match the live fluoroscopy image if the operator changes with the detector
The operating manual states that increased suction can be accomplished by clock-wise rotation of the regulator "needle", when
The C-arm on the BV Endura (release 2) unexpectedly shuts down during the use of the optional remote control feature. After a
A possibility of damage to the cotter ring on the ram end of the Hi/Lo motor may occur when the bed is in the low position during
A review was conducted and it was discovered that the lot number indicated on the vial and flyer were different from that indicate
BD is concerned that in some instances the safety mechanism of the BD vacutainer cannot be activated. As a consequence, the
Product may exhibit decreased or no reactivity during quality control testing. / Le produit peut manifester une réactivité inférieure
During a fill cycle, if the system is powered down or a power failure occurs, the system may not record the last 1 - 4 pump stroke
Increase in leak complaints when the glass flow restrictor was replaced with a tubing flow restrictor, which could result in skin irr
A failure in manufacturing process which resulted in some masks having small slits under the folds of the mask, thus they may n
Due to a design defect, the 3-way valves may fail, allowing cleaning solution, which contains bleach, to leach into the analytical l
The sterile barrier has been compromised on the electrosurgical pencil electrodes. / La barrière stérile se trouve compromise au
Possibility of no fluid or restricted fluid flow when using cannulas from affected lots. / Risque d‟interruption ou de réduction de la
Reduced concentration of bicarbonate because of leaking vials for nh3/etoh/co2 calibrators and controls (used with cobas integr
Potential increased risk of stem neck fracture when a V40 +16mm offset femoral head is mated with certain accolade TMZF fem
Potential for a leak in the helium drive system. The leak will result in a "helium loss 2" alarm. The loss of patient support would b
Lot may not exhibit the proper biochemical reaction when tested with neisseria meningitidis ATCC 13090. / Il est possible que le
Peel away introducer may not peel uniformly and/or completely. / Il est possible que le système d‟insertion de type Peel-Away ne
The system may incorrectly recognize the couch-top position when the couch-top is set to "free" mode and quickly moved manu
Transilluminator model BF-150 has not been approved or cleared for marketing (considered an unapproved device), and therefo
A defect in the printed circuit board may cause the pump to exhibit intermittent malfunctions, which include failure to start-up or r
Digital electron variable applicator is compliant with IEC60601-2-1 except for radiation leakage at distance of 2cm from the side
The curvature on some implant stems is out of specification to varying degrees causing a discrepancy in the stem curvature bet
Two incidents were reported where the goldbal (detachable balloons) deflated before or during implantation. / Deux incidents on
Some units already have twisted transducer cables, but do not have broken glue seal. There have been no reported injuries ass
Surgeon reported that the back of the Visx Star S4 IR Excimer Laser System patient chair began to rise and would not stop. / Un
Since may 2005 meters were sold with old version of operator manual instead of updated version. Risk of infection and potentia
The device was shipped into Canada prior to filing all of the expected Canadian radio licencing documentation. / Le dispositif a é
In a small percentage of specific kit lots, the hsv common antigen band appears lighter (less reactive) than the reading control b
Movement without command from the operator and unexpected movement if the system is powered down and re-energized afte
The bender is leaving deep dents in the pectus bar. / La pièce servant à plier la table laisse de profondes entailles dans la barre
Zoll E series defibillators with software versions 3.00 and higher may transmit or print incorrect patient records. / Les défibrillateu
The potential to exhibit slow or no deflation, which could result in total occlusion of the vessel and lead to arrhythmia, ventricular
 It was discovered that some cork manufactured non-ha coated trident acetabular cups and some ha coated trident acetabular c
Potential increased risk of stem neck fracture when a V40 +16mm offset femoral head is mated with certain accolade TMZF fem
Removal of endoscopic ligating clip appliers ELC (530). Certain ELC devices that were manufactured between Oct 2005 and Ma
The fused study tomographic includes some mapping discrepancies (points from the 2nd study are not displayed as intended). T
An overflow sure value (OD>4.000) leads to a flag "4.000" which replaces the measured sure value. This flag is forwarded to the
An anomaly has been identified with the RPM version 1.7 where a failure can occur that affects the gated radiotherapy treatmen
The use of toolkit.sh to regenerate the structure of the combined test dictionary (sdive tool) in certain conditions could cause bro
The system may incorrectly recognize the couch-top position when the couch-top is set to "free" mode and quickly moved to ma
In some cases the bolts used to secure the Z mechanism to the ISO-base arm have sheared off, resulting in inability to operate
Inaccurate results with bun flex cartridge lot FC8283. Only a portion of the lot is affected and not all wells within an affected unit.
Breakage: the inner rod of the applier may corrode and break. / Bris : la tige interne de l‟applicateur peut se corroder et briser.
The Vancomycin may on very rare occasion obtain an erroneously low result when running the assay. The QMS Vacomycin is e
Some syringes have been assembled with silicone lubricant applied to the plunger tip and not just the sides of the plunger. The
When the axsym amphetamine/methamphetamine II positive and negative interpretation cut-off (assay 116 and 117) are edited
Precise plan releases 2.00, 2.01, 2.02, 2.03, 2.10 and 2.11 for SGI and 2.15 for Linux generates digitally reconstructed radiogra
Cell-Dyn Sapphire software transfers both accepted and rejected QC records during download of records from the instrument to
Microbiological
contamination
in
some
bottles
of
the
identified
lot
numbers
cause
elevated
WBC
background
during
sample
a
A loss of ventricular sensing would prevent an ICD from being able to detect an arrhythmia. / Une perte de la détection ventricul
One or more of the 4 castors could get loose due to a break in the trolley chassis and could cause injuries. / Au moins l‟une des
The possibility of delivering an unintended bolus if the pump door is opened and then immediately closed following stoppage of
In latest software revision, it has been found that 2 specific programming sequences can lead to temporary de-synchronization b
Three fielded, in-date lots of IMMAGE CRP reagent found to exhibit a prozone or hook effect that begins between 35 and 65 mg
Potential for packaging material degradation that may result in non sterile product. / Une dégradation potentielle de l‟emballage
Autoagglutination and cross-reactivity. Continued use of these lots of Streptex group A may result in misidentification of non-gro
If you use a ")" as a decimal symbol instead of a "." in the windows regional setting, the values to the right of the decimal comma
Improvement of the table movement, control unit and table inserts. / Améliorations des déplacements de la table, de l‟unité de c
Following complaints of weakened reactivity or false negative reactions with some lots, an investigation confirmed decreased po
Allofit shell size 50 (catalogue #4244,lot #2406181) may be packaged with Allofit shell size 52 (catalogue #4245, lot #2407192).
In the 3.5mm ULS instrument and implant case (00-4836-090-00), the artwork for the 1.6mm per cutaneous ULS cannula is inco
There is a potential laser marking error and mix-up of two sizes of Metasul heads, size 44 and size 42. / Une erreur de marquag
Editing the structure properties - color, rendering - in Focal can : 1. Cause the MLC to discard individual leaf edits that do not m
Silicone stains on the tyvek lid stock may affect the sterility barrier of the package and pose an increased risk of infection to pati
Water heater tank is rusting resulting in the in-line 0.2 micron filter prematurely clogging, interface board malfunction resulting in
The conmed electrosurgery blade component of pack may have an inadequate packaging seal. / Il se peut que le sceau de l‟em
The electrode assignment may not be correct on a small number of these devices and may cause misinterpretation of EEG loca
Detection of stringer flash (ribbon-like, metal residual material) during in-process inspection of a product lot. Component when i
Some lots have a lower separation strength for the 90-degree elbow to the pour spout connection. Separation may occur during
The recall is due to a change in the interpretation of the data concerning the interferences during hemolysis or with triglycerides
Increased trend of leakage associated with certain lots. If leak occurs, situations such as spillage of medication, contamination o
Clinical Chemistry Phenytoin does not meet the package insert claim of onboard stability of 28 days and calibration stability of 14
If the battery cap is not fully tightened down or if it is damaged, the pump may power down and brief chirp sound. Delivery of ins
The use of Microalbumin calibrator lot 7HD049 will result in poor calibration and unacceptable recovery of quality control. Quality
Lot 6542849 shows an unexpected high variation which is indicated in most cases by recovery of control plasma N and control p
Following investigation of returned complaints for stains on the tyvek pouch or lid stock, the source was identified as silicone use
Volume data based on acquisition series acquired by other than head first-supine, the resulting slice images show wrong orienta
Separation may occur of the m-style cup from the stem of the vacuum assisted delivery device resulting in loss of vacuum. / La
The master list packaged with Capture-R Ready-ID lot ID098 contains an error for the donor N2397 typing. The donor N2397 typ
There is a potential risk of the batteries in the Kion to over charge. / Il existe un risque potentiel de surcharge des piles pour les
It was noticed that after updating the HCU 30 to 1.00.01 the compressor would not start until 30 minutes after the self test. / On
It was found that 2 derived parameters, added to the latest software version (V1.10), were calculated based on incorrect equatio
Encore became aware that 2 unlicensed units, of cat. Number 400-01-290 were implanted. Other unlicensed units imported but
Beckman coulter determined that 95% of the time one cell or less may be carried over to a subsequent patient sample slide. / La
The stability of bilirubin after thawing the vials is lower than predicted by the accelerated stability tests and Bio-Rad no longer rep
Numbers in the registration fields on printed pages of the registered tab, appear to be different from the operation station display
Concordance error. Mechanical abnormality in the rack caused the rack to advance to position 3 instead of 1 resulting in concor
Avoximeter 1000E instruments may have been sent to customers with the "diagnostic mode" enabled which may lead to potenti
Product name on the label erroneously reads "Perfektum Toomey evacuating syringe" instead of "Popper Interchangeable Hypo
On some units during the sterile cycle while using the C1160 tray, the system 1 processor could fail to abort even if the high pre
A defect in O-Arm Imaging System software version 3.0 causes an error in the displayed position of surgical instruments in the i
PQ-series scanners provide information to the Pinnacle3 RTP software to enable the absolute marking feature of the ACQSIM3
If operator uses the distance or area measurement functions on zoomed and batched saved images from the cardiac or pulmon
Electrical short circuit of device following excessive use of cleaning solution. / Un court-circuit électrique se produit dans le dispo
There is a potential risk of the locking mechanism inadvertently releasing. If the traction boot becomes dislodged during a lower
To install a cover with high voltage warning labels which will increase protection and awareness of a HV power supply. / En vue
The device exhibited characteristics that are inconsistent with the product specifications. In some cases, char and coagulum hav
Some orders and/or interventions do not always appear as expected in the work list feature of the system. However, system ale
Sterility was not determined prior to re-work of products in inventory. The testing performed to demonstrate the adequacy of ster
Due to a molding issue with a component, the device may not provide expected oxygen concentration and/or expected flow rate
The stability of the anti-TG and anti-TPO is lower than expected when the control is analyzed using the Siemens Immulite device
Several complaints of false positive with the Captia Varicella-Zoster virus (VZV) IgM Elisa. / Plusieurs plaintes ont été formulées
A missing door post pin could cause incomplete or no engagement of radial arms into the lock rails of the door when closed. If d
In the USA there were reports of burns and skin irritation. In Canada there have been 4 reports of skin being removed when the
Product has produced false positive reactions for negative specimens and the negative control agent. The false positive results
Increased risk for prosthesis loosening due to gamma irradiation of polyethylene components in air. Following the Health Canad
Capacitors located on the main board may be reverse polarized. An affected monitor may shut down without producing alarm or
There is a issue concerning unintended direction of gantry rotation during an auto-sequenced treatment delivery. / On a observé
As a result of a manufacturing error by the motor component supplier, motor operation in specific pumps may be affected and c
Item #122-242, 4.4mm width increasing drill, was incorrectly substituted for item #122-237, 3.9mm width increasing drill during a
Two conditions may cause the user to unintentionally modify a locked fraction group when using the "beam edit" function to mod
A number of iViewGT 3.4 upgrades have not installed the iViewGTR.3.4 service pack 2 (SP2). / Un certain nombre de mises à j
Sigma 8000/8002 Infusion Pumps are not compatible with the recently redesigned Hospira Cair roller clamp. Customers should
The hoist may continue to move left (or right) after the caregiver releases the left (or right) action button on the infrared remote c
According to the manufacturer, there was an error in the range of the IgM positive control in the QC fact sheet. Problem was ide
An accessory (60 degree wedge) slid out of the interface mount and fell to the floor while the gantry was in motion and the patie
I-Flow discovered the two lots listed above may contain an incorrect fill port label. Full name of device is "ON-Q C- bloc (1-7 ml/
A software code malfunction has been identified in Ximavision / Ximatron digital imaging v7.5.51.6 sp2. This only affects system
The ON-Q PainBuster, PS6504 box may contain ON-Q PainBuster, PS6502. / La boîte contenant des ON Q PainBuster PS6504
Ratchet extender not having proper retention in the mating ratchet. The O-rings used on the ratchet extender may not provide su
Manufacturing
error
has
resulted
in
some
kits
containing
more
than
one
type
of
transfer
pipette.
/
En
raison
d’une
erreur
de

Roller
pump
fails
to
operate
due
to
an
electronic
component
malfunction
on
an
internal
circuit
board.
/
La
pompe
à
galet
ne
f
Risk
for
leakage
has
been
identified
when
the
Phaseal
Protector
or
Injector
are
used
with
drug
vials
with
thick
rubber
stopper
There
is
a
limitation
that
exists
in
Petsyngo
2.X,3.X
and
4.X
software.
Pet
data
may
be
saved
to
the
wrong
patient
registration
Following
the
initiation
of
a
recall
in
June
2007,
replacement
boards
had
been
shipped
and
later
discovered
that
the
boards
h
Inaccurate values for two analytes on the assay certificate. / Valeurs inexactes de deux analytes sur le certificat de dosage.
Cell
9
of
resolve
panel
A,
Lot
RA539
(Expiration
Date
15
August
2006),
which
is
indicated
on
the
antigram
as
being
WR(A+),
is

Product
unlicensed
for
sale
in
Canadian
market.
/
La
vente
de
ce
produit
n’est
pas
autorisée
sur
le
marché
canadien.
Positive
bias
of
approximately
0.1
PH
unit
on
the
Nova
8
analyzer
which
can
cause
higher
than
expected
calculated
normalize
Manufacturer
has
identified
several
issues
concerning
the
software
through
complaints
received
which
are
not
likely
to
impa
Manufacturer
has
determined
that
some
Peep
10
Resusable
Peep
valves
do
not
hold
the
set
peep
level
when
used
in
certain

Product
may
misidentify
a
W135
serogroup
as
a
Y
serogroup
if
the
product
is
used
incorrectly
and
not
per
the
package
insert.
The dimensions and shape of the capillary end caps do fit the capillary tubes correctly potentially causing the capillary tubes to le
Material in bottle may solidify and cannot be dispensed. There are no health risks with using the product because once solidified
Risk for leakage has been identified when the Phaseal Protector and Injector are used with drug vials with thick rubber stoppers
Inform users that a misplacement of the X and/or Y jaws can occur if interlock#51 jaw field position is asserted and then cleared
Application of a service safety warning label - Klystron Filament Power Supply Electrocution Hazard.
/
      Application
d’une
étique
To advise clients that simultaneous activation of motion and collision overide buttons may cause unintended motion (collision ha
Increase in number of confirmed complaints assigned with Luer Lock-tube full or partial separations since early 2005. Failure sta
Complaints were received regarding falsey elevated troponin values yielded by these assays. These falsely elevated results are
The maintenance release implements several fixes that are related to IEC compliance and corrects several other problems. 
/
          L
Manufacturing error has resulted in some kits containing more than one type of transfer pipette.
/
     Une
erreur
de
fabrication
exp
When the Observa system is interfaced to a Laboratory Information Management System (LIS), some error conditions may cau
In late August 2007, Philips received feedback that two of the recently released version C pagewriters were providing inaccurate
Product information letter regarding amount of plasma volumes remaining in the kits after reinfusion and product transfer. This i
Monitors distributed between May 2007 and August 2007 may experience display damage when dropped onto a hard surface, re
An amendment to previous recall for incorrect pouch and pouch labeling combinations to finished product resulting in the omissi
Screws in the implant sets type S40, produced prior to January 1, 2006, may disassemble during surgery. The movable cradle c
Guidewires packaged in the affected kits may be incorrectly loaded in the trigger guidewire dispenser, which results in the stiff ti
Thyroid peroxidase (tpo) antibody (ab) calibrator lots are not meeting shelf life claims of 12 months at 2-8 degrees celsius. / Cer
Access ultrasensitive insulin reagent kit recovers variable dose values with serum samples as compared to plasma samples. / L
Reports of stopped infusing during specific use conditions, the pump issued an audible alarm and visual alert notification, displa
There is the possibility that the vessel cannulae may have leaks in specific lot numbers. The vessel cannulae are found in two s
The movement of the collimators can be induced during multi segment beams such as imrt and omniwedge, which will not be de
A Faulty potentiometer or slider switch located in the xvi detector arm could potentially result in incorrect positioning of the detec
Visual defects of the reaction vessels which can affect the instrument's ability to adequately wash during instrument operation. /
Temperature changes after calibration may cause increased variance in assays performance on unicel dxl 800 instruments that
Occasionally the recovered values for percentage basophils (ba%) is out of the low limit of the expected range. / Il arrive que les
The total imprecision for the myoglobin reagent is less than or equal to 10% and not less than 8% as stated. / La marge d‟erreu
If patient being monitored with st monitoring disabled is in pre-existing condition of continuous message or advisory level alarm
Due to a transcription error, a co2 calibration value as programmed incorrectly into the cal pack barcode. An expanded investiga
Potential for operator's finger to get pinched between the fixed roller and the gliding tabletop. / Le doigt de l‟opérateur pourrait re
Memory chip in these units has a limited number of read/write cycles that will limit the useful life of the device. / La puce mémoir
A batch has been received frozen and is unusable./ Un lot a été reçu congelé et est inutilisable.
When a spectrum of a pulsed wave doppler that shows an angle correction unequal 0 is reloaded from archive or sent to a dicom
Fracture of the spike in the Phaseal Infusion Adapter C100 when used together with certain drugs in combination with certain IV
Voluntarily suspended distribution due to potential for lead fractures. Physicians should no longer implant devices. Physicians pr
When injection parameters are simultaneously programmed at both the main and auxiliary consoles, mis-synchronization may r
Potential for false positive results. / Risque de produire des résultats faussement positifs.
Clinical chemistry ICT calibrator has shown several calibrator sets within the lot to produce depressed but acceptable potassium
Durom Acetabular Component size 54 (catalogue 01.00214.054, lot 2380677) may be packaged with Durom Acetabular Compo
Small number of falsely reactive neonatal cerebrospinal fluid specimens with Wellcogen N Menigitidis B/E Coli K1 latex test reag
BD has determined that if the undo function is used to undo a gate deletion, the statistical results may be mismatched. As this m
The manufacturer has identified three issues: surface temperature (may exceed the set limit), displayed TI (incorrect values are
Freezing an image with the "clip start" function activation may result in a lock-up of the operation panel in Aplio XG model numb
Centrifugal control unit display went blank when the start button was pushed and the pump did not start. / L‟affichage à l‟écran d
There are calibration failures and intermittent, progressively decreasing dose values throughout a pack. / Il y a des défauts de ca
Instrument failed ground continuity testing. / Le dispositif a échoué au test de continuité de la mise à la terre.
Products received from Biomet Microfication are of the incorrect length. / Les produits reçus de la société Biomet Microfixati
Some cartridges may cause decreased quality control and/or patient results, increased imprecision, and error code 1054 on arc
Packaging sterile barrier has been compromised for the Frazier and Poole suction instruments. This is an extension to the recal
Five conditions that, under certain circumstances, may cause results to be associated with the incorrect patient, contamination o
Unitek stainless steel permanent molar crowns (900321) were placed in packaging which incorrectly identified the product as Un
Manufacturer is recalling these devices as a precautionary measure due to a potentially incomplete seal of the product package
This update addresses a problem in the motion control logic of the Flat Panel Positioner (FPP) controller, enforces use-restrictio
Lot may be etched and packaged with a size "G" provisional (catalogue 00-5755-017-02, lot 60683842) instead of the correct siz
There is a possibility that some accessories packaged between October 10 and October 12 may contain particulate matter from
Digital electron variable applicator is compliant with IEC60601-2-1 except for radiation leakage at distance of 2cm from the side
A number of complaints have been received regarding false positive results for lot 97266. Internal evaluation of this lot was com
Dale models 240 & 242 blue tracheostomy tube holders are breaking as a result of customers altering the product by trimming t
Release a safety advisory letter to sites affected by a potential safety issue with the display of portal images used for position co
 Limited number of devices may be prone to separation of internal connections (lifted wire bonds) between the electronic circuit
Some units from the lot were packaged without the etch information on the rim and without locking rings. / Certaines unités du lo
Manufacturer has determined that some Peep 10 reusable Peep valves do not hold the set peep level when used in certain con
When using with some types of disposable sensors, an SPO2 saturation level of 100% may be displayed even though the senso
Through complaint review, Hill-Rom discovered that there were some cases of "false latching" in Versacare bed side rails which
Certain lots of i-STAT Cartridges have snap closures that are difficult to close, will not close or do not stay closed. This may resu
                                                                                                  Il
Possibility of operator pinching their finger between the fixed roller and the gliding tabletop. /
existe un risque pour l‟opérateur d
BD has determined that issue exists with customers with a combination of OSX Operating System Multiset version 2.1 and later
Leaking lysis racks may compromise the integrity of the test specimen. / Des fuites dans les supports pour tubes de lyse risquen
The aortic length provided by the aorta analysis protocol could be overestimated, which could lead to choosing a stent-graft that
BD has determined that the housing posts may potentially break during activation. Subsequently the blade holder may fall out of
A real-time stability test revealed an increased variability in the metabolite values. / Une étude de stabilité en temps réel a révélé
Some ventilators may experience a condition where power to the Esprit display's backlight is interrupted, causing the user interfa
Reduction of the stability after reconstitution of the thyroglobulin (TG) constituent of the Precicontrol Universal level 2. / Baisse d
The Conmed Frasier suction procedure part, which is part of the Medline Industries procedure pack, may have an inadequate se
BD has determined that these lots were manufactured with a defective cap. When the flip cap is removed it may cause the stopp
Addresses a potential unpredictable component failure: specifically, a defective 0.01UF multi-layer ceramic chip capacitor. The d
There could be a presence of Burkholderia cepacia in the defogging solution, lot 000025622. / Présence possible de "burkholde
Affected lot number was imported into Canada and sold prior to licence amendment approval by Health Canada. / Le numéro de
The axsym gentamicin reagents are demonstrating a decrease in the calibration a-f span over time. / Les réactifs de AxSYM Ge
The x-ray high voltage generator installed in the gantry may fail due to insufficient heat radiation for Asteion systems. / Le génér
The sterilization of the product is not performed according to ISO 11135 standards. Coloplast is not able to guarantee the sterili
If devices are programmed to specific parameters, software anomaly may present clinically as a reset of pacemaker or inhibition
Genitals of some male patients may slide under the seat while it is raised from its lowest position or while in a raised position. W
When a patient link is running the affected software and a change is made to the caregroup editor configuration at the patient lin
In some instances, the occurrence of impacts has compromised the pumping mechanism within the pumping channel causing h
An unapproved sealing technique is believed to have possibly been used on these devices. A similar technique was previously d
Pump tubes that the yellowish/white tube may break off at the black plastic connectors.The breakage may occur during the insta
The lot of Endopath 5mm curved dissector with monopolar cautery is being recalled because the possibility exists that damage t
Modification of some Genesis II alignment guides to facilitate cleaning without approval of the manufacturer. / Des modifications
Sensors falsely alarmed. Depending on user-defined config. of perfusion system, arterial pump may respond to the alarm state
Corrupt database indices in the specimen management database could cause the misassociation of test and test result for a sp
Unit display went blank when the start button was pushed and the pump did not start. Caused by internal mounting screw makin
If percutaneous line is subjected to sustained bending or extreme flexing immediately adjacent to pump housing when placed pa
When converting from the factory-set units, selection set 1, to modified SI units, selection set 3, the results may not be appropria
The white film portion of the sterile pouch may become brittle prior to the end of the 60 month expiry date for products with an ex
The integration of the two software systems created a potential for demographic and sample type mismatches of labelling in som
Insulation is not present. If device comes in contact with a monopolar electrosurgical device there is potential for arching and da
The CT number may shift due to a problem in the processing circuit for the data used to correct variations in the x-ray intensity,
Software does not refresh in certain circumstances and erroneous results may be generated. / Le logiciel ne se rafraîchit pas da
Product specification failure of low absorbance leading to failed calibrations on automated analyzers. / Défaut des spécifications
A slide prepared by the slidemaker from a sample that is analyzed immediately after a control is processed may exhibit the pres
Erroneous results can occur if cytosettings are imported during acquisition. / Des résultats erronés peuvent se produire si les pa
 New limitation added: clinically relevant plasma levels of cubicin cause a significant concentration-dependent false prolongation
There is a possibility that the wheel caster(s) may become loose which may result in the wheel caster(s) falling out of the base o
Faulty batch of motors. The defectiveness can be seen in the loss of grease in the speed reduction unit. / Lot de moteurs défect
A fault was discovered in the packaging machine causing a possible defect peel pouch in one out of six peel pouches leading to
There is a potential risk that if a vent-pipe problem occurs, helium gas could escape into the imaging suite. This applies to an ide
There could be a presence of burkholderia cepacia in the defogging solution. / Présence possible de "burkholderia cepacia" dan
Manufacturer has determined that some Peep 10 reusable Peep valves do not hold the set peep level when used in certain co
There could be a presence of burkholderia cepacia in the defogging solution. / Présence possible de "burkholderia cepacia" dan
Product sterility may be compromised due to failure of the seal packaging. / La stérilité du produit peut être compromise en raiso
If a sensor becomes defective only a visual alarm will be displayed on the instrument, it is how the instrument was designed, a s
The potential for weld failure in the mattress cover. A total of 84 complaints have been received reporting weld failures in the 37
Leak may occur near spike port on secondary platelet collect bag. Leak is very small and occurs consistently in same location,
A mismatch could occur between the demographic data of 2 patients when they are replicate from the production database to th
Light-coloured residue occasionally been observed on instruments, trays following sterilization, infrequent hydrogen peroxide co
A real-time stability test revealed an increased variability in the metabolite values. / Une étude de stabilité en temps réel a ré
Balloon cuff may cover inflation hole causing balloon not to deflate. / Le manchon du ballonnet peut obstruer la valve de gon
Large
roller
pump
may
experience
overspeed
error
when
starting
rotation,
preventing
pump
from
operating
until
the
conditio
Pump
may
stop
without
an
audible
tone
as
a
result
of
a
quickly
clearing
internal
pump
alert/alarm
or
overpressure
alert/alarm
Battery
service
message
"Battery
Needs
Service:
Full
backup
may
not
be
available"
may
appear
even
if
the
battery
is
fully
fun
Pump
may
lose
communication
with
the
central
control
monitor
causing
the
monitor
to
display
a
service
message
and
becom
Air
bubble
detection
system
may
falsely
continue
to
sound
the
air
alarm
after
it
has
been
turned
off.
/
Le
système
de
détectio
The Versys Advocate Femoral Stem was packaged with the centralizer that accompanies the CPT Femoral Stem that is also dis
If
the
pump
is
exposed
to
strong
magnetic
fields,
it
may
exhibit
over-delivery
potentially
resulting
in
severe
hypoglcemia.

Use
The
centrifuge
chamber
carriers
have
been
found
to
be
out
of
specification
tolerance
limits
which
could
lead
to
increased
diff
Roller
pump
pauses
in
response
to
a
pressure
alarm
condition,
as
designed,
and
may
not
resume
operation
as
expected
when
Needle
may
separate
from
the
hub.
/
L’aiguille
peut
se
détacher
de
l’embout.
BD
US
discovered
bottle
to
bottle
variability
in
stability
for
the
lot
65857
of
Procount
Progenitor
Cell
Enumeration
Kit
(340498
Product
is
adulterated
with
clavulanic
acid.
/
Le
produit
est
altéré
par
l’ajout
d’acide
clavulanique.

Revision
of
current
software
to
address
excessive
fluid
removal
during
ultrafiltration
treatment
and
reduce
the
likelihood
of
o
For
10-20-30ml
heparin
syringe
carrier:
New
instructions
on
how
to
correctly
load
syringe
in
new
heparin
syringe
carrier.

If
th
The
hand
crank
handle
may
separate
and
detach
from
the
unit
during
use.
/
La
manivelle
peut
se
séparer
et
se
détacher
de
l’u
Incorrect
value
assignment
of
calibrator
F
(lot
08096)
resulting
in
possible
non-linear
dilution
of
samples
and
lower
than
expe
When two product applications called flip and secondary capture are used together, it is possible for the image orientation la
Product
is
not
performing
acceptably.
/
Le
résultat
de
ce
produit
n’est
pas
acceptable.
Analysis
of
manufacturing
test
data
indicates
that
this
device
may
have
a
cracked
layer
of
insulation
in
a
flexible
hybrid
circuit
Class III Medical Device sold without a licence. / Instrument médical de Classe III vendu sans autorisation de mise en marché.
An increase in the incidence of the error message "Error code 19" during the process of data saving could impair the tracing o
The
Ralco
302
ACS
collimator
on
the
DR3000
does
not
digitally
display
the
field
size
and
SID
after
the
detector
was
disabled
a
Potential
loosening
of
the
braze
where
the
tip
is
joined
to
the
body
of
the
probe
which
could
result
in
the
tip
being
propelled

Phosphorus, HDL, Cholesterol, LDL Cholesterol and triglycerides are not meeting stability claims. / Stabilite du phospore, HDL
The
kit
label
is
erroneous.
The
expiration
date
on
the
kit
label
indicates
the
expiration
date
is
July
2,
2007,
however,
the
short
Internal
investigation
confirms
Access
Free
T3
open
pack
stability
claim
of
28
days
is
not
being
met
on
a
consistent
basis.
/
Un
MXP
User
documentation
does
not
adequately
characterize
use
of
live
gate
feature.

Improper
use
of
the
live
gate
region
may
Some
heat
exchangers
in
these
administration
sets
may
have
a
leakage
of
the
inner
lumen
which
may
allow
the
heating
fluid

An
erroneous
trajectory
may
be
generated
for
an
angled
or
bent
tool,
which
could
result
in
patient
injury.
Also,
surgical
plann
Oil
may
leak
onto
the
port
window
of
the
ct
tube
and
may
result
in
image
artifacts
that
could
lead
to
mis-diagnosis.
/
De
l’huil
If manual cradle release is used instead of the table control buttons, a possible mis-diagnosis may occur and healthy tissues ma
The
BacT/View
Software
used
with
BacT/Alert
classic
installation
will
be
unable
to
run
scheduled
macro
applications
unless
th
Complaints
received
of
increased
"reactive"
and/or
positively
biased
results
with
samples
collected
in
sodium
citrate
or
Edta

Software
anomaly
that
causes
the
pump
to
experience
a
sudden
and
unexpected
failure.

The
anomaly
occurs
during
the
pum
Defect
was
discovered
in
Isite
Pacs
that
may
cause
patient
image
orientation
markers
to
be
incorrectly
labelled
on
multi-plan
Small
number
of
reagent
kits
were
incorrectly
configured.

Affected
kits
contain
either
two
bottles
of
conjugate
or
two
bottle
The product is labelled as reusable but there is a potential that the cannulated handle of the product cannot be cleaned adeq
While the system is saving data to the disk drive, a sudden loss of power can cause patient data stored on the system to becom
The
system
has
a
gap
that
can
appear
between
the
upper
and
lower
tilt
stand
covers.
The
fingers
may
be
squeezed
if
a
person
A dimension table on the product drawing/blueprint incorrectly displayed the head neck length in that the +0 dimension and
The
manufacturer
recently
withdrew
its
20
gauge
high-speed
vitrectomy
cutters
due
to
reports
of
probe
tip
breakages.
While
Affected lot numbers may exhibit elevated troponin-I results that exceed the recommended risk stratification of 0.1 ng/ml wi
The
RADIANCE
Data
Management
program
allows
manual
editing
of
patient
information,
e.g.,
FIO2
(fraction
of
inspired
oxyge
The
mounting
bolts
that
secure
the
single
tank
fork
assembly
and
the
mounting
bolts
that
secure
the
collimator
flange
could
p
Realization
of
ultrasound
positioning
and
system
improvement
i.e.
improvement
of
the
software
and
cable
connections
to
pr
One lot exhibiting a decrease in sensitivity, which could affect qualitative results and produce false negatives and incorrectly i
When
studies
are
split,
segmented,
fixed-up
or
merged
using
Impax
qc
or
service
tools
and
then
loaded
into
Medicad
or
Voxa
The
safety
valve
may
remain
open
after
an
occlusion
is
resolved.
If
safety
valve
does
not
reset
the
ventilator
will
not
resume
n
The
end
cap
component
may
become
disassembled
after
repeated
depression
while
installed
in
the
high
speed
handpiece.
/

The
smart
box
has
failed
to
prevent
unintended
movement
of
the
gantry.
/
La
smart
box
n’a
pas
permis
de
prévenir
les
mouv
Stability
issue
that
impacts
the
shelf
life
and
calibration
stability
of
benzodiazepine
reagent.
/
Un
problème
de
stabilité
du
pro
Safety
alert
to
clarify
that
the
adverse
effects
listed
in
the
instructions
for
use
apply
to
both
implant
and
explant
procedures,

During
incoming
inspection
of
devices
in
various
distribution
centres,
it
was
detected
that
certain
batches
of
the
matrix2
deta
The
results
of
anticoagulant
studies
showed
K2EDTA
tubes
are
incompatible
with
co2
using
Bioban,
Bioban
plus
and
NS
ISE
re
Possibility
of
system
lock-up,
incorrect
image
display,
incorrect
dose
area
product
calculation,
&
system
fails
to
boot.
/
Risque
Possibility
of
system
lock-up,
incorrect
image
display,
incorrect
dose
area
product
calculation,
&
system
fails
to
boot.
/
Risque
Possibility
of
system
lock-up,
incorrect
image
display,
incorrect
dose
area
product
calculation,
&
system
fails
to
boot.
/
Risque
Failed
calibrations
for
a
specific
lot
due
to
calibrator
A/Adj1
a
rates
and/or
calibrator
A/B
ratio
exceeding
the
assay
file
validit
Potential
breakage
or
bending
of
the
clamp
slot
door
latch,
designed
to
hold
the
air
detector
door
in
the
closed
position.
/
Ris
Devices
with
software
2.002
and
earlier
may
clear
a
"low
battery
or
replace
battery"
warning
that
was
detected
by
an
autom
Analytical
sensitivity
label
claim
of
less
than
or
equal
to
0.01
ng/ml
(ug/l)
might
not
be
met
for
all
lots
of
Architect
Stat
Tropon
We
have
recently
determined
that
devices
within
the
identified
batches/lots
may
deploy
with
excess
deployment
force.
Devi
Some
changes
have
been
made
to
the
instructions
for
use
(ifu)
for
the
device
to
address
potential
risks
associated
with
the
us
If
the
fluid
warmer
is
powered
off
in
an
active
alarm
state,
the
air
detector/clamp
will
open
and
the
air
detector
will
become
d
The manufacturer issued notice 17 to announce version 3.0 of the prismaflex software, which aims to correct problems assoc
The manufacturer issued notice 16B to announce the replacement of weight scales, the rotor of the blood pump, the air bubb
ABG
kits
outer
labels
incorrectly
identified
as
containing
200
units
of
heparin,
when
in
fact
the
3cc
syringe
only
contains
100
u
A
Defibrillator
pad
with
a
Medtronic
connector
may
potentially
contain
a
Zoll
connector
or
vice
versa.
This
error
makes
the
pr
Sterility
barrier
on
a
limited
number
of
units
is
compromised
by
a
pinhole
in
the
sterile
pouch.
/
La
stérilité
d’un
nombre
limité
Pinching
patient
between
headrest
&
collimator
edge,
gated
studies
lost
after
edit
patient
info.,
scan
paused
without
request
The instrument may give white blood cell counts of 300-400k when the actual count is greater than 600k. When the red blood c
1)
Absence
of
black
indicator
markings
on
the
metal
tip
and
2)
fiber
degradation
(degradation
of
fiber,
detachment
of
metal
c
Educational
brief
issued
to
remind
clinicans
of
appropriate
drug
administration
and
monitoring
procedures
which
will
reduce
r
The
nose
cone
attachment
to
the
body
of
certain
lots
of
removal
tools
do
not
contain
sufficient
adhesive
which
can
cause
the
Contamination
in
a
subset
of
vials
of
VYSIS
LSI
ATM/P53
AND
D13S319/CEP
12/13Q34
probes
with
LSI
ATM
SG/P53
SO
probe
The
recall
is
in
response
to
several
reports
from
surgical
centres
citing
topographically-observed
"central
islands"
in
patients
fo
The lag screw insertion handle does not lock into the t-handle. Discrepancy in size of insertion handle and t-handle which make
Decreased
precision
in
the
low
end
measuring
range,
below
the
therapeutic
decision
range.
/
Précision
diminuée
dans
les
vale
The luer-port in the expiratory elbow may be occluded, which interferes with a ventilators ability to detect an accurate pressu
BD
is
concerned
that
some
product
may
contain
a
problem
that
could
cause
the
non
patient
needle
(in
the
holder)
to
become
Due
to
a
software
anomaly,
Medtronic
requested
all
investigators
suspend
new
enrollments
into
the
canfusepace
study
and
t
BD
is
concerned
that
the
blade
foil
package
may
not
be
properly
sealed.
/

La
société
BD
est
préoccupée
par
le
fait
que
l’emba
The
locking
pins
of
the
radiolucent
drill
guide
drop
may
not
have
been
assembled
correctly.
The
locking
pin
may
not
function

The manufacturer issued the advisory notice #19 to provide instructions and procedure to clear flow rate discrepancies without i
The tubing of lot 07m15751 may have been assembled with the wrong arterial line, and the arterial clamp may not be strong
Baxter
has
inadvertently
shipped
product
without
CSA
approval.
/
La
société
Baxter
a
involontairement
expédié
un
produit
qu
A
small
number
of
pumps
may
power
off
with
a
single
key
press
of
the
on/off
key
and
the
audible
speaker
tone
at
power
on
m
Wrong value displayed in cardiac measurement mode in Aplio systems with version 6 software. / Les systèmes Aplio munis de
Higher
than
average
incidence
rate
of
leakage.
/
Le
taux
d’incidence
de
fuite
est
supérieur
au
taux
moyen.
The manufacturer will be releasing a software update - system version 2.0.9. / Le fabricant mettra sur le marché une mise à jou
Inform
customers
that
service
mode
is
only
for
use
by
authorized
personnel.
/
Informer
les
clients
que
l’utilisation
du
mode
m
New securing rails are now necessary to prevent unintended removal of the table inserts. / De nouveaux rails de fixation sont
Some
kits
of
one
lot
were
incorrectly
configured.

The
affected
kits
contain
reagent
bottles
in
the
order
S-W-T-P
instead
of
the
Presence of dose-hook effect for VWF-AG levels above 300% for three lots of STA-LIATEST VWF-AG. / Trois lots de STA-Liatest
Low
voltage
capacitors
from
a
former
supplier
which
may
cause
accelerated
battery
depletion
and
may
reduce
the
time
betw
During
incoming
inspection,
it
was
detected
that
certain
batches
of
Matrix
2
detachable
coils
were
missing
the
temperature
i
A
button
on
the
front
panel
may
not
respond
to
an
initial
button
press
and
may
require
additional
button
presses
or
additiona
The possibility exists that in certain units the adhesive used to bond the casing of the device may have migrated to the staple
If
the
CADD
adminstration
set
is
incorrectly
attached
to
the
CADD
pump,
unregulated
gravity
flow
to
the
patient
can
occur.

If
Significant
hemolysis
or
unexpected
color
with
a
lot
of
checkcells
(pooled
cells).

Investigation
has
identified
microbial
contam
Molt
Periosteal
Elevator
#9
may
not
have
been
polished
completely
which
may
cause
the
instrument
to
discolor
when
cleane
There
is
a
potential
for
erroneously
high
basophil
results
to
be
generated
by
the
ACT
5Diff
Analyzer
Systems
when
a
sample
w
The
total
protein
values
were
incorrectly
value
assigned
and
published
on
the
value
assignment
inserts
supplied
with
the
kits.
The control tube stoppers are being pushed into the bottle when the tube is pierced resulting in a potential biohazard. / Le bo
The leur-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate press
When
data
from
these
systems
contain
reconstruction
offsets,
the
absolute
marking
coordinates
computed
within
virtual
fluo
The assay lists the absolute count for level 1 as 4.3, where it should be 3.5. / . Le décompte absolu du niveau 1 indiqué sur la f
Manufacturer
of
product
has
received
reports
of
the
bolt
that
holds
the
scale
on
the
lift
coming
lose,
resulting
in
the
hanger
b
A
potential
packaging
issue
has
been
identified
with
the
primary
pack
of
the
guardian
device.
During
transport
testing
of
a
new
After
pressing
the
ignore
button
several
times
after
plate
transport
error
messages
appeared,
the
instrument
read
the
first
pla
Potential for an intermittent electrical contact from a cable to a connector. / Il se peut que le contact électrique entre un câble et
1)
Problem
with
the
image
processing
software
that
rotates
collimator
coordinates.

  2)
an
operator's
finger
was
pinched
betw
The default pulse rate may be set to 25/30 pulses per second (pps), which may result in a dose rate in excess of 20r/min. / La
Possible
problems
with
tracking
accuracy
involving
the
distortion
map
that
is
used
for
calculating
position
during
image
tracki
Possibility of accidental operator initiated activation of gantry movements associated with the new metallic smart box contro
Housing
of
pin
transmitter
is
designed
to
have
a
small
pin
through
each
sidewall.
The
stainless
steel
tip
has
disconnected
from
Weld between the post body and the screw was not properly formed and may fail even when minimal force is used, which could
The part was laser etched and packaged as a 32mm but part measures a 28mm. / La pièce a été polie au laser puis emballée c
Problems with loss of audible alarms and cic resetting. / On signale des problèmes de pannes des alarmes sonores et de réini
Packaging
mislabeling
issues.
Potential
discrepancies
on
the
lot
number,
the
size
indication,
the
tag
on
the
product
and
the
de
Manufacturer
has
received
complaints
of
various
amounts
of
anticoagulant
in
between
the
donor
needle
and
the
sampling
po
A
possibility
of
continued
activation
of
the
device
after
the
button/foot
switch
is
no
longer
depressed
due
to
ingress
of
liquid

Burning
sensation
and
irritation
of
patient
after
usage.

Testing
of
the
lot
used
revealed
that
the
gel
did
not
meet
the
specifica
Use
of
an
incorrect
(black)
collet
and
nut
during
atrial
and
ventricular
cannulation
can
result
in
sudden
cannula
disconnect.
/
L
Correction to this recall previously posted on 2007-02-19. / Correction apportée à ce rappel affiché le 2007 février 19. 
      

Risk of disconnection of portable patient lift from attachment handle if used with the original, smaller carabiner. / Risque de d
An increase in calibration failures has been observed due to elevated calibrator a rates when testing the reagents stored at the r
R2
reagents
of
both
ch:
acn
057
and
ck-mb:
acn
060
assays
have
false
positive
carryover
effects
on
the
online
tdm
valproic
ac
Reports have been received that longer than expected clotting times have been observed. / Des rapports indiquent que des t
Intermittent
failure
of
the
stirrer
motor
results
may
lead
to
incorrect
glucose
results.
/
Des
défaillances
intermittentes
des
rés
Additive
content
labelon
bd
microtainer
tubes
is
incorrect
for
the
bag
and
case
carton.
The
graphics
indicate
that
the
additive
Potential
misidentification
of
samples.
/
Possibilité
d’erreur
d’identification
des
échantillons.
Mounting point may break and allow the monitors to become loose or fall off the system. / Le point de montage peut se briser et
The luer-port in expiratory elbow may be occluded, which interferes with ventilator's ability to detect an accurate pressure re
Bacterial contamination of microbiological media. / Contamination bactérienne des milieux de culture.
Growth
promotion
failure
of
qc
organism
(atcc
12386,
streptococcus
agalactiae).
/
Échec
de
la
croissance
de
l’organisme
de
c
A
report
was
received
from
a
customer
in
Nairobi
stating
that
the
values
quoted
on
the
cd
for
280se
were
not
those
for
an
el
The
battery
pack
for
the
Ceegraph
Netlink
Traveler
may
be
damaged
and
overheat
if
placed
into
the
unit
incorrectly.
/
La
batt
Production
operation
was
missed
on
the
manufacturing
floor
and
the
stops
used
as
a
depth
ref
were
left
off
the
product.
/
Éc
Potential
for
a
breach
to
the
sterile
barrier.
The
breach
was
determined
to
be
the
result
of
cracking
of
the
PETG
tray
at
the
ra
Secondary
(piggyback)
infusions
backing
up
past
a
back
check
valve
(BCV)
into
the
primary
infusion
line
and/or
container.
/
Pe
Patient samples with very low concentrations of troponin I could be negatively biassed and may be incorrectly reported as less th
Certain
catalog
numbers
and
lots
of
devices
sold
as
unboxed
single
units,
may
exhibit
packaging
material
failures
before
the
la
BHIA
+
vancomycin
(microbiological
media)
did
not
appear
to
inhibit
vancomycin
sensitive
enterococcus
isolates
in
quality
co
The
owner's
booklet
sent
to
users
between
April
2004
to
October
2006
listed
the
incorrect
hematocrit
range
for
test
strips.
T
An error was identified in the HD11 diagnostic ultrasound system with software revision 1.2. with certain keystroke this state
S8
series
flow
generators
(autoset
vantage,
compact,
elite,
escape)
manufactured
before
May
15

2006
show
low
incidence
o
There may be a performance issue with the reagent not meeting its 1000 mg/dl linear specification, particularly when it nears its
For
certain
lots,
results
for
normal
and
abnormal
control
plasmas
were
recovered
in
the
low
range
of
the
assigned
values
and
Reassesment
of
the
functional
sensitivity
of
Cortisol
Elecsys
cat
number
11875116122,
all
lots.
The
currently
claimed
function
If
the
opening
of
the
venting
outside
of
building
is
not
according
to
specifications,
rain
could
enter
the
system
during
a
cryoge
Some
Axsym
and
IMX
total
B-HCG
lots
may
give
elevated
patient
results.
Performing
manual
dilutions
with
the
total
B-HCG
sp
It turned out that the calibration factor may become bordeline when the reagent kit is kept on board for more than 6 weeks for al
Following
internal
testing,
mfr
has
identified
that
hemoglobin
can
interfere
with
the
elecsys
PTH
assay
at
value
higher
than
0.
Failure
to
actuate
(open)
some
reagent
packs.
The
following
can
result
in
probe
crashes
if
not
detected:
separation
of
the
flip
Some Agar surfaces of the lot 7c1025 can give false positive results. / Certaines gélose du lot 7c1025 peuvent produire des re
A
Small
number
of
enteral
pump
sets
have
a
1-3mm
slit
in
the
silicone
tubing
located
between
the
blue
connector
and
the
str
Dental
implants
which
lacked
the
proper
instruments
for
implantation
were
distributed.
Handpiece
and
ratchet
adapters
and
The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature w
There
have
been
reports
that
waste
fluid
has
sprayed
out
from
the
waste
drain
at
the
front
of
the
ABL80
analyzer.
This
occurs
The
seat
lift
washers
may
deform
causing
seats
to
wobble
and
if
not
repaired
or
replaced,
may
eventually
fail.
Warning
about
The retaining screw for the gonad protector on the velocity U was broken. / La vis de retenue du protège-gonades du Velocity
Data
file
containing
one
or
no
fluorescence
parameters
is
exported,
the
software
automatically
applies
compensation
to
the
f
A new software version is available for the heater cooler unit 30 system. / Une nouvelle version du logiciel est disponible pou
An
important
safety
notice
is
being
distributed
to
c.cam
customers
with
systems.
The
solution
described
in
the
letter
is
to
upd
Customers
have
been
reporting:

   1)error
codes
(1062,1063,1113,1118)
when
running
patient
samples
and

     2)patient
sample
A potential issue with the 2gb sanbiocraid component used in magicstore systems. / Il existe un problème possible avec la co
For the Architect C8000, reagent package insert, 30-3143/r5, incorrectly displays results in SI units (Standard International) as m
A potential Lock-up condition exists on Allura XPER 10/10 Rel 1 and RD 10 Rel 2 systems requiring a reboot of the system. / Le
There
is
the
possibility
that
the
retaining
ring
that
holds
check
valve
components
inside
of
the
nipple
assembly
may
not
be
fu
Base
casting
deviation
from
approved
design
specifications.
Unapproved
change
consisted
of
deduction
in
the
number
of
ma
Possibility of a false indication of sensitivity to metronidazole with some organisms. / Le disque peut donner une fausse indica
When
the
on/off
button
is
pressed
for
more
than
3
seconds,
the
ventilator
will
not
start.
/
Lorsqu’on
appuie
plus
de
3
second
In certain situations, volumes dispensed by the device are lower than expected. / Dans certaines situations, les volumes préparé
Potential for the enhanced display housing to rotate about its mount resulting in the wire harness coming out of the casing. The
Sporadic absolute count recovery failure and flurescent populations containing more than 20% of the total population. / Le fluoro
The software can create a protocol which will not display the correct data in some plots and will not update the sample ID1 field
It was found that this specific catheter has regulatory status as both a diagnostic and a therapeutic catheter. In some cases, the
There
are
inadequate
warnings
on
the
instructions
for
use
(IFU).
/
Des
mises
en
garde
inadéquates
figurent
dans
le
mode
d’em
The
hinged
lids
of
the
accelerator
aps
can
fall
if
the
lids
are
not
fully
opening
as
designed,
representing
a
potential
hazard
to
t
Products received from Biomet Microfication are of the incorrect length. / Les produits reçus de la société Biomet Microfixati
Specific
lot
of
the
activation
reagent
bottles
have
been
identified
to
have
caps
that
spin
freely.

Loose
caps
could
lead
to
pote
Immucor
has
had
reports
of
weaker
or
negative
reactivity
with
weak
D
cells
when
testing
is
performed
using
lot
18943.
/
Imm
The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature w
A
shift
in
patient
results
may
be
observed
between
some
reagent
bottles
from
the
same
lot.
A
maximum
shift
in
patient
samp
Fully
extended
patient
pallet
could
come
into
contact
with
the
pinhole
collimator,
resulting
in
system
damage.
/
Lorsqu’elle
e
The Gentamicin reagent fails to calibrate on most Synchron LX and Unicel DVC systems. / L‟étalonnage du réactif gentamincine
The manufacturer has received reports of disconnections/leaks. / Le fabricant a reçu des rapports signalant des cas de déconn
A pattern of premature battery depletion in device manufactured with a single lot of low-voltage, ceramic capacitors was identifie
The
XIO
underestimates
the
penumbral
dose
when
a
siemens
linear
accelerator
is
used
where
the
MLC
‘s
define
a
straight
ed
Gantry
drive
chain
may
break
during
gantry
motion,
allowing
gantry
to
rotate
without
motor
control,
which
may
collide
with

If
planning
systems
don't
export
patient
orientation
with
plan,
that
field
defaults
to
"none".
If
user
edits
field,
couch,
collimet
Correction to the potential trip hazard with the patient pendant cord if the cord management device is not being used. / Correctio
Weak positive reactions in direct antiglobulin tests resulting in additional antibody testing by the customer. / Réactions positi
When
motion
enable
bar
is
pressed,
machine
may
produce
unexpected
motions
from
couch,
collimator
and
gantry
rotation
a
Since
the
product
does
not
currently
pass
the
re-autoclave
sterilization
validation
at
the
15
min
half
cycle,
Dentsply
Friadent
C
Calibration
solution
for
ABL700
blood
gas
analysers
is
labelled
with
an
incorrect
bar
code.
The
bar
code
identified
on
the
cal
s
Formation
of
deposit
of
gel-like
substance
in
the
measuring
cell
of
the
elecsys
2010
when
used
in
combination
with
the
Elecsy
Manufacturer
has
identified
a
defect
in
the
gels
of
the
kits.
This
fault
results
in
the
emergence
of
an
additional
artifact
band
a
The
audio
alert
speaker
component
may
fail
resulting
in
no
audible
alarm
during
an
alert.
The
monitor
will
continue
to
display
Microalbumin
multi-calibrator
set
has
transposed
vial
labels
on
levels
5
and
6.
The
concentrations,
10
mg/dl
and
30
mg/dl,
lis
A
possible
fault
in
the
foil
the
bags
are
made
of,
stick
after
storage
and
result
in
not
allowing
urine
to
flow
into
the
bag.
/
Il
peu
Product
has
lower
than
expected
concentration
levels
of
the
chemical
cure
initiator,
benzoyl
peroxide,
which
can
result
in
bon
Manufacturer
has
discovered
that
pump
channel
was
placed
in
the
incorrect
slot
during
servicing,
the
label
on
the
channel
do
Benchmark
instrument
may
short
resulting
in
burned
or
cracked
communication
wire
if
incorrectly
serviced
(by
technical
eng
Manufacturer has determined that footswitch supplied with periowave system is lacking a shroud. There is a small potential for
Handpiece
supplied
with
Periowave
system
has
potential
for
damaging
the
optical
surfaces
by
over
tightening
of
the
optical
c
Lorenz Pectus Support Bar, 14in midline ETCH could be off center. / La ligne gravée au centre de la barre de support Pectus d
Becton Dickinson is concerned that some product may produce a false negative result. / La société Becton Dickinson craint qu
Waste
sensor
&
software
has
potential
to
fail
if
waste
container
is
moved
from
instrument
wall
&
operator
overrides
sensor's
Becton
Dickinson
USA
discovered
that
lot
number
45602
of
the
BD
Procount
Progenitor
Cell
Enumeration
Kit
(material
no
340
Lactosorb
suspension
screws
were
breaking
during
insertion.
/
Les
vis
résorbables
Lactosorb
se
sont
brisées
pendant
l’insertio
Gambro
rostock
has
become
aware
of
several
complaints
concerning
pump
segment
ruptures
within
the
mars
albumin
circuit
Therapist may inadvertently change couch & machine parameters by using override/acquire actual button on 4D console which
Increase
was
observed
in
the
number
of
poor
vision
complaints
with
CSI
Lenses.

Investigation
showed
the
base
curve
to
be
s
The
EnPulse
post
sterilization
test
specification
inadvertently
specifies
an
incorrect
location
for
the
activity
fine
trim
(AFT)
val
Two
lot
numbers
are
exhibiting
reduced
stability,
causing
problems
with
calibration
such
as
duplicate
errors,
linearity
flags
an
The
incorrect
caution
label
that
describes
washing
instructions
was
applied
to
the
beds
distributed.
The
french
label
was
used
Broken
bond
wires
have
been
observed
between
the
battery
and
electronic
hybrid
inside
the
neurostimulator.
/
À
l’intérieur

Punches
were
not
manufactured
to
our
specifications
and
the
tip
of
the
punch
is
welded
on
and
not
one
piece
as
specified.
Th
Certain
compact
absorbers,
used
only
with
the
GE
Healthcare
ADU
Anesthesia
systems,
may
have
an
increased
resistance
to
g
When
Gentamicin,
Digoxin,
Phenytoin,
or
Theophylline
precede
Valproic
acid,
the
Valproic
acid
test
result
is
artificially
low.
/

Devices
with
V38
software
may
shut
down
without
warning
when
operating
on
backup
(dc)
battery
power.
/
Les
dispositifs
éq
Carabineer
may
not
be
correctly
attached
to
the
reacher
and
lift
may
drop.
BHM
device
should
be
redesigned
prior
to
continu
The
manufacturer
has
become
aware
of
several
events
of
access
pressure
pod
leakage
when
unloading
the
Prisma
sets
from
t
Agglutination
absence
of
the
sensitized
latex
(R1)
with
the
positive
control
(R3).
/
Absence
d’agglutination
du
latex
sensibilisé
Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy. / U
Alert
users
that
improper
shutdown
sequence
could
cause
a
spool
in
the
v
pneumatic
component
in
the
device
to
stop
in
an
in
False-positive results have been observed with the gen 56 formulation. Calibrator values must be adjusted to improve correla
Magnesium
reagent
package
insert
24-hour
urine
magnesium
mg/day
reference
range
is
incorrect.

The
incorrect
values
are
7
There
has
been
an
increased
number
of
invalid
runs
due
to
controls
outside
the
package
insert
range
with
lot
29506m100.

Co
The
outer
diameter
(OD)
documented
on
the
tray,
inner
and
outer
box
labels
did
not
match
the
OD
printed
on
the
tube
flang
Product
is
no
longer
meeting
specification.

Inconsistent
values
have
been
reported.
/
Le
produit
n’est
plus
conforme
aux
nor
Outside
packaging
of
some
units
labelled
with
incorrect
lot
number
(missing
prefix:
"5-").

Pouches
containing
test
strips
had

Valve
disk
material
(lot
#20052904)
utilized
inside
compressor
(housed
inside
driver)
has
tendency
to
stick
creating
compress
Confirmation
dot
on
the
back
of
some
test
strips
may
either
remain
white
or
not
turn
completely
blue
which
can
lead
to
erro
A
fix
gate
remained
in
the
"open"
position
when
rails
were
not
aligned.
The
ceiling
lift
reached
the
end
of
the
rail
and
fell
to
th
Architect CBT Kits 03E48-05 includes a job aid (96529-102) which contains labelling errors. / Les trousses d‟architecture de form
The
device
is
now
contraindicated
for
use
in
ligating
the
renal
artery
during
laparoscopic
donor
nephrectomies
as
the
device
m
Under
specific
circumstances,
the
paceart
system
2005
first
edition
may
indicate
detection
features
of
an
entrust
icd
as
enab
Defective
wheels
on
wheeled
walker.
The
cause
was
that
the
wheel
hub
thickness
went
from
5mm
to
4mm.
This
change
caus
 Following sterility tests on abdominal pads, 1 unit out of 10 was found to be non-sterile. / Suite à des tests de stérilité sur de
There
is
a
potential
for
erroneous
results
for
body
fluids
on
the
LH750
when
a
cassette
label
fails
to
read
and
the
subsequent

The couplers are locked up both in surgeries and post-operatively. The coupler will not rotate freely. / Les coupleurs sont bloq
Teleflex medical has identified that the product did not pass validated sterility test requirements. / La société Teleflex Medica
The metal insertion/introducer device may damage the guide wire by disrupting the adhesive coating of the guide wire. / Le d
Results
are
not
lining
up
correctly
on
the
report.
This
would
result
in
the
end
physician
receiving
a
report
that
could
provide
in
The
hematology
module
is
generating
test
data
for
tests
that
have
not
been
run.
When
the
system
reports
an
automated
diff
The
enpulse
post
sterilization
test
specification,
for
three
selected
serial
numbers,

inadvertently
specifies
an
incorrect
locatio
Mislabelling
issue.
Sawblades
labelled
as
Profix
(old
style)
Stryker
rather
than
Profix
hall
3/4
fanned.
/
Étiquetage
incorrect.
De
Patient may be exposed to unplanned radiation. / Le patient pourrait être exposé à des radiations accidentelles.
In
the
tube
transport
chain
sensor,
used
to
move
a
reaction
tube
within
the
Immulite
2000,
a
false
trigger
can
occur
due
to
pa
Devices manufactured between October 2005 and February 2006 contain a therapy connector that may have connector sockets
AGA(AGA
Medical
Corporation)
has
found
that
microscopic
tears
can
occur
in
the
sterile
packaging
under
accelerated
stress
te
4
potentiel
problems:
(1)
image
quality
problem,
(2)
unable
to
print
2
or
more
images
on
1
film,
(3)
possible
image
loss
when
To
provide
all
current
users
of
these
products
with
the
updated
instructions
for
use,
disassembly
instructions
and
how
to
iden
Two
incidents
occurred
in
the
uk
in
which
the
bolt
that
connects
the
lifting
arm
to
the
lifting
actuator
failed
due
to
wear
and
t
The
master
list
packaged
with
Panocell-16,
lot
35411,
contains
an
error.
The
bracketed
(*+)
D
negative
cells
do
not
contain
a
JK
Investigation
into
a
reported
incident,
in
which
a
hanger
bar
detached
from
the
device,
attributed
the
failure
to
a
loose
joint
b
False-negative
LIPA
results
can
occur
with
elevated
lipase
activities
of
1000
u/l
when
the
product
has
been
stored
on
a
Vitros
C
There
have
been
2
cases
where
one
of
the
four
castors
got
loose
due
to
a
break
in
the
trolley
chassis.
The
manufacturer's
ana
The company has been made aware of instances where the grasper jaws broke at the junction of the jaw and the tube during
Some
crutches
have
incorrect
installation
of
the
rubber
tips
onto
the
bottom,
bolts
used
in
the
crutches
may
be
defective
and
Hand
cranks
for
roller
pumps
in
hl20/hl30
delivered
since
august
1,
2005
may
be
defective.
The
defective
hand
crank's
steel
t
During
a
normal
workflow,
the
user
may
make
image
annotations
(eg.Text,
lines)
which
are
saved
as
overlays
on
the
patient
im
During
a
normal
workflow,
the
user
may
make
image
annotations
(eg.Text,
lines)
which
are
saved
as
overlays
on
the
patient
im
This
update
resolves
an
issue
regarding
a
potential
loss
of
images.
/
Cette
mise
à
jour
résout
un
problème
relatif
à
la
perte
po
Device
does
not
omit
rejected
quality
control
runs
when
the
qc
records
are
downloaded
to
a
diskette.

When
the
info
from
th
It
has
been
determined
that
a
design
anomaly
exists
in
the
power
supply
that
has
caused
the
device
to
remain
on
battery
pow
The part number 01-7172 (plate/wire cutter) may not fit into the container. / La pièce portant le numéro 01-7172 (coupe-pla
A
potential
gradient
amplifier
issue
when
using
the
Opart
MRI
system
equipped
with
the
Opart
integrated
electronics
cabinet
Welding
was
not
conducted

appropriately
at
a
couple
of
points
of
the
caster
holding
frame.
This
problem
relates
to
an
inade
An
incomplete
seal
of
the
package
compromises
the
sterility
of
the
product.
/
Le
scellage
incomplet
de
l’emballage
comprom
The
power
supply
circuit
fuses
in
the
detector
may
be
defective
for
the
device
manufactured
between
December
2002
and
Fe
Manufacturer
has
found
a
potential
to
report
incorrect
interpretations
of
ESBL
producing
organisms
and
antimicrobial
agents

Software
issues
for
ct
scanner
regarding
display
of
the
scanogram
of
the
previous
sconoscopy
and
failure
to
change
the
scan
r
Mislabelling
of
patient
information
at
raw
data
processing
for
the
device.
/
Erreur
d’étiquetage
de
l’information
sur
le
patient
Potential
for
erroneous
test
results
due
to
insufficient
Thromboplastin.
/
Possibilité
d’obtenir
des
résultats
d’analyse
erronés

The
puncture
of
the
distal
tube
by
the
mandrill
which
is
not
completely
inserted
in
the
catheter.
/
Le
tube
distal
est
perforé
p
Manufacturer
has
found
a
potential
to
report
incorrect
interpretations
of
ESBL
producing
organisms
and
antimicrobial
agents
Audio
alert
speaker
component
may
fail
resulting
in
no
audible
alarm
during
an
alert
condition.
/
Le
dispositif
du
signal
sonor
The manufacturer (Teleflex Medical) has identified that the device did not pass validated sterility test requirements. / La société
Users
reminded
not
to
place
objects
near
or
on
top
of
the
remote
control
console
as
these
objects
could
fall
and
inadvertently
(3)Cases of disassembly of the radial head reported. / (3) Des cas de fracture de la tête radiale ont été signalés.
Confirmation
dot
on
the
back
of
some
test
strips
may
either
remain
white
or
not
turn
completely
blue
which
can
lead
to
erro
Magnesium
reagent
package
insert
24-hour
urin
magnesium
mg/day
reference
range
is
incorrect.

The
incorrect
values
are
7.
The
"stop"
information
on
the
label
is
incorrect.
/
L’information
indiquée
sur
l’étiquette
concernant
la
«
butée
d’arrêt
»
est
er
There
is
a
bug
in
the
control
unit
software:
potential
risk
of
dropping
the
collimator
helmet.
/
L’unité
de
commande
du
logicie
Customers
using
a
bottle
id
barcode
labels
other
than
the
bact/alert
barcodes
may
be
at
risk
for
a
false
negative
result.
/
Les
c
This
update
corrects
a
problem
of
estimated
date
of
confinement
changing
when
a
previously
saved
OB
report
is
opened
on
t
Under
very
specific
load
conditions
in
conjunction
with
local
TX/RX
coils
there
is
a
rare
possibility
that
the
RFPA
may
oscillate.
The
reason
for
the
update
is
an
improvement
of
the
software
and
cable
connections
to
avoid
system
instabilities.
/
La
mise
à

Potential
risk
for
injuries
through
pinch
points
at
the
longitudinal
S
sides
of
the
patient
table.
This
risk
may
occur
when
the
ta
Low end imprecision was effecting both so calibrators and low level patient samples. / Une imprécision de la partie inférieure
If
the
device's
monitor
is
used
with
a
damaged
or
faulty
pulse
oximetry
cable
exhibiting
a
specific
kind
of
short,
the
sensor
ma
Device may report incorrect WBC results for sickle cell patient samples. The WBC result can be overestimated by more than
Calibrators are not performing adequately leading to failure of assay standard curve. / Les calibrateurs ne fonctionnent pas pa
Possible
blockage
of
the
recirculating
warming
fluid
channel
wthin
the
disposable
administration
set.
The
manifold
on
the
sets
Hemoglobin
results
in
donor
samples
assayed
on
the
cell-dyn
1800
system
vary
more
than
expected
across
the
range
of
claim
An
underestimation
of
N
Latex
LP(A)
values
by
60%
and
an
overestimation
of
N
Latex
adnase
B
values
by
80%
could
be
observ
Now
Legionella
Urinary
AntigenTest
Kit
(lot
024448)
may
contain
S.
pneumonia
ICT
pouches
devices
instead
of
the
correct
Leg
Stem-trol
control
cell
count
is
out
of
range
higher
from
what
is
stated
on
the
vial
label
after
flow
cytometry
analysis.
/
L’élém
The
product
does
not
meet
specifications.
The
flow
of
urine
up
the
test
strip
does
not
occur
as
specified
on
the
package
inser
Data
demonstrates
an
upward
shift
in
both
control
and
patient
results
of
9-14%
with
a
prediction
of
a
total
shift
upward
of
18
Calstrux used in combination with other products has resulted in a trend in adverse event reports including localized induration,
When
attempting
to
change
the
tube
current
setting
in
the
scan
conditions
from
real
EC
to
a
fixed
value
after
the
scan
start
b
Baxa was notified that specific lots of our exacta-med 1ml oral dispensers may contain a small quantity of dispensers that hav
Two
conditions
have
been
identified
with
the
Philips
Medical
Systems
Brilliance
Big
Bore
version
2.2.1
tumour
localization
tha
Eyelogic system is a class II medical device, and as such, is required to be licenced. Product is not licenced. / Le système Eyelo
Software anomaly in which the flow rate programmed on the console may be changed without automatically updating the flo
Head section load wheel bolts may back out. / Les boulons de la roue porteuse à la tête de la civière sont susceptibles de se d
Frazier and Poole Suction instruments manufactured by ConMed Corp. Between 2001-oct-04 and 2006-oct-04 may have a co
Seven customer inquiries in regard to calibration failures and controls out of range for lot numbers 38005HW00, 41008HW00
Platelet results on patient samples may actually be 10% higher than reported on the cell-dyn ruby and 22% higher than repor
Failure
of
the
ac
inlet
connector
on
REMstar
heated
humidifiers.
A
small
number
of
these
failures
have
resulted
in
thermal
da
A
new
software
version
is
being
released,
which
will
remove
the
2
second
delay
between
the
arterial
master
pump
and
the
ca
There's
a
higher
proportion
of
complaints
associated
with
intermittent
connection
between
a
flat
flex
cable
and
its
connector
A
package
integrity
issue
was
recently
discovered.
This
issue
could
result
in
the
product
being
non-sterile,
which
could
put
pa
An issue on the ie33 ultrasound system with the S12-4 transducer. In recent software versions, both the acoustic output and
A
potential
anomaly
was
identified
on
the
ct
subsystem,
affecting
the
ct
collimator
opening.
/
Une
anomalie
potentielle
a
été
The
125ml
centrifuge
bowl
component
of
the
Uvar
XTS
XT125
photopheresis
procedural
kit
may
leak
blood.
/
Le
carter
de
cen
Manufacturer
has
determined
that
for
these
4
lots
only
the
open
vial
stability
is
only
5
days.
/
Le
fabricant
a
établi
que,
dans
l
Crutches
may
have
incorrect
installation
of
the
rubber
tips
onto
the
bottom
posts,
bolts
used
in
the
crutches
may
be
defectiv
Due to a potential issue with leaking batteries, lifescan is replacing the batteries in affected Onetouch Ultrasmart Metres and
Product put on the market without certification. / Produit mis sur le marché sans homologation.
The
foam
tip
became
detached
from
the
stick
handle
while
oral
cleaning
was
being
performed
on
patients
in
two
separate
fa
Due
to
some
burrs
attached
to
the
blade,
the
placement
of
the
blade
in
the
moulding
tool
did
not
completely
aligned.
During
The
biohazard
bag
component
included
in
these
devices
may
be
defective.
A
customer
reported
that
ice
water
leaked
throug
Toshiba has issued a field modification instruction to update the software to preserve the images acquired. / La société Toshi
Control and sample results may be higher due to the early deterioration of calibration solutions after reconstitution. / Les rés
Product was produced with -7 degree torque rather than correct +7 degree torque. Possibility exists of torquing tooth in opp
Bronze caps on vials containing XiVE 3.0 Dental Implants cracked along bottom circumference of caps. Recall does not affect
BD procount progenitor cell enumeration kit may show poor CD34+ and CD45+ resolution causing bd stem cell controls to fai
Under certain circumstances, the MLC back-up diaphragms of Elekta digital accelerators can move unexpectedly during electr
Incorrect auto-tracking diaphragm values for rectangular applicators and as a consequence, a mistreatment of rectangular elect
Potential
for
non-detection
and
no
alarm
for
upstream
occlusion
with
a
potential
risk
of
non-delivery
therapy,
blood-back-up
During
the
cleaning
cycle,
there
is
a
possibility
for
the
device
to
overheat.
This
occurs
when
the
cycle
is
run
and
the
water
lev
In
rare
cases
the
offline
mode
will
not
activate
as
intented.
/
Dans
de
rares
cas,
l’appareil
ne
s’enclenche
pas
en
mode
hors-lig
It has been confirmed that there is a potentially incomplete seal in the pouch. / Il a été confirmé que la pochette ne soit pas c
Possible excessive speed during deployment of the flat panel positioner, which may lead to injuries to patients. / Il est possib
Event
1:
reports
from
some
customers
of
lost
patient
data,
patient
images,
and
patient
images
mixed
with
files
from
other
pat
Bio-Rad no longer publishes target values and no longer guarantees homocysteine stability for these lots. / Bio-rad ne publie p
Chlamydia trachomatis / potential false negative result. / Chlamydia trachomatis / peut entraîner un résultat faux négatif.
Product
sold
without
a
medical
device
licence.
/
Ce
produit
est
vendu
sans
licence
d’instrument
médical.
The
affected
reagents
(6C25-22
&
6C25-27)
have
the
potential
to
generate
patient
specimen
results
that
are
elevated
by
13%
The
expiry
dating
for
the
device
has
been
reduced
from
2
years
to
1
year
as
small
percentage
of
products
experiencing
a
vacu
In
area
of
extreme
heat
and
humidity,
one
customer
lost
control
of
the
environmental
controls
where
devices
were
stored,
re
The
functionality
"table
tilt"
cannot
be
provided
on
all
system.

Also,
there
is
a
possible
malfunction
in
conjunction
with
activa
Remind
all
customers
of
the
unique
absorption
profile
of
Panacryl
suture.
It
is
essentially
absorbed
over
1.5-2.5
years,
and
the
Disposable
wash
set
bowls
may
not
insert
into
the
centrifuge
of
the
auto-transfusion
machines
causing
the
bowl's
rotating
sea
There
is
the
potential
for
over-infusion
with
all
models
of
the
Alaris
se
pumps
caused
by
key
bounce.
Key
bounce
occurs
when
Some controllers may experience intermittent or permanent display screen blanking associated with partial disconnects at u11 o
Baxter
is
providing
information
regarding
the
use
of
this
device
with
a
secondary
infusion,
potential
for
solutions
from
the
sec
Two
incidents
reported
of
persons
being
impaled
on
the
outer
arm
of
the
u
shaped
hook.
One
in
the
neck,
one
in
the
wrist.
In
When
the
cad
algorithm
fails
(cad
vendors
indicate
that
they
attempt
to
keep
failure
rate
below
1%
of
the
tim)
impax
returns
Optibond
solo
plus
self-etch
primer
and
adhesive
in
chambers
of
affected
lots
were
mis-packaged/mis-labeled
in
reverse.
App
The
entrance
exposure
rate
(EER)
may
exceed
9R/min.
As
published
in
the
Food
and
Drug
Administration
(FDA)
variance
for
m
An
intermittent
leak
may
occur
between
the
aladin
2
cassette
and
the
aisys
anesthesia
pneumatic
interface
(valves).
/
Une
fu
Correction to this recall previously posted on May 29th, 2006. / Correction apporté à ce rappel affiché le 29 mai, 2006.W
Certain
hardware
and
software
components
could
lead
to
unanticipated
device
behaviours.
(Ex.
Initiation
of
a
rapid
stimulatio
Potential
for
missing
segments
on
the
metre
LCD
display,
which
could
cause
blood
glucose
results
to
be
misinterpreted.
/
Des
Manufacturer has identified six issues that may affect these products depending on the version of software being used. / Le f
The grasper jaws broke during laparascopic procedures. / Les pinces à préhension se sont brisées durant la laparoscopie.
During the manufacturing process, some of the files flute blades were damaged. / Pendant la fabrication, certaines des lames
An
error
in
the
format
using
year/month
instead
of
month/year
in
the
expiration
date
embedded
in
the
secondary
bar
code.

Some
units
of
the
total
knee
device
may
contain
faulty
pins
based
in
the
axis
of
the
knee.

Small
cracks
propagate
through
the

Increase
in
number
of
confirmed
complaints
assigned
with
luer
lock-tube
full
or
partial
separations
since
early
2005.
Failure
s
Baxter
will
be
checking
each
instrument
to
ensure
that
all
previously
recommended
corrections
have
been
implemented.
/
Ba
Appearance
was
recorded
as
"white
plug"
during
product
release
but
quality
control
specification
states
"yellow-orange
plug.
Some
of
the
plywood
used
to
manufacturer
the
patient
examination/treat
examination

/treatment
tables
may
have
defects

Over
range
detection
and
correction
feature
does
not
perform
correctly
for
glucose
chemistry
when
"other"
selected
with
so
Potential for a misinterpretation of a system calculation error message when running a digoxin test. / Le message « erreur de
Manufacturer
has
determined
that
some
product
manufactured
in
2005
are
susceptible
to
the
hemostasis
hub
leakingor
sepa
Potential
alarm
failure
to
indicate
the
end
of
infusion
or
occlusion
during
infusion
in
140cc
mode
only.
/
Défaillance
possible
d
GC
America
had
received
information
from
one
of
their
distributors
that
this
firm
was
selling
unlicenced
devices
in
Canada.
/

Notification
and
warning
label
sent
to
users
reminding
to
be
aware
of
the
important
information
in
the
instruction
for
use
suc
Rapidlab 1265 systems may report invalid Co-Oximeter values to an LIS, Rapidlink or Rapidcomm system. / Il est possible que
Vancomycin
reagent
lots
M507219
and
M511327
are
recovering
low.

Although
reagents
met
manufacturing
specifications,
s
Manufacturer
has
identified
the
low-frequency
issue
of
reporting
erroneous
test
results
due
to
the
foil
sealing
occluding
the
p
If
the
product
is
flushed
or
de-clotted
using
45%
ethanol
solution
after
administration
of
infuscate,
the
catheters
may
deterio
Potential
for
higher
than
normally
expected
standardized
uptake
value
(SUV)
for
software
versions
7.2.2
REL
2,
7.2.2
REL
4A,

Kinking
of
the
tubing
during
the
treatment
may
create
a
hazardous
reduction
in
the
cross
section
of
the
tubing
with
harmful
e
Unlicensed devices sold. / Appareils vendus sans licence.
The
blood
&
fluid
warmer
FW600
manufactured
prior
to
April
2004
with
a
front
panel
label
permitted
fluid
to
enter
electrical
The
non-sterile
rear
engaging
pin
can
extend
through
the
cover
of
the
micro
targeting
drive
and
be
exposed
to
the
sterilized
f
If
no
referencing
by
means
of
an
x-rayed
reference
object
is
performed
for
exposures
of
the
PC1,
P2C
and
P10C
made
with
or
Manufacturer
has
become
aware
of
the
potential
for
older
style
"through
hardware"dialysate
monitoring
manifolds
and
"NO
The
tyvek
pouch
containing
the
lens
case,
may
not
be
adequately
sealed.
The
sealed
lens
case
within
the
compromised
outer
Need
to
ensure
that
device
is
tightened
correctly
during
installation
because
if
not
correct,
then
the
rollers
may
detach
from
t
In
the
3D
top
ceiling
supports,
screws
may
become
loose
when
preventative
maintenance
instructions
are
not
followed.
This

Potential
insulation
damage
to
the
heater
wires,
potential
fire
risk.
/
Il
est
possible
que
le
matériel
d’isolation
des
filaments
de
Sale
of
unlicensed
devices.
/
Vente
d’appareils
n’ayant
pas
reçu
de
numéro
d’homologation.
Software
does
not
warn
when
importing
image
files
from
two
different
names
from
patient
names
registered
in
the
leksell
ga
With the software, the cardio pitch for the customized ECG gated protocols (that have been customized and saved before a sc
Potential
for
the
presence
of
a
plastic
strand
at
the
top
of
the
test
strip
vial
that
could
prevent
a
proper
seal
between
the
vial

In
may
Baxter
sent
a
recall
to
all
users
regarding
delay
in
detection
of
downstream
occlusion
and
check
flange
alarm,
Baxter
is
Pouch
could
be
incompletely
sealed
and
sterility
compromised.
All
affected
burrs
found
under
licence#
66832.
Verify
product
There
may
be
damage
to
the
electrical
insulation
caused
during
production,
which
may
present
a
hazard.
/
Il
est
possible
que
Software
can
produce
"out
of
memory"
error.

Acknowledgement
of
error
results
in
printout
of
results
that
do
not
match
run
Manufacturer
has
confirmed
reduced

reaction
rates,
resulting
in
less
sensitivity
to
positive
samples
above
300
mg/ml
and
fals
Test
results
in
quality
control
and
proficiency
survey
may
be
suppressed
by
19%
to
45%
due
to
a
formation
of
a
viscous,
ambe
There
is
possibility
that
the
directions
for
use
(DFU)
found
in
the
EZ
bent
tip
retrieval
sheaths,
may
fall
out
of
the
product
cont
Locking pins may become lose and detach allowing the two parts of the stretcher to detach. / Les tiges de blocage peuvent se
A Single shot of laser energy was emitted from a C6 laser during the 2 minute warm-up period. / Une seule décharge laser a é
If
the
locking
screws
in
the
y/z
slide
are
not
secured
tightly,
the
z
slide
could
move
when
a
force
is
applied.
Instruction
for
use
Cases may contain a blocked pressure vent, which may make it difficult to open the case after a sudden decrease in altitude, wh
Peeling or chipping paint in or around the handle area or cracked plastic in the handle. / Décollement ou écaillage de la peintu
Manufacturer
determined
that
heat
sinking
on
power
board
is
not
operating
as
intended
&
board
may
burn
out,
emitting
smo
Dental
adhesive.
Lot
had
low
concentration
of
light
cure
initiator,
may
result
in
lower
than
expected
bonding.
/
Adhésif
denta
Size
20/04
blades
were
incorrectly
retrieved
by
the
assembly
process
and
misassembled
as
40/04.
/
Les
lames
de
taille
20/04

Testing of x-systems barbiturates ii u control lot 2811Q100, found out of specification results high were observed for the low
Mispackaging of two products. The outer box indicates one product( genesis ii cruciate) but contains the other one (Profix po
It
was
found
that
in
very
rare
instances
the
disposable
set
was
manufactured
improperly
by
inverting
the
input
and
output
co
Possibility
for
a
communication
error
to
occur
between
the
Gammamed
Afterloader
Dev.
and
the
pc
monitoring
console
with
The
outside
diameter
of
the
device
migrated
to
a
larger
than
acceptable
dimension
during
manufacturing
for
it
to
be
able
to
p
Loosening
of
the
rotation
peg
from
the
tibial
base
plate.
/
Désolidarisation
de
la
cheville
rotative
et
de
la
plaque
d’appui
tibial
Since
2006/03/07,
Fresenius
Medical
Care
in
the
us
has
received
69
complaints
which
allege
that
patients
could
not
thread/co
An
error
in
expiration
date
in
secondary
bar
code
which
incorrectly
formatted
using
a
year/month
format
instead
of
month/y
The integrity of the catheter strength may be compromised which could result in breakage upon removal. / La solidité du cath
Possibility
that
protective
tip
caps
on
the
pin(s)
may
comme
off
and
cause
the
pin(s)
to
puncture
the

poly
pouch
package,
the
To
emphasize
to
customer
of
the
special
attention
needed
using
a
coronary
imaging
catheter
in
vessels
with
implanted
stents
 Erroneous results could be reported when the workstation database crashes. / Il est possible que les résultats soient erronés
During
maintenance
it
was
discovered
that
some
of
the
screws
had
loosened.
It
was
reported
that
installation
subcontractors

Access
CEA
may
generate
erroneously
low
CEA
values
after
samples
have
been
frozen.
Product
insert
directs
customers
to
fre
Potential
for
breach
of
sterile
barrier
of
pouch
packaging.
/
Risque
de
rupture
de
la
barrière
stérile
formée
par
le
sac
d’emballa
Change
in
raw
material
resulted
in
a
change
in
performance
of
the
test.

Old
lots
perform
as
specified
with
the
current
metho
Anomaly
in
the
seal
may
lead
to
suture
degradation
and
the
potential
for
a
compromise
in
the
sterility
of
the
product.
/
Une
a
A pattern of premature battery depletion in device manufactured with a single lot of low-voltage, ceramic capacitors was identifie
Device
may
be
difficult
to
unfold
resulting
in
tearing
of
the
non-adherent
layer
which
protects
the
patient
from
the
foam.
/
Le
A
limited
number
of
high-flow
disposable
sets
may
have
been
assembled
with
an
inverted
bubble
trap,
which
may
allow
air
to
Limited batch of straps sewn with 4 layers instead of 3 layers in the loop that attaches the lift strap to the carry bar. / Nombre
These
products
are
not
performing
acceptably
and
may
not
easily
go
into
solution
when
rehydrated
and/or
may
demonstrate
Manufacturer
discovered
this
product
was
labeled
incorrectly
with
the
expiry
date.
/
Le
fabricant
s’est
aperçu
que
la
date
de
p
Customer
bulletin
is
being
issued
since
the
UPRO
SI
unit
(g/l)
was
incorrectly
listed
as
0.1
g/l
in
the
calibrator
package
insert
t
Internal
testing
confirmed
when
running
the
product
in
CBC
selectivity
mode
and
switching
over
to
CBC/diff
selectivity
mode,
Possible
misdiagnosis.
/
Risque
d’erreur
de
diagnostic.

AGA
issued
a
tech
note
dated
January
2,
2006
to
present
facts
and
offer
recommendations
to
mitigate
the
risk
of
complication
The
image
orientation
and
the
orientation
markers(s)
and
annotations
no
longer
match
when
the
fuji
CT
image
processing
alg
Decrease in sensivity of latex A, B, C, D, F and G. / Baisse de sensibilité des latex A,B,C,D,F ET G.
Decrease of the Slidex rota-kit sensitivity might be expressed by falsely negative results for the rotavirus detection in faeces. /
This
action
is
being
taken
because
Bard
Vascular
Peripheral
(BVP)
has
become
aware
of
a
manufacturing
change
that
introduc
Software upgrade to correct problem that programmers will display an incorrect year for "the last program change" date begi
With level 2 of the Quantity control product, lot 78512, negative values have been reported for leucocytes on strips used with
Can cause interpretation to be either false positive or false negative. / Ce système peut donner une interprétation faussemen
Potential
safety
issue
using
the
ILAB
imaging
system
with
ice
intracardiac
imaging
catheters
during
transseptal
puncture
proce
Small percentage of 9fr introducers were shipped to U.S. surgical with 10fr sheats. / Un faible pourcentage des gaines d'introd
Baxter
began
deployment
of
the
pump
to
all
customers
with
many
changes
in
order
to
upgrade
this
device.
/
Afin
d’améliorer
Loss of images, need to repeat the imaging procedure and possibly a short delay in diagnosis. / En cas de perte des images, ré
Potential
failure
mode:
overheating
in
output
stage
field
effect
transistors
and
subsequent
shut
down
of
the
cool-tip
rf
gener
In
some
cases,
a
page
is
missing
from
the
2-page
instructions
for
use.
Some
customers
have
received
two
copies
of
page
2,
an
Potential
for
missing
segments
on
the
metre
LCD
display,
which
could
cause
blood
glucose
results
to
be
misinterpreted.
/
Des
The
tinfoil
in
the
triangle
electrodes
has
the
potential
to
develop
cracks
which
may
hinder
electrical
flow
and
product
perform
During
periodic
package
testing
of
device,
some
failures
were
observed
in
the
packaging
that
potentially
resulted
in
breach
of
The
outermost
pouch
exhibited
wrinkling
and
delamination.
If
this
occurs,
the
integrity
of
the
outer
pouch
could
be
comprom
The
interaction
of
trace
organic
compounds
with
the
diluent/sheath
formulation
may
cause
high
platelet
background
reading
The
patient/exam
selected
and
shown
on
the
radiologist's
console
(i.e.
canvas
page)
may
be
different
than
the
patient/exam

During
in-process
testing
of
XYSTEMS
barbiturates
ii
u
reagent
lot
37648Q100,
out
of
specification
results
low
were
observed
Short
circuit
in
the
table
operation
control
cable
might
cause
an
uncontrolled
table
movement,
which
also
disables
the
touch

An
anomaly
identified
with
big
bore
version
2.0
tumour
localization
application
when
printing
worksheets.
when
first
isocent
Architect
B12
reagent
lots
33079M200
and
33079M201
are
missing
the
30
day
on
board
storage
information
from
their
bar
c
Disengagement
of
the
shrink
tube
from
the
tip
could
occur.

Device
was
used
sterile
and
had
not
been
re-sterilized
or
reproce
A
problem
has
been
detected
in
the
pacs
easy
vision/easy
access
mpr
software,
which
might
lead
to
misplaced
annotations.
/
Potential
problem
with
the
orientation
labels
on
the
post-processing
chart
when
patients
are
imaged
on
their
stomach
(poste
Screw that fix the chair to its bottom may break, causing the chair to topple. / La vis par laquelle la chaise est fixée sur son soc
There
is
a
possibility
of
pin
holes
in
the
sterile
packaging
that
may
affect
the
sterility
of
the
product.
/
L’emballage
stérile
peut

Potential for inaccurate or drifting readings. / Peut générer des mesures inexactes ou déviantes.
A
defect
in
the
heat
exchanger
membrane
could
result
in
perforation
of
the
membrane,
resulting
in
potential
contact
between
This particular lot of EG7+ cartridges could produce an erroneous sodium and/or ionized calcium reading with a patient sample.
A
manufacturing
defect
in
the
bar
electrodes
results
in
not
meeting
impedance
specifications.
The
lower
impedance
may
lead
Kits were misassembled with multidose syringes in place of the single dose syringes. / Les trousses ont été mal assemblées : d
Internal
testing
has
indicated
that
some
glaucome
aqueous
shunts
with
valvues
may
not
function
as
intented.
/
Une
expérime
After
recall
in
2005
(reference
028465)
returned
product
was
placed
on
hold,
the
warehouse
inadvertently
placed
one
lot
num
Potential
problem
with
the
orientation
labels
on
the
post-processing
chart
when
patients
are
imaged
on
their
stomach
(poste
Potential
problem
with
the
orientation
labels
on
the
post-processing
chart
when
patients
are
imaged
on
their
stomach
(poste
An
error
may
occur
where
the
lung
care
program
does
not
store
the
marks
for
measured
modules.
This
service
pack
1
provide
A
user
notification
letter
and
a
mandatory
upgrade
has
been
released
for
the
Allura
FD
10.
There
is
intermittent
and
random

Under
certain
running
conditions,
a
falsely
elevated
result
may
occur
with
the
architect
total
A.HCG
assay
when
architect
B12
When
pumps
are
used
at
low
flow
rates
with
large
volume
syringes,
a
delay
may
occur
in
the
detection
of
downstream
occlus
If the side rails are not pulled far enough and raised, they may get jammed on the upper position. / Si les côtés du lit ne sont p
The reason for the recall is that the 10mm left branch (innominate/brachiocephalic) and the 8mm right branch (left subclavia
Customer
complaints
have
been
received
due
to
abbott
and
non-abbott
controls
out
of
range
high
when
using
the
CK-MB
ass
Failure of the Opto-Triac may lead this component to overheat and to generate smoke. The Opto-Triac needs to be replaced
A
C-Clip
near
the
rasp
connection
end
of
the
instrument
is
being
removed
because
the
c-clip
may
detach
from
the
instrument
Pending
investigation
to
determine
if
modified
Alsever's
solution
lot
#als
10
and
lot
#als
11
could
cause
false
positives
in
sero
There is a low possibility (less than 0.05%) that the primary package blister may have a crack that can cause a loss of sterile in
Manufacturer has found the potential for fluid or air to be passed through the venous line clamp that could cause an air embo
Instability
of
lot
M411138
caused
shifts
with
immage
A1M
lot
M510248.
Calibration
of
Microalbumin,
Urine
Transferrin
or
Ur
Reported problems that the catheter breaks about one inch from the tip. / Les problèmes signalés indiquent que le cathéter se b
This
recall
is
being
initiated
due
to
the
possibility
of
basket
detachment.
Five
US-based
complaints
were
reported
relating
to
b
Manufacturer
has
found
the
potential
for
fluid
or
air
to
be
passed
through
the
venous
line
clamp
that
could
cause
an
air
emb
Ligasure
generator
may
fail
to
recognize
some
ligasure
atlas.
Additionally
there
is
a
remote
potential
of
an
interruption
of
the
Incorrect
setting
of
"automatic
deletion"
rule
and
"auto
transfer"
rule
at
mammoreport
can
result
in
loss
of
images.
/
Le
para
Manufacturer has received reports of failures in the PCA profile and interruptions of therapy in various profiles, Baxter has de
15
boxes
containing
Curix
Ultra
UVL
Plus
were
mislabeled
with
Cronex
10T.
/
15
boîtes
contenant
le
produit
Curix
Ultra
UVL
p
An
increase
in
customer
complaints
has
been
observed
for
failure
to
calibrate
or
inability
to
generate
patient
result
errors.
Cu
Under
certain
conditions,
the
system
software
causes
a
default
value
of
2
ul
to
be
assigned
to
the
calibrator
volume
field
of
th
Lot 25525Q100 was released with concentration values that were low relative to the target for each level. / Le lot 25525Q100
A corruption of the bact/view database could lead to a failure in the transmission of positive results to the laboratory information
Manufacturer has determined that the referenced lots include a liquid activating reagent that is contaminated with Ralstonia
Manufacturer
has
determined
that
this
lot
of
tubes
includes
a
calibration
tube
that
should
not
be
used
to
calibrate
from.
/
Le
Blister
package
of
439
catalog
numbers
and
lots
of
burs
may
not
be
completely
sealed,
thereby
potentially
compromising
the

An
elevated
PO2
measurement
observed
when
running
a
level
2
and
3
quality
controls
on
an
ABL77
analyser
utilizing
a
Calpac
System
alarm
may
occur
in
connection
with
fluid
spillage
and
coolgard
3000
will
enter
standby
mode.
Refer
to
operations
ma
Potential exists for patient to be exposed to an earth-referenced electrical current. / Il existe un risque que le patient soit exp
Performance
does
not
meet
sample
stability
claims.
Samples
stored
at
room
temperature
and
run
24
hr
after
collection
may

Small
percentage
of
units
may
experience
a
delay
in
product
flow
upon
initial
actuation
if
units
remain
in
storage
for
an
exten
A heat dissipator situated on the power supply card could cause it to overheat, release smoke or cause a fire. In this event, th
To
provide
a
summary
and
rate
occurrence
update
for
"Failure
Mode
1"
a

and
"Failure
Mode
2"
and
provide
a
root
cause
for
Variability
in
fabrication
methods
for
the
pressure
sensor
may
affect
the
accuracy
of
pressure
indication.
This
potential
inaccu
Potential
for
broken
pins
in
the
connector
to
disable
the
device.
/
Il
existe
un
risque
que
des
broches
brisées
dans
le
connecte
Component
leads
may
have
intermittent
connection
to
the
printed
circuit
board
assembly
pads.
This
could
lead
to
an
inopera
Printed
circuit
board
assemblies
may
be
contaminated
with
dendrite
growth
and
manifested
itself
as
premature
battery
drain
Following an internal study, it was determined that once open, the product remains stable for a period of 5 days, not 16 days
Two
lots
failed
to
meet
product
performance
expectations
throughout
the
labelled
expiration
period.
Changes
in
the
phospho
Sinking
capability
on
the
power
board
not
operating
as
intended
and
the
power
board
may
cease
to
operate
resulting
in
a
po
Blanket
does
not
release
sufficient
air
pressure,
which
can
cause
an
inner
seal
between
air
channels
to
separate,
causing
a
bu
Device
was
shipped
with
the
incorrect
"instructions
for
use"
(IFU)
in
the
package.
This
error
only
affects
the
"indications
for
u
There have been reports of leakage between the arterial dialyzer connector and tubing for the ready set blood tubing set cod
Sternum
saw
collet
nut
may
not
always
allow
for
an
easy
insertion
of
the
saw
blade
into
the
handpiece.
They
are
used
on
Con
Internal
shipment
tests
indicate,
that
during
shipment
the
blister
may
be
damaged,
potentially
leading
to
unsterility.
/
Des
tes
Image transmission between digitizer and CR QS 3.0.207/CS QS 3.0.210 or ADC QS 2.X.XX/Centricity CR 2.X.XX can fail. Images
Customer
may
receive
visibly
corrupt
images
if
the
ADC
solo
has
been
operated
continuously
for
25
days
without
a
shut
down
Misalignment
of
the
patient
table
may
occur
between
the
patient
table
assembly
and
the
opening
to
the
magnet
bore.
Wher
Software problem with the image navigator (for srs and svs) as well as with the syngo viewing studio when attached via vpn. Na
Image
navigator
software
cut
lines
for
ct
abdomens
are
off
by
2-4cm
on
the
scout
image.
Also,
there
are
problems
with
the
in
Research
population
data
analysis
comments
are
erroneous.
Current
sample
displays
comments
(then
statements)
based
on

If
CXP
analysis
ver
1.1,
2.0,2.1
software
is
installed
on
instrument
already
programmed
with
MXP
Ver
2.0,
the
MXP
software
w
The micro-electrode may continue to advance even when the remote control knob is released. / Il se peut que la micro-électr
Due
to
a
software
error,
use
of
the
measuring
mode
feature
after
alignment
of
the
horizontal
reference
line
will
negate
comp
The
battery
voltage
can
be
interpreted
as
being
below
the
allowable
thresh
hold
to
power
on,
resulting
in
the
device
not
reco
Decay in the activity of alanine aminotranferase, during the lifespan of the lots. / Décroissance de l'activité de l'alanine amino
Failure
of
clamp
barrel
allowed
it
to
rotate
freely
in
any
direction.
Results
in
inaccurate
identification
of
syringe
size.
May
resu
Selected
lots
of
neovisc
are
being
recalled
due
to
reports
of
short-term
pain
and
swelling
in
the
knee
from
some
patients
and
TNCO
notified
Pilling
Weck
that
some
reposable
tips
from
a
particular
lot
were
not
locking
properly
onto
the
handle
of
the
sur
Minor
hydrogen
peroxide
contact
resulting
in
transient
skin
burns
from
customers
using
Sterrad
100s
Systems.
There
is
a
cha
Synchron
systems
ammonia
(AMM)
reagent,
lot
M51219,
may
fail
to
calibrate
with
OCR
high*
errors.
/
Le
lot
M51219
du
réac
Synchron
systems
high
sensitivity
c-reactive
protein
(CRPH)
reagent,
lot
M505223G,
may
generate
recoveries
that
are
falsely
i
When
brainlab
mld
device
is
not
defined
as
varin
mlc,
mlc
plan
export
creates
individual
points/file.
If
exported
to
treatment
s
Supplemental
labelling
info
located
on
the
side
of
product
box
indicates
that
the
size
of
the
stent
is
8mm
x
60mm
instead
of
t
Units
of
measure
may
switch
from
mmol/l
to
mg/dl,
without
prompting
or
iniation
by
the
end
user
and
there
is
a
potential
fo
Manufacturer
has
received
reports
of
delivery
of
unrequested
PCA
due
to
an
electrical
short
in
the
PCA
circuit
simulating
repe
Manufacturer
has
received
reports
of
leaks
from
the
cassette
of
the
disposable
kit
which
have
a
potential
to
create
a
breach
i
Davol
as
received
complaint
records
of
the
pet
recoil
ring
breaking,
which
could
potentially
lead
to
bowel
perforation
and/or

Package
label
indicated
an
expiry
date
of
"2007-06"
instead
of
the
actual
date
of
"2006-07".
/
La
date
de
péremption
mention
Fraser health authority, Burnaby unit in BC have identified the sale of unlicensed ear candles at natural health stores. These a
Potential
reagent
R2
bottle
mismatch
for
the
Elecsys
Troponin
T
product
that
could
potentially
lead
to
a
false
negative
result.
Endoscopy
brushes
are
missing
wax
plugs
which
are
intended
to
prevent
contamination
of
the
brush
with
bacterial
flora
prior
In
house
testing
revealed
the
patient
lift
drive
may
break
causing
the
table
to
fall.
/
Des
tests
internes
ont
révélé
un
risque
de

Package
label
described
the
size
of
the
catheter
as
a
6
fr
where
it
should
be
7
fr.
/
La
taille
du
cathéter
mentionnée
sur
l’étiqu
The
manufacturer
has
become
aware
of
several
events
of
access
pressure
pod
leakage
when
unloading
the
Prisma
sets
from

Product
labelled
latex
free,
but
the
adhesive
tape
used
to
hold
the
2
pole
clamps
together
actually
is
made
from
natural
rubb
Unacceptable level of delamination in lots of proceed surgical mesh manufactured after August 1, 2005. Could result in expos
Vitros
HBsAG
kits
demonstrate
a
higher
than
expected
background
signal
which
could
potentially
cause
some
samples
to
be
i
This
recall
is
being
initiated
due
to
the
possibility
of
basket
detachment.
Five
US-based
complaints
were
reported
relating
to
b
These
specific
protein
assays
are
not
meeting
the
57-day
on
board
stability
claim.
/
Ces
dosages
protéiques
spécifiques
ne
son
Manufacturer
has
discovered
the
potential
for
povidone-iodine
contained
in
peritoneal
dialysis
disconnect
caps
to
be
a
contr
Manufacturer
has
identified
additional
extension
sets
from
a
previous
recall
notification
that
contain
microbore
female
lures

A
Software
anomaly
could
lead
to
misdiagnosis
of
patients.
/
Un
défaut
de
logiciel
pourrait
entraîner
un
mauvais
diagnostic
d
A
formulation
error
has
occurred
in
the
envision
visualization
reagent.
When
used
quantitatively,
it
will
result
in
a
reduction
i
Adapter
with
manufacturing
defects
could
let
ambient
air
enter
the
measuring
chamber.
/
Un
adaptateur
comportant
des
déf
Allon
2001
system
no
longer
heats.

The
defect
was
caused
by
a
wrong
matching
of
the
connectors
that
connected
the
transf
Expired blades were shipped out to distributors. / Des lames chirurgicales périmées ont été expédiées aux distributeurs.
A
quantity
of
30
Coulter
5C
Cell
Control
kit
PN
7547116
lot
100179K
were
mislabeled
as
PN
7547002
lot
10273K.
The
product
Under
certain
conditions
an
incorrect
tube
ID
(barcode)
can
be
displayed
and
printed
on
the
runtime
panel
report
in
CXP
Cyto
It has been found that membrane units of specified lots cause the electrode to exceed performance specifications for drift in
Manufacturer
has
found
an
instability
with
the
inability
to
calibrate,
flagged
results,
imprecision
or
inaccuracy
and
quality
con
Two
capacitors
could
be
installed
incorrectly
on
the
EDA
circuit
board
and
cause
the
injector
system's
EDA
accessory
to
not
re
Reagent
for
this
kit
lot
only
was
manufactured
with
a
raw
material
that
can
interfere
with
Immulite
2000
causing
a
false
eleva
A
cleaner
touched
the
injector
connector
on
an
AD5
table
with
a
wet
cloth
and
got
an
electrical
shock.
The
cleaner
was
not
ha
Voluntary
correction
to
address
a
product
labelling
issue.
The
affected
lot
of
pads
has
the
anterior
pad
label
and
posterior
pad
Manufacturer has determined that the heat sinking on the power board is not operating as intended and the board may burn out
An unauthorized rework of the main circuit board had been performed by the board supplier in 28 instances. Investigation de
Some units of the affected lot have been reported to measure 10mm in diameter instead of the labelled diameter of 12 mm.
Reversed
polarity
of
the
capacitor
in
the
printer
may
cause
overheating
and
possibly
be
a
fire
hazard.
/
La
polarité
inversée
du
The
needle
used
on
some
lots
may
be
blocked
in
the
region
of
the
hub.
/
L’aiguille
de
certains
lots
peut
être
bloquée
au
nivea
Faulty flush device. / Appareil de vidange défectueux.
Baxter
has
identified
additional
issues
such
as
battery
undercharging,
generation
of
false
air
detected
alarm,
gearbox
wear,
u
Reports
of
cracked
welds
in
the
two
piece
shaft
may
lead
to
gantry
collapse
with
gantry
rotation
over
time.
/
On
a
signalé
que
Total
imprecision
when
running
DHEA-S
on
the
DXL

platform
exceeds
product
insert
claims.
/
L’imprécision
totale
des
valeurs
Act
5diff
cp
in
variable
transmission
format
transmits
0.00
for
all
diff
parameters
to
the
host
for
samples
that
are
run
as
cbc
o
Product gives false resistant results. / Le produit donne de faux résultats de résistance.
The software contains a software error that might lead to a repeated pipetting of the same pre-diluted sample into one pre-d
Cartridge
error
1.08,
indicating
a
reference
reading
outside
the
electronic
limits,
may
result
in
clinically
significant
high
readin
Estimated
fetal
weight
result
will
be
incorrect
if
the
operator
fails
to
perform

the
'end
exam'
or
new
patient
registration
step
Some
Vapotherm
devices
are
colonized
by
Ralstonia
SPP.
Source
of
the
contamination
is
not
known.
/
Certains
appareils
Vapo
Manufacturer has identified a situation where the wbc result and the differential may be overestimated and not invalidated,
Some leads of 5 lead cable have been cross connected. / Certaines dérivations du câble à 5 électrodes ont été raccordées tran
The
company
has
become
aware
of
eight
Flextome
cutting
balloon
device
monorail
delivery
system
distal
shaft
separations
in
The
recall
was
initiated
as
a
result
of
a
customer
complaint
indicating
that
some
red
cells
stored
in
the
solution
were
showing
Sixteen
complaints
involving
nine
different
consignees
expressed
issues
with
repetitive
failures
of
the
device
to
successfully
de
Omron
healthcare
inc.
has
received
consumer
complaints
that
the
tip
of
the
thermometer
overheated
during
use.
Consumers
The
owner's
booklet
specifies
that
the
metre
has
a
test
memory
capacity
of
125
records
however,
the
Onetouch
Basic
metre

The microbial load of some vials containing HSV Type 1 monoclonal antibodies in lot 927277 within the kit may not meet man
Boston scientific has identified detachment of the bond between the carrier capsule and the outer sheath on certain lots man
There
is
a
low
possibility
(less
than
0.05%)
that
the
primary
package
blister
may
have
a
crack
that
can
cause
a
loss
of
sterile
in
Manufacturer
has
become
aware
that
B.
Braun
has
initiated
a
recall
of
tearaway
introducer
sheaths
with
cracked
hubs/handle
Communication
as
result
of
clinical
practice
in
which
a
patient
suffered
an
air
embolism
and
subsequently
died,
to
heighten
c
When
two
product
applications
called
flip
and
secondary
capture
are
used
together,
it
is
possible
for
image
orientation
labels
Manufacturer
has
had
reports
of
these
devices
being
occluded
caused
by
inadequate
lubrication
applied
to
the
slit
in
the
upp
Users
may
inadvertently
press
the
on/off
key
instead
of
the
start
key
when
attempting
to
start
the
infusion.
/
Les
utilisateurs

Manufacturer has received complaints of battery swelling, over-heating and excessive discharges and have a potential to com
These
product
codes/lot
numbers
contain
microbore
female
luers
that
may
crack
during
use
and
cause
leakage
of
medication
Manufacturer
has
determined
a
potential
for
air
to
migrate
through
the
silicone
pumping
segment
and
air
could
reach
patien
Baxter
has
received
customer
on
proper
priming
and
for
Baxter's
recommendations
for
intravenous
administration
of
50ml
p
The
inlet
and
outlet
tubing
on
the
cassette
may
be
reversed
on
some
of
the
sets,
which
has
the
potential
to
allow
the
patient'
A
misalignment
of
the
patient
table
may
occur
between
the
patient
table
assembly
and
the
opening
to
the
magnet
bore.
The
To
inform
our
customers
of
a
potential
issue
with
the
breast
biopsy
evaluation
tool
for
calculation
of
the
offset
for
the
aiming
After
installation
of
LX
software
4.5,
pre-existing
user
defined
reagent
(URD)
cannot
be
updated.
/
Après
l’installation
du
logic
Manufacturer
has
determined
that
the
identified
reagent
kit
may
produce
a
false
positive
reading
with
negative
serum
patien
Sterility
of
the
ligating
clips
may
have
become
compromised
by
a
tear
in
the
Absolok
Extra
packaging.
In
2003,
there
was
a
ch
Lot
recalled
due
to
a
lack
of
assurance
of
sterility
at
the
time
of
manufacture.
/
Lot
rappelé
en
raison
de
l’absence
de
garantie
A
manufacturer
investigation
has
determined
that
the
reaction
carousel
rotation
can
be
delayed
if
the
operator
loads
reagent
Manufacturer
has
received
an
increase
in
complaints
of
a
downward
shift
in
control
and/or
patient
results,
folate
concentrati
The L-1-Methylhistidine in the supplement contains a higher concentration that is indicated on the card. / La concentration e
These
products
are
being
recalled
because
there
is
a
potential
for
the
lumen
to
collapse
and
prevent
passage
of
a
guide
wire.
Inoculated
water
blank
is
showing
growth
when
it
should
not.
/
L’échantillon
à
blanc
(eau
inoculée)
montre
des
signes
de
pro
Manufacturer has received reports of a safety mechanism that may rotate too easily making it difficult to activate the safety
Manufacturer is informing customers of changes of reduced stability indicated by quality control results below acceptable ran
Potential for incorrect weight to be displayed. / Il est possible que le poids affiché soit incorrect.
Small
percentage
of
Celite
act
cartridges
have
been
misidentified
by
the
analyser
as
kaolin
act
cartridges.
This
misidentificatio
An
incorrect
WBC
parameter
value
on
assay
sheet
and
impacts
the
WBC
on
the
normal
level
giving
inaccurate
results.
/
La
val
The
manufacturer
has
found
that
when
running
open
tube
mode,
specimen
ID
and
last
name
fields
may
not
auto-clear
after
a
Optical PLT is recovering out of range which is used to process patient samples. / La méthode de numération des plaquettes pa
Manufacturer
has
identified
several
values
in
the
value
sheet
that
are

incorrect
and
may
cause

the
patient
results
to
shift
su
The values for the parameters listed in the table of assigned values are switched, only affects controls resulting in invalid runs
Software anomaly which results in the creation of the wrong protocol. / Anomalie logicielle entraînant la création du mauvais
Manufacturer has determined that this product is showing a decrease in sensitivity of the polymer particles included in the te
Manufacturer
has
found
an
instability
with
the
inability
to
calibrate,
flagged
results,
imprecision
or
inaccuracy
and
quality
con
The
design
of
the
front
stand
is
too
weak
to
withstand
the
forces
introduced
during
use.
The
attachment
can
break
and
lead
t
Reports were received of breaches in the film portion of some of the Endoclamp Aortic Catheters. The sterility of the product
When
performing
synchronized
cardioversion,
using
ECG
monitoring
electrodes
and
multifunction
electrode
pads
or
paddles,
Formulation
error
in
visualization
reagent
(vial
3).
Concentration
of
polyethylene
glycol
was
0.3%,
not
3.0%.
error
may
result

Some hovermatts have been identified as having labels that may be sporadically peeling and/or washing off. / On a identifié c
Possibility
exists
that
the
throttle
spring
could
break,
preventing
the
scooter
from
stopping
upon
release
of
the
throttle
handl
Manufacturer
has
received
complaints
of
near
misdiagnoses
caused
by
artifacts
on
images.
/
Le
fabricant
a
reçu
des
plaintes
s
The
manufacturer
has
identified
two
potential
scenarios
that
may
lead
to
incorrect
values
appearing
on
the
display
screen
of

Decay in the activity of alanine aminotranferase (ALT), during the lifespan of the lots. / Décroissance de l'activité de l'alanine
Decay in the activity of alanine aminotranferase (ALT), during the lifespan of the lots. / Décroissance de l'activité de l'alanine
Inscription de valeur erronée sur le carton du Verical Calibrator Set utilisé avec les réactifs Simplastin HTF et Simplastin L. / In
Manufacturer
has
received
complaints
regarding
depressed
quality
control
results
when
compared
with
previous
lots
and
neg
Product
was
labelled
as
"latex
free"
when
the
adhesive
on
the
tape
used
to
hold
the
two
pole
clamps
together
actually
is
mad
The
overhead
counterpoise
system
II
has
the
potential
to
fall
due
to
failure
of
a
retaining
ring,
which
may
result
in
injury
to
th
The
tips
of
the
cannulae
are
breaking
during
the
mechanical
strength
test.
No
external
customer
complaint
received
regardin
Compromised sterility. / Stérilité compromise.
Some
lot
are
impossible
to
calibrate.
/

Il
est
impossible
d’étalonner
certains
lots.
The
stockyard
does
not
maintain
uniform
internal
temperature
between
2-8
degrees
Celsius
at
warmer
ambient
temperature
Internal
auxiliary
flowmeter
tubing
may
become
disconnected
if
the
auxiliary
oxygen
supply
is
occluded
and
not
obvious
to
th
The sequoia devices may have been manufactured with shot sizes that are below the manufacturing specifications and the un
The
use
of
only
one
battery
module
in
the
servo
I
does
not
always
give
a
reliable
battery
back
up
time.
It
may
happen
that
a
s
Potential exists for the spot phototherapy lite light pipe to not hold its set position and sag and expose the patient to possible
Manufacturer has received complaints that the results of quality control obtained by customers were in the low range of the
Manufacturer
has
received
complaints
of
prolonged
clotting
times
with
freshly
reconstituted
reagent
and/or
shortened
clotti
Potential
risk
for
the
operator
to
be
burned
if
they
touched
an
affected
heat
maintainer
that
overheated
and
deformed
the
d
The set point for the rheumatoid factor has shifted and could increase both patient and quality control values. / Le point de c
Manufacturer
has
had
reports
of
error
codes
919,
920
and
pump
does
not
power
on.
/
Le
fabricant
a
reçu
des
rapports
indiqu
To
inform
customers
about
an
issue
with
the
head
coils.
/
Informer
les
clients
d’un
problème
avec
les
bobines
crânes.
To
ensure
that
all
distributed
Vail
beds
had
retrofit
and
relabelling.
/
S’assurer
que
tous
les
lits
de
marque
Vail
vendus
ont
été
If
software
program
is
terminated
during
a
"save
all"
process,
this
termination
may
cause
the
loss
of
important
data
that
is
ne
Manufacturer
has
confirmed
elevated
results
and
can
have
results
from
samples
with
very
low
or
no
carbamazepine
are
high
If
US
indicate
that
packs
can
be
stored
on
the
analyser
for
up
to
seven
days
but
recent
internal
studies
have
identified
circum
Manufacturer has received reports of positively biased quality control and patient results caused by wells that produced a low
Certain
lot
numbers
have
been
incorrectly
labelled,
one
with
1626WB
and
should
be
1624WB
and
the
other
labelled
as
1624W
Manual
has
been
amended
or
addendums
added
to
confirm
size
of
syringe,
monitor
uptake
of
disinfectant
using
ml
scale
on
b
Vapotherm determined that the company's cleaning procedure may not have been stringent enough to deal with any biofilms
Potential
corruption
of
the
metre's
flash
memory
caused
by
a
flipped
bit.
The
manifested
malfunctions
of
the
flipped
bit
were
The
user
documentation
is
not
clear
regarding
the
total
dose
value
of
a
plan
sum
and
could
result
in
an
overdose.
/
La
docum
A software anomaly which could result in an overdose to non-critical organs. / Une anomalie logicielle pourrait donner lieu à
Dose
calculations
for
ARC
fields
using
the
pencil
beam
convolution
with
the
generalized
Batho
power
law
or
modified
Batho
h
One
test
unit
from
the
affected
lot
did
not
meet
minimum
tensile
strength
requirements.
/
Un
échantillon
du
lot
concerné
s’e
Manufacturer
has
received
complaints
on
a
high
recovery
of

N
SAA
control
SY,
found
in
the
kits
outside
the
confidence
interv
The
package
did
not
have
a
complete
seal
and
could
compromise
the
sterility
of
the
product.
/
L’emballage
n’est
pas
complèt
Initial
investigations
have
identified
dimensional
issues
that
may
result
in
the
jamming
of
the
Uniglide
Femoral
Drill
in
the
Uni
Performance
issues
result
in
a
low
light
output
that
can
create
poor
illumination
of
the
surgical
site.
/
Des
problèmes
de
fonct
Possibility
that
a
defective
PCB
board
in
the
foot
switch
may
cause
the
handpieces
to
self
activate,
run
intermittently
or
rever
Manufacturer
issued
a
letter
to
all
customer
emphasizing
the
importance
in
following
the
directions
for
use.
/
Le
fabricant
a
f
The
two
plates
were
mixed
up
during
the
manufacturing
process
and
may
be
mislabeled
with
the
wrong
identifier.
/
Les
deux
Procedure
'performing
nucleated
red
blood
cell
(nrbc)
quality
control'
in
online
help
may
be
insufficient
for
quality
assurance
The
ventilator
on
some
Fabius
GS
Anesthesia
Systems
failed
due
to
poor
contact
between
the
brushes
and
the
commutator
w
Data
from
internal
testing
indicates
that
there
has
been
a
change
to
the
analytical
sensitivity
from
<1pg/ml
specified
in
the
dir
A
flexible
Teflon
tube
used
to
vent
helium
on
a
Signa
MR
System
had
cracked
due
to
fatigue
and
allowed
helium
to
vent.
/
Un
Two
lots
SW
2779
and
SW
2764
of
Onetouch
Suresoft
Single
Use
Lancing
device
do
not
meet
its
intended
use.
There
is
the
po
Synchron
CX5Pro
Level
Sense
Boards
have
incorrect
capacitor.
Boards
my
fail
prematurely,
resulting
in
level
sense
error
mess
The
engage
screw
may
become
loose.
/
La
vis
d’embrayage
peut
devenir
lâche.
Manufacturer
has
identified
circumstances
in
which
negatively
biased
results
can
be
observed
when
used
for
less
than
28
day
Manufacturer has received complaints of negatively biased results as the system performs an additional dilution. / Le fabrican
The product insert does not contain correct control ranges which were updated on June 24, 2005. / Le feuillet qui accompagn
If
the
modification
made
to
a
plan
affects
the
planning
field's
dose
contribution
to
the
primary
reference
point
the
treatment
Manufacturer
is
warning
all
customers
that
the
elastic
bandage
rolls
containing
dry,
natural
rubber
latex
may
be
mislabeled
in
Internal
testing
showed
that
the
Nichols
advantage
ACTH
cartridge
lot
#
62-404296
may
not
meet
claims
in
the
directional
ins
Units
manufactured
with
wrong
dimensional
tolerance
between
light
guide
post
and
distal
edge
of
telescope's
main
body.
Ma
Decay in the activity of Alanine Aminotranferase, during the lifespan of the lots. / Décroissance de l'activité de l'Alanine Amin
In
micro
culture
resulting
application,
when
user
has
come
off
keyboard,
entry
of
numerical
results
including
comma
will
caus
Archived patient data files may under certain conditions be corrupted upon reopening of the file. / Les fichiers de données ar
Virtual
wedge
importation
using
RTPX
will
appear
in
RTP
column,
not
in
VARIS
column.
Affects
other
wedge
parameters.
No
w
If
symmetric
field
moded
up
when
non-varian
linac
positions
are
asymmetric
&
linac
X1/Y1
jaw
value=1/2
plan
symmetric
val
A
system
lock-up
and
loss
of
images
may
occur
when
repeating
patient
registrations
in
a
specific
workflow.
/
Un
verrouillage

Identification of an anomaly in the software of all the Bact/Alert 3D, 3D COMBI and 3D 60 systems used with Bact/Alert PF bo
A consistent increase in the internal scrap rate (failure mode: broken stent struts) of nitinol stents was observed. / On a obse
Manufacturer
has
had
a
number
of
reports
of
transmural
injections
that
have
gone
unrecognized
at
the
time
of
injection,
coul
Public
advisory
-
user-initiated
change
in
the
units
of
measure
between
mg/dl
and
mmol/l
may
result
in
misinterpretation
of

Two
separate
failure
modes,
each
occurring
at
a
low
rate.
First
mode
F
failure
rate
decreases
with
implant
time
with
no
failur
The
potentiometer
behind
the
joystick
of
the
patient
table
operating
panels
is
connected
via
3
wires
to
the
electronic
board.

Manufacturer
has
found
a
discrepancy
between
the
IGE,
Ferritin
and
STFR
values
for
these
lots
and
could
cause
an
overestim
Smartcycler
DX
has
software
bug
in
"number
of
specimens"
function.
May
cause
incorrect
reporting
of
sample
results.
Proble
The
manufacturer
is
re-emphasizing
the
warnings
in
the
DFUS
to
not
inflate
the
balloons
beyond
15
ATMS
but
will
be
adding
f
Software
introduced
adjustment
to
urine
uric
acid
database
calculation
resulting
in
-2.5mg/dl
shift
in
recovery
for
results
whi
Users
can
overfill
the
supplies
drawer
(aluminium
foiled
alcohol
pads)
which
can
result
in
a
shorting
of
the
DC
adaptor
&
batt
Manufacturer has found a slight change in performance indicated by prolonged APTT results. / Le fabricant a décelé un léger dé
Pointed
end
of
a
screw
securing
the
Occluder
to
the
delivery
wire
could
scrape
off
microscopic
fragments
of
PTFE
plastic
lining
Streck CD-Chex plus CD4 Low required revision of phenotype assay values to optimize the mean recovery for those paramete
Manufacturer
has
confirmed
a
manufacturing
error
that
may
result
in
lower
slope
values
on
new-lot
verification,
shift
in
low
q
Glycohemoglobin
A1c
controls,
levels
1
&
2
(lot
31205)
exhibited
poor
&
inconsistent
chromatogram
quality.
Controls
from
8
Immuno-trol
&
Immuno-trol
low
cells
unable
to
recover
CD19
values
using
Cyto-Stat
CD3
(IGG1)-FITC/B4-RD1
6605015,
CS
B4
Recent studies indicate differences in absorbancy affecting the computation of the concentrations between lots FS2089 or FS
Decrease in D-Dimer values during the life of the lots; only applicable to some methods or devices./ Décroissance des valeurs
Entry of faulty value on the Verical Calibrator Set box used with Simplastin HTF and Simplastin L reagents. / Inscription de vale
7F
introducer
kits
were
inadvertently
packaged
with
8F
introducer
sheaths.The
size
difference
between
the
8F
sheath
tip
and
The
first
broach,
1
point
HEX,
of
the
implant
had
a
shallow
dept
compared
to
the
required
dimension
on
the
drawing
for
the
i
Reported
cracked
hubs/handles
and/or
improper
peeling
of
the
sheath
during
use
in
a
small
percentage
of
product.
/
Le
fabri
A
potential
for
lowered
MICs
with
Nitrofurantoin
(Fd)
when
testing
clinical
Enterobacteriaceae
and
for
out
of
range
quality
co
Packaging
error
-
some
referencell
A1
&
B
kits
inadvertently
packaged
with
panoscreen
package
insert
(insert
code
311-11)
in
The
image
navigator
function
may
not
accurately
display
the
reference
lines
on
CT-Topograms.
/
La
fonction
du
navigateur
d’
Company
had
reports
of
a
tearaway
introducer
sheaths
with
cracked
hubs/handles
and/or
improper
peeling
of
the
sheath
du
Certain lots may have a sidearm that is not properly attached in the handle. Proper fluid flow cannot be ensured with these a
Company
has
received
reports
of
tear-away
introducer
sheaths
with
cracked
hubs/handles
and/or
improper
peeling
of
the
sh
Investigation
has
revewaled
three
different
situations
where
the
x-ray
system
may
not
operate
as
required
by
the
US
21
CFR

Software anomaly during the identification of BPA and BPN bact/alert bottles with generic bar code labels that may cause fals
Implant
may
fracture
at
the
junction
of
the
base
and
the
trabecular
metal
keel
if
adequate
support
for
the
base
has
not
been

Potential
for
failure
mode
leading
to
an
inability
or
intermittent
ability
to
change
the
power
setting
on
the
electro-surgical
ge
Error
occurs
after
performing
a
labelled
measurement
on
a
frozen
waveform
utilizing
a
2d
image
and
an
angle-corrected
pulse
Incorrect
expiration
date
01
Nov
2006,
should
read
11
Jan
2006.
/
La
date
de
péremption
du
1er
novembre
2006
est
inexacte;
The
suction
regulator
incorporates
a
valve
for
turning
the
regulator
on
and
off.
There
is
a
condition
in
a
percentage
of
the
valv
CX
rheumatoid
factor
reagent/calibrator
has
drifted
from
World
Health
Organization
standardization
and
correlation
has
drift
Patient
prothrombin
time
(PT)
may
report
low
for
individuals
on
anticoagulent
therapy.
/
L’appareil
peut
indiquer
un
temps
d
Distal
tip
of
obturator,
lot#
10123,
separated
from
the
proximal
shaft.
A
recent
affected
device
was
found
after
initial
compan
An
anomaly
was
identified
in
the
gemini
ct
image
reconstruction
subsystem
of
the
Gemini
GXL
Pet/CT
System.

This
issue
may
The
immediate
spin
crossmatch
(IS_XM)
assay
performed
on
the
Galileo
may
not
give
the
expected
incompatible
result.
/
L’é
Coolgard
3000
units
manufactured
before
April
12th,
2005,
may
overheat
their
coolant
if
left
in
a
warm
room,
for
prolonged

Synchron
CRP
turbidimetric
assay
may
not
be
sensitive
or
specific
enough
as
a
sole
diagnostic
marker
of
infection
in
neonates
Results will be cleared if the eclipse application is not used during modifications. May lead to incorrect dose distribution and mo
Reagent is past expiry date thus will not produce results since it cannot calibrate successfully. / Le réactif est périmé et, ne pouv
Potassium electrodes may not meet its six month performance life and/or show higher than expected results during calibration p
Reagent may fail calibration with errors. / Le réactif peut être incapable d‟étalonner, ce qui peut entraîner des erreurs.
Retic-c cell control level II vials may have been mislabeled with 5c cell control abnormal I labels. / Les fioles de Retic-C Cell Con
Investigation has found that the design is not capable of functioning under the intended load. / Une enquête a démontré que le m
Complaints received where the clinician could not aspirate (get a blood return on the red lumen of the l-cath 16 gauge product) p
The instruction "autoclave at 121c for 15 minutes" was omitted from the directions section of the label. It was omitted from all la
Reverse assembly of the inlet and outlet lines on the cassette of the administration set can allow backflow of patient's blood into
An internal inspection found a small number of packages with an incomplete seal of the inner foil pouch, which serves as an oxy
A defect in the C.0.0. software allows incorrect measurement results to be entered into the system's built in report. There is no a
Trays were shipped to customers containing lidocaine which have gmp issues in the us, by mistake some of these trays were sh
Manufacturer has received reports that a potential exists for unintentional movement of the elevating base following a mains pow
Modification to the priority of the previous recall for some lots. The ISI is mislabeled and there is a potential for therapeutic conse
The acoustic display of mi (mechanical index) and ti (thermal index) on the HDI 4000 is inaccurate and should not be relied upo
Labeling issue: the isi labeling for simplastin htf on the coag-a-mate max and thrombolyzer instrument platforms is not correct an
Manufacturer is to provide additional information on control value assignments missing from the package inserts. / Le fabricant d
Manufacturer has received reports of the pumps falling off the iv poles due to loose screws and is issuing instructions to conduc
A check flange alarm may occur even though the syringe loaded properly and the infusion cannot be started until the alarm is re
Beds contain linak control box that may be faulty and cause the box to stop functioning and cause the internal circuit board to be
There is potential for the sleep surface pivot bolts to break due to a manufacturing defect of the bolt. This may allow the head s
Becton-Dickinson received reports of leakage associated with the plastic hub of the spinal needles. The leakage condition is as
Some vials of the a1 and b cells for these lots have a hematocrit value between 4% and 6% which is higher than the expected ra
An approximate 15% negative bias between the most recent lot of access cortisol reagent (lot 421265) and previous lots of reag
When the summary report is printed on two or more pages, the first line of the data on page two contains the date and time of th
When used with the colleague pump there is a potential for a non-detection of an upstream occlusion under certain conditions. /
The manufacturer has received reports of decreased reactivity in some vials and there is a risk of false negative results. / Le fab
Device delivers the proper charge, but prints the wrong number on the programmer. / L‟appareil fournit la charge électrique adéq
BD informed cardinal health that they are recalling bd 25 gauge spinal needles because of reports of leakage associated with th
OBI process may allow an inadvertent over-write of planned couch rotations with one couch angle generated by obi, causing los
Onetouch ultra warranty meters from lot#t0407280x and t0502131x allows the end user the ability to change the unit of measure
Beckman Coulter has confirmed that the stockyard does not maintain a uniform internal temperature within 2-8 deg c at warmer
The glue seal between middle housing base and some ultrasound handpieces has been broken, transducer could be dislodged
Misprint of the power-setting symbol on the primary label of the device. / Erreur d‟impression du symbole de réglage d‟intensité s
Software anomaly: if a "get" or "get and delete" is initiated for one voxelq and a "send" is initiated within a short time from the sa
When performing additional ct scans following a whole body pet/ct scan, the ct data set will be misaligned with the initial pet data
End user may inadvertently change the unit of measure and misinterpret meter results. / Par mégarde, l‟utilisateur final pourrait
The central lumen within the basket may not be properly positioned. / La lumière centrale dans le panier n‟est peut être pas plac
The manufacturer received a report from a customer that a continuum infusion pump was attracted to an mr scanner as a result
An error during production of the damon 3 bracket resulted in the lower right cuspid and the lower left cuspid being incorrectly co
When using the flexible implant tube with blind end, part number gm11003730 (included in set gm11004680) the blind end can s
Blanket does not release sufficient air pressure, which can cause an inner seal between air channels to separate, which will cau
Possible mispackaging. The laser etch on the device reflects the correct size but the ox contains an incorrect label. / Conditionn
Manufacturer has determined that certain lots do not possess the physical and handling properties, may be difficult to cut and su
There is a possibility of a screw in the 840 ventilator power supply (part 4-076314-sp) that could work itself loose due to vibration
The threaded hole covers are not locking into the shells correctly. / Les couvercles des ouvertures filetés ne bloquent pas correc
During single patient kit assembly, it was discovered that one of the individual bracket components pulled for the kit had the wro
Manufacturer has received a report about leakage with the plastic hub which is associated with undersized luer taper in the spin
One of the tyvek breather pouches supplied to Medline by Alcan packaging may have an inadequate seal that may cause a com
Manufacturer has received reports of leakage associated with the plastic hub of the needle. / Le fabricant a reçu des rapports co
One component of the GST418 was recalled by the manufacturer, specific lot numbers of the Becton-Dickinson medical 25 gau
Certain lot numbers of the device are being labeled with an incorrect expiry date. / Certains numéros de lot de l‟instrument sont
The live display of the Axiom Artis in the examination room may sporadically stop working. / L‟écran sous tension de l‟Axiom Art
If
pressed
down
off-centre,
the
fluoro
buttons
in
the
power
grip
may
get
stuck
in
the
trigger
position.
/
Si
on
n’appuie
pas
par
Small differences in the tolerances can cause a difference in the tip of the catheter can create differences in balloon detachmen
The purpose of this modification is to replace the gantry belts on the Simview 3000 system. A potential for excessive wear to oc
             Medical Devices RecallsDefinitions
                   Hazard Classification

  Type I, II or III, assigned by Health Products and Food Branch (HPFB or the Branch) to a
ndicate the relative degree of health hazard presented by the product, as follows:
  a reasonable probability that the use of, or exposure to, a product will cause serious adverse
                 health consequences or death.
e of, or exposure to, a product may cause temporary adverse health consequences or where
 robability of serious adverse health consequences is remote, or
se of, or exposure to, a product is not likely to cause any adverse health consequences. Type
  a product which does not have generally recognized or scientifically supported therapeutic
hat avoidance of recognized therapy occurs and where such avoidance could lead to injury or
                               death.

c.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_med_definitions-eng.php




min results for samples that were expected to generate results significantly above the measuring (reportable) range of 0.6 - 19.0 mg/dl. These
 lood Cell Disposable Tubing Sets.Note that COBE Spectra Therapeutic Plasma Exchange Sets has been removed from this recall.
 ill not be replaced. This product is discontinued.
 the frequency of false positive test results for this assay. Siemens believes that false positive results will lead to further investigation, and tha
-6600) lots identified may result in IGFBP-3 levels that are not in agreement with simultaneously measured levels of IGF-1.


 the shaker rod may stop moving. This will affect the suspension of magnetic particles resulting in low RLU values for calibrators, controls &
burns associated with the usage of the Dyonics Bonecutter Electroblade.
ct range for PCO2, blood urea nitrogen (BUN) and glucose for the i-Stat cartridges. Abbott has made the decision to update the affected valu
k of assurance of sterility.
 screpancy with the primary package (blister pack).
based calibrators and controls. The false negative result could pose a patient at risk of not being timely diagnosed for thrombosis and embol
  from the storage stability of 3 days at 2-8c after reconstitution due to instability related to an aging effect.


 s detected during quality assurance. This misalignment was caused by a defective bearing of the collimator.
ron LX instruments may give falsely high results for moderately hemolysed samples.
 ted issues reported on the Intra-Aortic Balloon Pumps (IABP). The display controller assembly, with date code 08_05, was defective and is a
 the lots of Immage BUF1(with Immage Immunochemistry System).
ution is displayed incorrectly. User may misinterpret actual dose delivered if plan is based only on the isodose display.


 deria multivorans. B. multivorans is an opportunistic pathogenic bacteria in compromised individuals, particularly those with cystic fibrosis or
 due to inadequate gluing of the safe connect component to the premold component (cable plug).
 ratio (INR) results. Internal studies have shown that the average bias associated with these lots is 12-16%. Abbott has made the decision to
 l value of unipolar even though box labelling, stated that the nominal value is bipolar.
e packaging of the device to become damaged, potentially compromising the sterility of the product.
 e devices) into the septum of the devices may result in coring and therefore may not perform as intended as non-coring needle.
one of the two compartments fully filled. If a dentist were to apply the product without noticing this, the adhesion performance would be decre
 terilization cycles is 100. The current version of the IFU indicates that the allowed number of sterilization is 25 and is the accurate limit for the
e bias in both controls and potentially patient results with multiple analytes assayed on the Immulite 2000 and/or Immulite 2500. Siemens Hea
 erility of the internal components.
collet to sit flush. The 0.968" slot was only milled to half the needed depth allowing interference with the mating primary posterior stabilized h
ser barcode scanner instead of the intended class I laser device.
 ntain a relay that may not meet Philips performance standards. Possible contamination on the relay surface could compromise its performan
 tilizing the incorrect reference number and consequently without proper registration with Health Canada (unlicenced device). However, there
 errors due to the print quality of the barcode label.
 rsion 3.1. Internal testing has revealed that the analyzer did not dispense plasma following a cancelled microtube due to an error that occurr
 hat different lots of reagent red cells of the same product have been loaded on the analyzer at the same time. This problem only impacts Ort
erile. Boston is not aware of any patient complications resulting from this issue.
 king or breaking and leaking.
 , power supply section, of IEC standard 60601-1, 2nd edition.
ustomer experiences for fracturing cannulas that were from different C0R36 lots as well as from model C0R37.
 nly be resolved by a warm or cold system restart. In exceptional cases the generator is damaged and the system cannot be restarted. As this
 user from delivering defibrillation therapy. This was caused by a manufacturing defect in the paddle switch assembly. This only affects units
epplus 2 systems. The problem is due to the probe prematurely dispensing isoflow prior to arriving at the wash station which may diminish ce
 terial number 400387, referred to as the "Mod F" board) includes a capacitor (C600) that was installed backwards. Affected devices may inte
amples assayed on Access/Access 2 and Unicel DXI platforms when using all lots of Troponin reagent.
nce, the affected cap may not remain in the correct open position on the instrument during pipetting causing the system probe or bead mixer
nce, the affected cap may not remain in the correct open position on the instrument during pipetting causing the system probe or bead mixer
 tt Nutrition which are similar to the ones used in Bausch & Lomb products.
 200 system with the following fixes. Load units/heat units counter in the direct and series technique. Tilt the table up to the end switch. Unexp
 of IND flags associated with the Progesterone Reagent Pack lots identified. Suppressed patient results have also been noted with the Acces
 ms Apolipoprotein B (APOB) reagent lots M908383 and higher when used with Apolipoprotein Calibrator (APO CAL) lots M901536 and M90
 uld potentially cause cable to overheat and to break. If instrument not grounded according to IFU a severe risk of electric shock may result.
 accessories, on the base and/or around the column of the Amsco Surgical Table. This practice can damage the centre column of the table b
  become unintentionally detached from the Urology Extension during use.
a Chemistry 1800 System. If the Versacell is connected to an Advia 1800 Chemistry Analyzer, an incorrect sample tube may be pipetted.
 elled as a heat and moisture exchanger.
 ruber stopper upon removing the metal seal.


 ndle (upper region of the R-tip).
number 666804.
e various product code glass bottles.
ure currents can be 8 - 10ma. Maximum allowed value for enclosure leakage current for single fault condition is 0.5ma according to IEC6060
m, Chemistry 2 Calibrator KC120. An alert message "calibrator insert missing" comes up when scanning the vial barcode for chem 2 cal level


collapse under the weight of the user, which poses a risk of injury from falling from the seat.
ucts. The catalyst may also seem thicker than usual when extruded from the tube.
duce a false positive band in the correct base pair size. This will affect typing results on samples that are DRB1*0401 homozygotes, since th
g a non-suitable extraction instrument.
check valve was assembled backwards which prevents fluid from passing beyond the check valve. There is no opportunity to correct or mod
mpliant with IEC 60601-2-1 with the exception of the radiation leakage at a distance of 2cm from the side of the applicator body in combinatio
e clip, 3)go to exam review or an offline workstation, or 4) measure the zoomed clip, potential risk is that the measured results can be incorre
 5 and 2.10M7 errantly changes the start gantry angle to zero thereby leading to mistreatment of targeted area resulting in no treatment or tre


iochemical reactions with quality control organisms over the shelf life of the product.
o the expiration date stated on the product label.
the following workflow steps 1)zoom in live image, 2)store a retrospective clip, 3)go to exam review or an offline workstation, and measure th
nexpected equivocal or unexpected weak positive reactions for various test wells of hemagglutinaton based assays on the echo.
 result in serious personal injury and damage to the surrounding area.
R) results when using the Architect HAVAB-IGM (LN 6C30) assay. An increase in sample to cut off (S/CO) values has been observed when
esolution SSP Unitrays does not amplify a*2432 allele. This issue would produce a mistyping for a*2432 positive sample.
 rect base pair size of 135BP. The primer mix is designed to detect B*15 alleles. The problem of a weak true positive signal could mean that
lat of the hex.
 In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image. In these cases the patient's diagnos
of wires and overheating of the lamp housing assemblies within the Harmony LA, LC 500 and LA 700 surgical lighting and media systems.
d on the rear frame which could result in breakage when used by consumers above 187 pounds to a maximum of 250 pounds. If breakage o
weld on the rear frame which could result in breakage when used by consumers above 187 pounds to a maximum of 250 pounds. If breakag
 mpromised.
 pneumoniae.
 tes for the Depuy ASR Acetabular Cup System and ASR XL Acetabular Cup System linked to usage of Monoblock Mom Cups with correspo
at was observed with single use rolls recalled (recall number 53073) if used as the primary securement device for dialysis needles or pressu
90504Z and the presence of higher levels of endotoxins was found.
rrect patient identification on report. Both may result in inaccurate or inappropriate treatment.
 rotection hardware that will reduce the risk of breathing circuit heater wire malfunction.
hen applied to magnification images acquired on non-GE digital mammography systems, which could lead to overestimate of size of breast le
orkcell where it has been observed on rare occasions an intermittent low result.
 expiry date is November 29, 2010.
r prior to engagement with bone in the cutting edge, Omnifit HFX, Secur-Fit Max/Secur-Fit Plus Max, and Omnifit Eon Surgical Protocols, as
 ing to occur: A) The last image of a patient study can be stored with the next new patient study performed. B) If the first patient's last image h
ay be breached.
ay be breached.
aration media and in the reported instance was used to isolate stem cells from bone marrow specimens. The isolated cells were placed into
ult in the brake/steer pedal seizing. If the pedal seizes, the braking system may become inoperable and/or steering around corners may bec


 ad may become disengaged and fall.
 size 20, taper .04 (20/.04) and size 20, taper .08 (20/.08) obturators.
 distributed with a lot number deficiency wherein the lot number listed on the packaging does not match the lot number on the individual piec
 discrepancy from the alloying process at another manufacturer. Alloy segregation can affect material strength. It has been suggested that th
h the longitudinal and lateral axes, which could result in patient or operator injury.
utside the US associated with Synex II Implant (Central Body) which fully or partially collapsed in the original implant position after a period o
itivity C-reactive protein adjusters and controls giving an average positive bias of 20% compared with results from previous lots.
 olution Centrifugal Blood Pump that might lead the packaging tray to crack. Cracks in the packaging tray can compromise the product sterilit
 closure of the instrument grip (IS2000 system). A software coding error in P7 caused the error for the MTM grip.
p inlet of the Sarns Disposable Centrifugal Pump during cardiopulmonary bypass.
  2. Severity in risk analysis control document (RAC) scored low leading to less strict supplier inspection and process control requirements.
 some procedures. The cause of this play, is that the hole in the lock washer, which is responsible for locking the accessory to the operating r
 damaged Universal Cable MC5057, used with Conmed Linvatec Electric Handpieces may cause the handpiece to self activate.
 as determined there is a remote possibility that certain handpieces may self activate.
 hat one batch of Impression Coping Closed Tray Nobelactive INT RP Q6x9mm was mis-packaged.
 . Inappropriate handling may cause a crack on the front pivot of the Acrobat 2000 spring arm.
m sample has a higher volume and concentration of beta2-microglobulin, anti-strepolysin o, or immunoglobulin M analytes.


 Engen Laboratory Automation System. When used with TCAutomation software versions 2.8.2 or below, incorrect sample ID‟s may be electr


 ts 09154AE and 09187AA.The test results may be falsely depressed or elevated.


 ste on the receptacle bearing surfaces may increase the force required to rotate the suction manifold. If the force becomes too high the man
packaged with product from lot number 96159DB. In this case, the outer box is labelled with the errant 96158DB lot number while the inner p


 f PTP keypad is pressed while the wavelength window is green, the system may not complete change to new wavelength as requested.
 that the outer pouch seal may be breached.
 inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this were to occur, the MPR may loose its ability to
 tion of an inner pouch having non-sterile outer surfaces into the sterile field. The innermost packaging has been shown to remain intact. Prop
 g was maintained by an inner o-ring seal. The date range of distribution for the affected products is 2007/04/26 to 2007/08/01.
 oducts, the sterile barrier in the packaging (pouch) that contains the vial may be breached.
  130 series surgical light that could cause the surgical light to swing freely. Defect rate is 0.35%.
 Improper storage may cause polymer degradation in portions of the catheter. Use of degraded catheters can expose patients to potential ad


 ge (NAS) or hierarchical storage management (HSM).
 idered a recall under the definition of recall, but is considered a product withdrawal by the manufacturer.
 th modified tip might have an insulation breach and could generate a risk of superficial burn to the patient and/or end-user.
 esult in a less than optimal temperature delivery to the treatment site.
o be erroneously elevated between 17% and 40%.
ble the graphic beam representation and dose display do not agree with the edited field on the text page.
 rdiac option installed below software version 200.0.079.
 of failing Tonometer Prisms is the use of disinfectants not approved and not released by Haag-Streit, mainly cool wipes. This might lead to ir
 range on the label is 5.5 - 10.3 ng/ml/hr. The correct range is 4.0 -7.6 ng/ml/hr.
m some ultrasound systems, the absolute value is not being used.
ngle gate (PW) with steered Doppler angle, the displayed velocity scale is incorrect, which could delay treatment.
 captured' screw. This could cause intra operative confusion due to the mislabeling. The problem originated in 2007 and all internal product w
 be mistreated.
 armers. The inclusion of the recommended and non-recommended proprietary cleaning products supplements the current operating instructi
 theter kink resistance. Penumbra initiated voluntary field removal of the original catheter design from the marketplace.
  with CCAP 1.13 software will not communicate reliably through either channel 3 or 4. This issue only occurs when the monitor's analog outp
 arked indicating the wrong size and part number. The actual 4mm Aimer is marked as 6mm and the actual 6mm Aimer is marked as 4mm.
 ge high results when tested with the control assay.
n used with the current lot of Preciset TDM 1 Calibrator on the Roche/Hitachi analyzers.
d to grow viruses from a patient specimen in order to detect or identify the virus, appeared to also contain another type of cells.
 r due to the potential for the duckbill seal to become dislodged, and a confirmed event in which the seal was retained in a patient.
es Infant Radiant Warmer. The service manual already includes a requirement for an annual check of the power-fail alarm. The test procedu
 are located outside of the standard range.
a report. There were no issues with the acquisition of the data. Users could still acquire data, however there was a requirement to install the
 positive band at the correct base pair size in the presence of A*0301 samples. This will affect typing results on samples that are Aa*0301 ho


 Locking Plate System distal lateral tibial plate) is incorrect. The part was etched as '2357-09-07', when it should have been etched '2357-09
ese products may have a small void in the foil outer package. The void in the foil may lead to suture degradation and the potential for a comp
 r (AER) customers to reinforce the importance of properly setting the disinfectant cycle time when using the ASP AER and to remind users t
O2 without concurrent ECG monitoring and does not identify correct alarms and messages during loss of SPO2 data condition.
 thereby creating a potential to interrupt pump function.
 in the head of the screw. There had been reports of the threaded tip of the inner shaft being left in the screw due to the surgeon being unabl
worn out due to contact with a round aluminum part rotating during the continuous shaking movement, which would result in a warning messa
a loose hub connection, resulting in an inability to obtain the biopsy sample.
and other equipment, which may break x-ray and positioning switches and may not allow exam completion.
 cutaneous leads for spinal cord stimulation of the potential for separation of the titanium insert from the silicone portion of the Titan Anchor,
car-style three point) Steinmann pins. However, they actually contain style 6 (spade-type diamond point).
 range high results when tested with the control assay.
 he moving chair back support and the stationary underside of the armrest.
ot # 32616), based on gram stain results.
utside the US associated with Synex II Implant (Central Body) which fully or partially collapsed in the original implant position after a period of


ment, the upper portion of the abutment had fractured and separated from the lower shaft. The investigation has determined that the product
en the heated plate and the printed circuit board which results in a 'blinking blue light' on the humidifier control knob.
 am, under certain conditions images will be deleted from PACS or from dictated, transcribed or completed status exam.
 tion of one of the robotic manipulator axes differed from the position determined by the robotic controller. Error 103 (karel e-stop detected) a
   the correct version 0719I0166.
e minor burning of the contact point of patients during certain higher energy MRI usage.
d when in fact these components expire 5 years after manufacture. Expiration dating refers to 'use by' dates. There is no risk to patients who
 ode label applied to the product box. The bar code label identified the product as stromatolyser-NR with the same lot number and expiration
rge diameter head) femoral head in certain European markets. Based on Zimmer's investigation, the most probable cause is using a surgica
 rapy, interruption of therapy and fires which may also occur in an oxygen-rich environment.


the Angiotech applied seal is mis-aligned.
ED Phototherapy Systems. When tightened with excessive force, some of these clamps have shown stress fractures or broken. The pole m
 handling of a wash arm dispense plate motion failure. Instead of generating a red 'warning' event and stopping sample processing, the syste
 urgery and was left behind.
n Lantis, e.g. main treatment plan and boost plan. If the cone beam is acquired using calculation of table shift coordinates will be based on IS
odel 94260-19. There is a possibility that the internal power distribution circuit board will fail prematurely, causing the display to go blank. Aud
e especially when the table is in the trendelenburg or anti-trendelenburg position allowing fluids, such as saline or water, to enter the table co
 and "motor rate error" ("MRE") alarm message events with certain Medfusion Syringe Infusion Pumps, models 3010a and 3500 ("pump"). T


on process is maintained through the use of the sensor used in the sterilizer jacket and chamber.
t possible to lock the adapter so it does not properly fixate the frame.
assign the correct time/date stamp for saved files after December 31st 2009. On January 1st 2010, the system date for all SDC HD units wo
y very high D dimer values may be underestimated.
 component of the HiRes 90k cochlear implant (model no. CI-1400-01 and CI-1400-02H) is susceptible to corrosion. The affected units shou
echanism, during surgery or before use. As a result, this could prolong surgery time. Also, if implanted, this could cause a possibility of malpo
been obtained.
 during manufacturing. Lot number 915417 contains reagent RLD in well three and RLC in well four.
d in lot S172057 by about 1.2 seconds.
echo. The result is that the final lot tested will pass QC even though it did not undergo complete QC testing.



 user may observe difficulty in discharging component "A" from the syringe that it is packaged in.
e study preference settings to present colour overlays equivalent to non-pure studies.
e study preference settings to present colour overlays equivalent to non-pure studies.
dium results become elevated as urine specimens are run on a sensor.
 of some sample wheel motion errors when run using 13x100 sample tubes.
on, interruption of or delay in the start of intravenous therapy.
cess. 2. The cable portion is not certified North America. 3. The male plug that plug to the power supply mains is missing a label.
hole, a weakened seal, or an opened seal that could result in the product not being sterile.
garding extended time to reach the proper viscosity (doughy state) and inconsistency or lack of homogeneity during cement preparation, as w
 as the potential to cause a burn if the pod is in direct contact with the patient.
accessory correctly mounted, but with a primary collimator field size setting exceeding outside diameter of that conical collimator. With wrong
'treatment approval enforced' and/or 'allow only couch parameter (vert, long, lat) editing & acquiring for approved plans' selected in treatmen
 system through the BD Q-Syte Luer access split septum. This may lead to complications should the air bubbles not be detected.
h leads to a positive bias of approximately 1ng/ml TG when used in combination with all current lots # 151605, 152737, 155488 and 157297


 X1 jaw should have been moving.
es across the range of the assay. The lot is not stable for the full 30 day period when opened and stored.


ch of sterility could lead to a contamination of the device with subsequent transfer of infectious agents to the patient.
ch of sterility could lead to a contamination of the device with subsequent transfer of infectious agents to the patient.
ay give high eddy currents.
as calculated for the finished device. Cannot assure sterility or function of the guidewire beyond its expiration date.
e table may unintentionally swivel, could result in uncontrolled patient movement during transfer, patient falling to the floor.
at a sample tested at the three month time point had a ph value of 7.70 which exceeded the ph specification range of 6.8 to 7.5 resulting in a
ECNIS 1-Piece IOLS (model ZCB00) have adhered to the lens optic after insertion into the eye. This situation can lead to additional manipul
 ardiac Science Corporation (CSC) may not have received adequate testing prior to being shipped from the factory.
 that contain the individual dressing packages were labelled for Tegaderm Hydrocolloid thin dressing, catalogue # 90022.
 tified as being blank when used in a computer.
  Innex implants.
 e bias of up to 35% for level 1 quality control when calibrated with Chem 3 Calibrator lot 9ED058 vs. 9BD064.
 ographic rod between the column/tube assembly and the spotfilm device.
m‟s expiration date.
 iniensis potentially leading to false ID of isolate.
 ns of stress may have a effect of leakage of the cannula.
cquired in 'plane C' is reversed horizontally.
wered. i-CAT classic containing electrical brake.
1 were packaged and distributed without the instructions for use.
e operation of the bloom DTU-215b cardiac stimulator (not a Johnson & Johnson device) in conjunction with RF generators and EP equipme
stem may result in the gantry-overhead carriage moving below its limits.
 d after August 6, 2008 are misprinted on the right side of the box flap. The misprint incorrectly states "use EDTA whole blood or plasma sam
 R ready-ID assays and subsequent visual interpretation of those reactions are weak positive or questionable (equivocal).
ge compared to the Talar trial implant dimensions.
 odge and/or unravel with minimal force. This could result in having cotton fibres remaining within the urethra during specimen collection of m
 ly impact product package integrity/product sterility.
d on the walkaway instrument. Following the installation of LabPro 3.01 panel update -01 and utilization of the panel type POS combo 33 (PC
 heparin-free samples treated with lot 528752 of Dade Hepzyme when using lot 528752 of Dade Hepzyme with non-Siemens APTT reagents
mers. The inclusion of the recommended and non-recommended proprietary cleaning products supplements the current operating instruction
 tion of one of the robotic manipulator axes differed from the position determined by the robotic controller. Error 103 (karel e-stop detected) a
g in patency failure & potential blood loss where Intro-Flex Introducer secures a venous catheter.
 ting from electromagnetic induction (EMI), electrostatic discharge (ESD), or electro cautery exposure during surgery.
 erator and service manuals. Sys1000 manuals do not specify blood flow accuracy as required by IEC standard.
ent labelling and package inserts state. It complies with European pharmacopeia instead.
a cartridge or suboptimal pouch seal is run, there is a possibility that the performance of the cartridge assays may be impacted.


ulations. The positive bias of approximately 0.3 index units and specimens with 0.5 to 0.8 index may be incorrectly identified as reactive for to
 because functionality of ion chamber ramp comparator with low reference voltage is not reliable.
 use the sensitivity of chloride electrode to be very low and the analyzer rejects calibration.
he possibility of an increased false positive rate in screening programs.
 ualifying process was completed. Because of this, Gyrus ACMI cannot ensure that the product's shelf life will meet the expiration date on the
od when in fact these components expire five years after manufacture.
 ot BNMAX, BNMAY, or BNMAZ using ImmunoCAP Allergen E1. Manufacturer updates information on target range values for one of seven ranges stated
n or attending nurse and lead to increased risk of infection.
 4235, lot no. 687218) was incorrectly packaged with the larger size 06x9mm.
oke inhalation and presence of smoke which can trigger smoke detection alarms.
 t spacer), on a Cell-Dyn 1700, Cell-Dyn 1700cs, or Cell-Dyn 1800 with a die-cast syringe drive may result in diluent leakage during initializati
  during the preparation of the product, it has the potential to cause a leak of contrast material. A leak has the potential to lead to a variety of
  may not be the most recent previous result.
nt Cartridge in that test results may be falsely elevated or depressed, with a variable error magnitude.
 rnal Varian Multileaf Collimator not in Park mode during treatment. The Internal Varian F-Collimator could interfere with the intended conform
e are two screws that attach the cage to the bracket which may fatigue over time and fail causing the cage to become detached from the mou
m is simultaneously operated from the control room and the examination room in the Radrex-i system.
 ll product vials are too tight. In some of those complaints, customers reported breaking or cracking of the glass reagent vial while attempting
 ved adequate testing prior to being shipped from the factory.
of ultrasound. This reduction in ultrasound output is the result of partial loosening of internal glued components within the small black cylindri
se of the drifting Fowler is the Fowler clutch wrapspring having the potential to entangle in between the cup and coupler of the Fowler clutch
e outer blister did not meet the required minimum seal width. (Note: the inner blister seal was not affected).
s Mobile Workstations (WM-NP1, WM-WP1, WM-DP1, WM-SC) can overheat and arc if the fuse carrier is not sufficiently tightened.
 . If the Carendo is not used in compliance with the device instructions for use. Trending has shown a number of events relating to what has b
ing its acquisition criteria for some samples. It only displays the last batch of events acquired.
to the user upon opening of the inner sterile tray.


ity mode" cannot be switched on. Due to a production failure of the manufacturing partner, the distance between the coverglass of the light g
                                           -1109 "assay (X) number (Y) calibration failure, ratio too small for CAL B/CAL A" and /or
1005
CT Total β-hCG Reagent with specified lots:
                                                                                        -
tabular Cup and femoral head packages include labelling and colour coding to prevent mismatch in component size selection. The engraved
 and distinct surgical protocols, one for the Trident PSL Shell (LSP68) and one for the Trident Hemispherical Shell (LSP69) in order to clarify
he HiRes 90K Cochlear Implant (model no. CI-1400-01 and CI-1400-02h). The magnet is designed to be surgically removable if the Cochlear
 assay is being performed with the test file parameters of another assay.
d exam, resulting in those images being displayed erroneously on external DICOM device.
 in passing the spring wire guide through the hub of the catheter or removing the spring wire guide from the catheter.
cet boxes and in the bags in blood glucose meter kits.


2009 have tested positive for a pseudomonas type species of bacteria.
still open on an in-room NX system, a problem of image mis-up can occur on the in-room NX system.
ausing the circuit breaker for the specific electrical outlet to trip.
ally activated for 1215 transducer. 2) In non-cardiac application, can be an error in estimation of velocity when using pulsatility index tool whic
hesis to loosen or completely detach.
or ISI 800 products and the Stellant CT Injection system, the pre-diagnostic protocol must include a transit bolus.2. A defect in SW version 103.0 and 104.0
ellous Bone Screws and Gap Plate Screw, did not comply with metallurgical requirements outlined in the ASTM standards for titanium surgic
as demonstrated poor process control which has raised concerns about the quality of the raw material supplied. As a precaution and due to t
 pump to vent properly. Venting is necessary to equalize the pressure in the reservoir compartment with the surrounding atmosphere. If the v
 rn screening card may occur, which may necessitate a re-screening.
etected because the "active" name of patient is displayed. This affects PCR Eleva system connected to a RIS.
 ulting in loss of communication and patient data.
 and IEC standard. Concerns of increased patient exposure due to leakage of radiation.
sluggishness of CIC Pro, loss of waveforms, parameters & alarming and inconsistent time values.
 isregarded or interleaved based upon their series ID.
ontained a similar part 62-5441 2.0 Compression l Plate Right instead of the 62-5442 part.


 hem by Body Health S.A. were not licensed in accordance with the medical devices regulations.


calibration report. Real time testing in manufacturing indicates the stability claim of 24 months will not be met for lot numbers: M802452, M80
onditions, the noise level in the functional maps may prevent user from clearly seeing a subtle perfusion defect.
 the test kit. An investigation has confirmed microbial contamination in one vial of indicator cell.
 y System, contains a 15g intraosseus needle that is not compatible with the IV extension set that is provided in the module. This may result
ions for use insert on the packaging tube and could render the product non-sterile.
nces of low battery reset between 47 and 56 months, and 1 occurrence of premature elective replacement indicator (ERI) at 54 months post
 achi Tina-quant Apolipoprotein A1 reagent when used on the Roche Hitachi 912 and 917 and MODULAR P systems.
 2 (lots R332037, R332037R and S287001). The protein C chromogenic value is misassigned in these lots and can result in an erroneous pr
es across the range of the assay. The lot is not stable for the full 30 day period when opened and stored at 2-8 c as recommended.


0 OD given in the directions for use.
ustom sterile packs may have been adversely affected as a result of an issue during the packaging process.
ereotactic motion disable function is turned on. This may represent a hazard to a stereotactic patient with a head ring mounted on a floor stan
d after August 6, 2008 are misprinted on the right side of the box flap. The misprint incorrectly states "use EDTA whole blood or plasma sam
atal specimen resulting in a value less than the linear limit. A linear high flag (LH) was therefore not generated. The specimen was known to
 sed, the detector may slide, under the influence of gravity, to its hardware limit.
 e are devices in unit boxes with labels marked size 4 and devices marked '514.0400, size 4', that are actually size 3. For lot KNTK, there are
al needle guides for the stereotactic positioner.
emote probability that a lockup could cause any permanent impairment of the body function or permanent damage to a body structure.
 described in the noted system's operators manual.


ne of the robotic manipulator axes differed from the position determined by the robot controller. This discrepancy caused the CyberKnife Trea
 attached to the alarm to be pinched between the upper and lower case of the SmartMonitor 2 units. If the wire harness is pinched such that
 een reported. The PTFE beading material is a processing aide used during hydrophilic coating. The beading is to be removed followed by a
m without assigning the sample a unique, different, sample ID. As a result, patient sample results may be reported with an incorrect result va
ulations. The positive bias of approximately 0.3 index units and specimens with 0.5 to 0.8 index may be incorrectly identified as reactive for to
iden Kit for use with the LightCycler 2.0 instrument. The factor V Leiden control template may fail to meet the validity criteria set by the macro
headrest adaptors, floorlock retracting to unlock position, CPU errors involving involuntary table movements.
 e can continue to be used, the user might choose not to continue operating the device, causing therapy to be delayed or
ed lateral movement that may impact patient safety.
ellous Bone Screws and Gap Plate Screw, did not comply with metallurgical requirements outlined in the ASTM standards for titanium surgic
 ates audio alarm tones for parameter violation, equipment alerts, or error codes, as well as repetitive beeps to indicate pulses when monitor
ould result in incorrect placement of the K-wire.
 by ignoring the warning message. 3) Specific ESD protection circuitry may result in an over or under infusion. 4) Certain fluids solidify in the
event x-ray generation & image processing. If this occurs, the system cannot be restarted.
x-ray image display. System cannot be recovered without service intervention.
spherical diameter feature was measuring out of specification (oversized).
een the heater plate and the circuit board which results in a blinking blue light on the control knob.
libration of the assigned standard values.
 nd right/left asymmetry, which could subject the patient to additional non-invasive examinations.
 to under-infuse pain medication.
 ve unit (hand piece) after the cleaning process had been completed prior to sterilization.
tion of one of the robotic manipulator axes differed from the position determined by the robotic controller. Error 103 (karel e-stop detected) a
 tip, could cause damage to the inner wall of the blood vessel rendering it unsuitable for bypass graft.
M3-156, may also be affected. These lots are included in Anti-Cardiolipin IGM Test Kit, lot CL-863 only.
ate on some Synchron DXC systems due to an accumulation of crystals.
esent on the surfaces of the femoral head.
 result in misidentification as taphylococcus aureus.
er up which resulted in loss of both visual and secondary alarm enunciation from the LCD flat panel.
 ent # 2 included in the kits.


connected to the integrated power console (IPC) indicating that the hand piece has not been recognized by the console. When this happens
licenced for use in Canada.
atient. Software defect 24578.
PT/INR results. This procedure may include liquid into the meters which can lead to the creation of electrical bridging between heater pins.


ally or completely break at the attachment points. The broken tether may lodge inside the dual swivel tubing or body during shipment to the e
 ads therapy cable (including pads/CPR cable) and the Heartstart MRX Defibrillator/Monitor may wear at an increased rate. Without routine o
e button is released.


 mation may be abnormal, or an error may occur at the time of scan setup when sure exposure 3D is used.
ot interpret the result after 3 minutes". Previously the instructions allowed tests to be read up to 10 minutes.
 sulting in unintentional movement, unintentional radiation, extended radiation or useless image, endangering the patient or opera
o affected facilities but no product return requested.
nfo about sutures separating from catheter.
ng contained no silver. Only a portion of 1 lot did not meet product specifications for silver content.
er) may report "lead impedance: ok" when, in fact, normal wear and trauma has resulted in a short-circuit condition that prevents the lead fro
 of RF interaction and heating up of the coil. This may result in possible burns of the patient. This applies to all Intera 1.5T and Gyroscan Inte
port on the filter was blocked with the plastic mould. Lot numbers listed are the affected anesthesia circuits.
crews may not have the hex broached into the head of the screw, making driver engagement impossible.
sued for packaging. A similar ophthalmic cannula, product 2027 was inadvertently retrieved and packed as a product 4027.
 was wrongly listed under device ID 406636 instead of 406639. Company already have send corrective fax-back to MDB.
 ient monitor. Because of incorrect patient weight and/or height synchronization between anesthesia machine/ventilator and the patient monit
er) may report "lead impedance: ok" when, in fact, normal wear and trauma has resulted in a short-circuit condition that prevents the lead fro


ugh the rad on indicators were active. The treatment was then stopped at around the 4min mark, but the system did not mark the treatment a
 ty feature which prevents customers from opening centrifuge while it is spinning.
 nued. Due to the configuration of the buffer storage in local memory it may not set the status of the future tasks to "done". In this rare instanc
w through Pedicap and may cause ineffective ventilation of patient and inadequate detection of co2 levels, so that the indicator paper will not
he stabilet was the ignition source for the fire.
sound systems and that the formulas determining flow volume are described in the included manual addendum.
 t has been reported that the detached shim may be undetected and be left behind in the patient.



 Conmed Linvatec electric handpieces may cause the handpiece to self activate.
of shielding may result in radiated emissions exceeding CISPR11.
used conical collimator(s) or the failure to mount and verify the correct, intended conical collimator may lead to serious injury or death of the p
erapy interruption and fires which may also occur in an oxygen-rich environment.
ad to leaking and possibly to breakage of the glass barrel.


nd the audible sound is heard and/or the indicator light is on, the foot switch is not functioning properly.
 al tubes were manufactured with an internal diameter slightly smaller than specifications. There is a remote potential for a suction catheter to
e reactions with the positive control observed with this lot.
dible alarms when they are powered by AC or DC power and have no battery or low battery capacity. This also causes a weekly self diagnos


 rts generated will have incorrectly labelled OD (right eye) or OS (left eye).
 ion and false positive rate when run in conjunction (i.e. random access mode) with the Access Accutnl assay.
s been re-established to IFCC reference preparation for plasma proteins, BCD-470. This has caused a shift in quality control results and patie
vary from -3% to +17% with different reagent and calibrator lot combinations when measured against the established gas chromatography fla
d in the main-cabinet.
ode 1006 and error code 1007 and incorrect/elevated results.
 ce of the Immulite 2000 and Immulite 2500 assays. These substrate lots may introduce a shift in both quality control and patient results.
has found that under a very specific set of circumstances, when the display/report screen is configured by the operator, an erroneous result c
xcessive patient blood loss and/or risk of blood-borne pathogen exposure to those in the surrounding area.
entilation at start-up. It occurred within a hospital environment.
 ct out of specs with thread outer diameters.
onents within the affected lots have been identified as having a microscopic crack on the lateral side of the condyle in the posterior chamfer r


 he screws that attach the mounting clip to the hand control case. It is possible that screws without the loctite can work loose and the clip can
with automatic updates from the hospital information system (HIS). This can result in deletion of allergy information.
ules, may not be the most recent previous version.
s crack is located on the bottom of the dish along the stacking ring.
 urnt out on one installation in Australia.
ult in the rupture of the hydraulic hosing causing loss of control of the table surface.
ain the sterile barrier.
 1) lateral axes, 2) bidirectional (longitudinal and lateral) axes, which could injure patient or user.
  from engaging on the stem.
ew partially threaded (part number 00-4840-022-01).
 ation could result in delamination of the inner tyvek seal as the package is opened, complicating removal of the implant from the package wh
her x-ray dose than expected. This issue may pose a risk for patients or users. The potential failure can lead to a radiation exposure rate in e


ent identifiers (PID) are confirmed as valid PID's in Muse Cardiology Information Systems versions 7.0, 7.01, 7.0.2, 7.1 & 7.1.1
 may fail and result in potential loss of monitoring and inability to power up after powering down of CIC Pro.
nd effectiveness was not affected.
e Chart Release C.0 (running on the DC7100 computers of the Intellivue MP700 patient monitor system) can create a second instance of the
use series as marked successfully archived even though the content is saved sporadically with defective pixel or header data.
d under very limited and specific conditions.


 uct is correctly identified, however the product description immediately below is incorrectly stated. The outer box information is correct as we
ose accumulation. If the change to the plan had been to parameters other than dose per fraction, treatment to incorrect volume could result,
 the magnet.
 r scale type and recorder speed may revert back to the factory default settings, which are: USA paper style and 3 cm/min paper speed. This
PRS) while using the dental application v4.0.0 to v4.0.1.9999 on the extended brilliance workspace, the right/left annotations will be reversed
 tion system) live monitor screen, leading the user to believe it was a live dynamic image instead.
 adian electrical requirement CAN/CSA C22.2 no.601.1.
may detach from the stylet.
 rn taps and do not pass the "go" thread plug gage.
nalytical rule (namely car rule) is triggered to block the result.
 sterility) can be adversely affected when exposed to low atmospheric pressure. Syringes are included in kits.
to contain the contaminant over-sulfate chondroitin sulfate (OSCS), which mimics heparin's anticoagulant activity.
l instead of the correct 5.0ml syringe pull.


sult, a recall was issued.
of charging, typically at the abdominal, upper buttock, and less frequently in the subclavicular area.
ange in material without Stryker's approval. The new material has different properties allowing the cannulas to leak.
are leaking while running HM methods.


eflon coated bushings. The bronze bushings may fail due to fatigue.
 t may occur to the drive belts used in the image intensifier and/or x-ray head drive mechanisms.
the welded joint due to excessive grinding may have caused the fatigue failure.


due to calibration factor drift.




cted lots of products. This can impact the clotting time performance with the outcome being longer.
ble by either the Hamilton Star onboard barcode scanner or a hand held scanner.
ctions for use in the package sleeve (packaged with directions for use for anti-a1 lectin).
oiled. The instrument is designed to remain outside the body and should not become heavily soiled.
ng placed in use. Short circuits in the keypad may make pump inoperable or pump may not respond to keystrokes.
es to run until end of its stroke after releasing the push button on hand pendant and then stops.


 adopted into perfusion tubing sets designed for mini-bypass systems for the models and lots specified.
to use the device. It was determined that the difficulty is related to specific manufactured lots.
without depressing the foot switch.
ng manufacturing. Some units which are 12mm thick may be etched and packaged as 14mm thick provisionals and vice versa.
potential affect to the patient may be infection.
 ring an interventional procedure posing an embolic risk to the patient.
 sp2. This only affects systems using the Ximatron simulator. Other simulators (eg. Acuity) are not affected.
d in the folder of another patient. This can be full images but also part images of two patients on one image.
sisted of a scallop feature with twice as many lobes, 24 instead of 12.
ures are a result of transient power surges created from disconnection or intermittent electrical connection.
y result in a missed detection of a HIV type O infection specifically during seroconversion.
 sult in misidentification as staphylococcus aureus.
 2013-13 when it should read 2013-03 (designating March 2013).
 plication to Ransel Kit, RS 504/ RS 505, are incorrect. The current dilution of 1 + 24 is incorrect, it should be 1 + 4.
y syncytial virus, potentially leading to a misdiagnosis of influenza B, thus a recall was issued.
ncorrect and can result in providing inaccurate measurements within the software program.
 was not approved and which causes the device to be considered a class III.
s, causing a short circuit between the board and the chassis.
e incorrectly leading to the possibility of low count errors for patient samples, assay calibrators, QC material.
vised to indicate that NT-proBNP will be stable for 10 days and Troponine I will be stable for 8 days at 2-8 c.


ate specific antigen results at or near the limit of detection.
.e.1 metre). The failed battery may produce a flame or emit smoke. The failure may occur instantly or delayed.
 ay not be accurate. When sonographer unfreezes the image and freezes again, measurements may or may not be accurate.
 phasizing the canopy seal area.
tive copper side instead of the kapton side was incorrectly facing the I/O printed circuit board assembly.
ucts with Durepair is more pronounced than Durepair alone and may increase rates of other known risks.
 obe moved to the rinse station before the operator responded to the user prompt whether the probe was clean.
ostic images to a CD.
 may cause the ECG monitor power cable to be damaged, potential for short circuit, sparks & electric shock.
y. Affects only units in which the replacement CO2 carrier PCB installed between 2005 and 2008 during a repair.
at sealer. They are related to a progressive scratch on the heat plate that caused the voids in some packaging.
nit of measure is pg/ml.
function used to send images for storage on the hard disk.
vice because it is intended for use in diagnosis of disease or in cure, treatment, or prevention of disease.
 lization number. This defect could lead to a patient identification mismatch.
for tensile bond strength and crystallinity.
ase, product met the specifications for reactivity, but upon storage and shipment, reactivity has declined.
arding patient safety on the Artis system.
e systems that may result in sparks.



 ments in the mag 1 or mag 2 X-ray mode for systems manufactured on or after June 10, 2006.


 o other lots.
me being exactly 0.5 seconds which will lead to inspiration phase stopping and ventilation will resume in 5 seconds.
 ightened and could create a potential hazardous situation if the C-arms were to fall.
isplay a whole number, losing decimal point accuracy for low weight patients such as infants.
 bellows system.This could result in an image being displayed with an incorrect phase of the respiratory cycle.
s a save state/save tracking & display incorrect vessel name over restored images. Mismatch of vessel labels.


h communications with other devices and losing the electronic agent level indicator with no alarms given.


 to use the device. Investigation shows that is related to specific manufactured lots.
ces of the tips remaining in the patients.
he monitor even if the accessory is not locked in accessory holder preventing gantry and collimator motion.


ay momentarily produce a flame and then emit smoke. The failure may occur instantly or after short period.
ction image enhancement option made Hippocampus brighter than images taken with the SCIC option off.
 out of the pocket during placement.


ad and is not smooth.
and DxI printed reports when the DxC database is renewed.
 ng the charger 1.0.
moke, a burning smell, and an e-stop condition. This will disable the system rotate motion and all other motions.
 m is set to display blood glucose values in mmol/litre and they are exported for use in another program.
 there is the potential for the supporting cable to become detached from the column causing the column to fall.
 rile barrier. Specifically, the package seal may degrade after sterilization.
oup peritonitis rate.
3D lateral images.
 d energize the mounting bracket, resulting in a noncompliance with regulatory requirements.
m's explicit specifications.
 r may think old study is new one. Patient jacket content may mis-match image displayed.
8000i monitor. Problem occurred when solar 8000i, patient data module and telemetry used in combo mode.
 xPro, 2)VT>2 & PVC(1) when used with solar, dash or eagle (cardiac package software only).
ng design flaw (a missing jumper) which affects samples diluted on board. / Une enquête a révélé que la carte de circuits imprimés de logiqu
apters) that would make the unit unusable because it will not attach to the Mayfield swivel adapter.
he system to overheat and potentially create a hazardous condition inside the system, resulting in smoke and/or fire.
 female metric thread. The metallic tip detached from the shaft upon or prior to using the device.
 ment of the table which cannot be stopped by disconnecting the device from the main power supply.
 e of water. Correct amount of water should be 225ml.
or barcode ID within the same rack. Such duplication could potentially lead to discrepant sample results.
 ere is a possible error (of up to 8mm) in the reported table longitudinal position.
 bber latex while the inner label indicated latex free.The inner label is the correct label.
brator response may be lower than expected for alkaline phosphates for concentrations above 400 u/l.


 exceed the user settable PMAX limit.
 tion in the hemofiltration mode. 2) Deviations in the total fluid loss (TFL) balance alarm.
 and into the wound.


n start timing of the actual scan may be delayed as a result.
 all humeral component. It was determined that the instruction provided could be misinterpreted.
 t being generated when testing some patient samples with lot number 68761HN00.


 d size 4, for the specified lots.
 d size 4, for the specified lots.
 has shown the cause of the low absorbance values to be the biotin buffer.
 ging, which may lead to compromised sterility.
which may lead to compromised sterility which has 30% chance of death as the contamination is on the bloodstream.
 he guidewire grasping and replacement process.
 ill snap MLC leaves back to original aperture. Isocenter shift made in XIO will also cause same.
 ntly when exported to spreadsheet software.
 ssure the sterility of these products.


 nt to fully open the gas circuit due to a defect in the plastics body resulting in absorbent failure.
 acking and leaking of the chamber compromises the sterility of the device raising contamination issues.
s for which sterility cannot be assured, due to a failure in the sterilization process.
 isregarded or interleaved based upon their series ID.
h may result in potential blood exposure and/or blood loss for the patient.
el. / L‟étiquette extérieure sur l‟emballage d‟une tige de 20 mm x 160 mm fabriquée par la société Legion indique qu‟elle est de 10 mm x 160


ternal communications of pump, pump may short circuit due to fluid ingress or compromised insulation.
uct. Post-op failures have resulted in loss of distraction/reduction.
répond pas aux spécifications du devis.
 latch may remain open, even if the tracks are not correctly aligned. / Faible possibilité de mauvais fonctionnement de la gate du système de
 rd are used together, it is possible that a result already present in the request might incorrectly be associated. / Lorsqu‟on recourt à l‟outil co
mbination with the upcoming new lot of tina-quant D-Dimer reagent. / On a signalé une nouvelle attribution des valeurs cibles et de consigne
e that may be susceptible to failure and could cause a short, preventing the AED from powering on. / Certains défibrillateurs automatisés exte
mpliprep Analyzer instead of the vibration damper part intended for this instrument. / Une pièce de l‟amortisseur de vibrations de l‟analyseur C
mériseurs peuvent s‟avérer non fonctionnels pour l‟imagerie panoramique et (ou) céphalométrique de type PSP.
le cas d‟un utilisateur dont les mains ont été écrasées près des montants pneumatiques.
 o administrative oversight. / Le produit n‟est pas autorisé au Canada. B-K Medical a décidé de procéder à un retrait du dispositif en raison d
ere was an increase in the number of reports that the cup separated from the stainless steel tube. / Un changement de procédé peut faire gli
u fil Damon Copper NiTi .014 indique erronément NiTi .016 x .022.
 ts. As a result, the paint on the shrouds has demonstrated the potential to chip. / De la peinture appliquée sur les écrans repeints ne respect
routine calibrator). This will not allow calibrations for both the IO and routine assay on the same instrument. / La carte d‟étalonnage peropéra
 emble se durcir et devenir difficile à extruder.
ding surfaces such as beds, chair armrest or toilet commode chair, could result in detachment from the jib. / On a signalé des cas où les bar
de puissance.
e pump's battery compartment, which cause the pump to temporarily lose power or reboot. / Certains couvercles de compartiment à pile des
 to a potential patient misdiagnosis. / On a observé un affichage incorrect de la date et de l‟heure d‟examen sur l‟écran et le titre du rapport, c
 in the implant procedure, Medtronic has issued updated instructions for use of the lead cap. Depending on the extent of the lead damage an
 result in additional phrases not populating as expected. / Dans certaines circonstances, au moment de la révision du texte d‟un rapport, il s
use. This may create a ramping effect and may allow the arm to fall. / Le circlip peut s‟agrandir pendant l‟installation ou service, ou encore se
extérieur en pellicule d‟aluminium de l‟emballage des plaques du système Lactosorb n‟était pas scellé convenablement.
8 caused reported results to be below actual results. / Dû à une erreur dans la formule de calcul du phénolsulfonate de zinc par la méthode
er drug infusion after an MRI. / L‟exposition au champ magnétique généré au cours d‟une imagerie par résonance magnétique (IRM) peut di
 n. Eg, studies of the merged examinations are sometimes completely or partially not available. / Un dysfonctionnement potentiel en utilisant
tic endoscope reprocessor may leave residual fluids, including disinfectant solution, in the endoscopes. / Une désinfection en profondeur des
operly charge the pump's battery. / Le chargeur externe utilisé avec la pompe V1STA dans le traitement de plaies par pression négative ne r
ion from FA10AUG2007 caused a positive bias of approximately 25% for controls and patient samples. / Le réactif Bilirubine totale qui utilise
ause the pump housing area to be electrically active. Poses a safety issue while the device is being serviced. / La friction exercée pendant le
suture. / Le produit étiqueté comme étant du monofilament nylon noir 3-0 distribué sur le marché est plutôt de la soie tressée traitée noire 4-0
 des résultats faussement négatifs pour la partie du test portant sur l‟EDDP (métabolite de la méthadone).
rature limit of 22C. The requirement for the water temperature prior to pooling is to be within 18C to 22C. / Le lot touché a été fabriqué avec d
 ement part may have sharp edges. / Le vide-ordures pour les déchets solides (DiTi Slide 04J72-29), expédié avec l‟automate M2000SP ou c
eveté appartenant à la classe 2.
 of copper-based material. The coaxial cable is used in the BPX 30 eCoils. / Le conducteur central du câble RG-316 s‟est avéré ferreux et, p
e gradient region may exhibit inaccuracies with the DVH curve and the dose statistics for small structures. / Les plans de traitement du logicie
 des résultats faussement négatifs pour la partie du test portant sur l‟EDDP (métabolite de la méthadone).
 ed with the patient ECG which could lead to images not suitable for diagnosis. / La société a diffusé une mise en garde informant les clients
tic leather cuffs to create a waist belt that restrains the arms of ambulatory patients. / L‟énoncé suivant du mode d‟emploi est inexact : les sa
 ork traffic. / Un virus informatique (networm.win32.padobot.m) infiltrant des processeurs peut engendrer une augmentation du trafic sur le ré
or v1.3.0.1 are installed after non-gyn software version 2.8. This will result in a loss of chain of custody. / Les données sur la disposition du su
dings higher than was actually exposed to the patient using the overhead X-ray tube. Issue2: A software anomaly has been identified. The sl
 tation peut échouer à recharger les piles en raison de divers dysfonctionnements du matériel informatique.
 the sensor's surface. / Le détecteur de niveau ne se connecte pas bien à la surface du réservoir veineux en raison d‟une légère concavité d
ns ATCC 10231 at 20-25 degrees C. / Certains lots de Trypticase Soy Agar (Gélose trypticase de soja) stérile de la société BD Diagnostics p
 incorrect, bottle contains correct influenza B positive control antigen and correct lot number, expiration date. / Les trousses peuvent contenir
 ne to 2 years of use based on the usage and method of operation. / Les pattes du modèle 35-X de la civière PROFlexx de la société Ferno
 revent separation of bend relief from lead. / Le connecteur d‟alimentation percutané du dispositif expérimental HeartMate II doit être remplac
ctif créatinine enzymatique Flex® produit des résultats faussement élevés.
est results identified the discolouration as small discrete corrosion in the form of residue. / Des membres du personnel ont observé une déco
ble initially but increases during the operational life of the sensor. / Une interférence se produit en raison des niveaux élevés de salicylate sur
il 2007) may generate erroneous results in any assay when the instrument is executing the total BHCG P-command. / Les plate-forme Acces
                                                       1-lancement de la nouvelle version 3.20 du logiciel;

elease of a new operation's manual and product label / 
                                                   2-lancement du nouveau porte-s
 in the field. / L‟emballage de deux plaques d‟appui tibiales de taille 3 indique qu‟elles sont de taille 4. L‟une des plaques a été retrouvée, l‟au
e removal, virtual contrast) as well as important corrections for volume perfusion functionalities. / La mise à jour du logiciel, version VE31 / 2
The risk associated with this event includes the rotary knob not functioning. / Le fonctionnement du sélecteur rotatif peut être compromis, ce
existe un risque pour que les pièces à main continuent de fonctionner même lorsque la manette n‟est pas abaissée.
material. / Un lot (170432) de composite de marque Simile étiqueté A2 a été emballé avec du matériel translucide pour les incisives semblab
nix system. / Mise à jour du logiciel vers la version SW 3,35 afin d'améliorer la fiabilité et la sécurité du système Phoenix.
erial of the pivot shaft which retains the cross-piece. / Décrochement de la traverse. La cause initiale de cette défaillance est la contamination
stem, due to entrapment of a pocket of compressed air, preventing tapered walls of cup from engaging with stem. / Au cours de l‟assemblag
al 7.0mm) was packed with plain tracheostomy tubes instead of fenestrated tracheostomy tubes. / Un lot d‟ensemble à trachéotomie Portex
on the map viewer when RF energy is applied. Icon returns to correct position after RF application is stopped. / Une composante de la carte
 Reagent failures of the control is observed. The control is degrading sooner than expected with the cholinesterase. / Lorsque la solution tém
lloon. A lot of the filters had an incorrect luer. The products can be used with and without the filter. / Le filtre fourni ne peut être fixé au cathé
hat in case of an intended joystick deflection, system may perform an unintentional x-ray to patient or user. / Mise à jour sur la sécurité de la m
nsmissions in patients implanted with Consulta CRT-D & Secura DR/VR, & Concerto CRT-D & Virtuoso DR/VR devices. / La configuration lo
ugust 8, 2008 and October 16, 2008 were stored improperly before shipment to Canada. / Certaines boîtes de l‟ensemble d‟étalonnage 10 de
or barcode ids within the same rack. Such duplication could potentially lead to discrepant sample results. / La société Bio-Rad recommande d
ated breathing circuit that maybe more susceptible to malfunction or fire when used beyond specified seven days. / Les ensembles de circuit
nting the loosening of the pivot shaft was missing. / Détachement de la traverse sur le levier au sol de modèle maxi 500. La goupille a ressor
aussement positifs.
ox to come loose exposing the energized electrical contacts within the switch, causing an electrical hazard. / Il existe une possibilité que le c
 ing jelly packets inside the kit. / La date de péremption inscrite sur l‟emballage extérieur des trousses est plus éloignée que la date de pérem
gery. / Risque de fractures du fémur lié au placement des broches percutanées pendant la navigation chirurgicale du genou.
w rate. / Panne prématurée de la pompe péristaltique supérieure. La pompe peut ne pas maintenir un débit suffisant.
 Wallace Oocyte Recovery Sets have damaged needle tips, that may not be detectable on opening the package. / La société Smiths Medica
me. Potential for patient falls or staff injury. / Il peut y avoir des circonstances où la force de freinage de ces lits se détériore avec le temps, c
fficient to prevent tearing or opening of the bag during use. / L‟intégrité du sac qui contient la commande à distance à utiliser dans un environ
eparation of bend relief from lead. / Le connecteur d‟alimentation percutané du dispositif expérimental HeartMate II doit être assorti d‟une tro
o have out of specification (OOS) test results for THC drug concentration. / Les contrôles positifs et négatifs des tests salivaires ainsi que la
ble the front and back jaw potentiometer interlock. No procedure requires the interlock to be disabled. / Dans le panneau d‟étalonnage, il est
ors into the pacemaker headers. These difficulties have been found in a limited amount of lead models and serial numbers. / Notre fournisse
n the Sali-wipes included in the kit. / La date de péremption inscrite sur les étiquettes extérieures du produit est plus tardive que la date de pé
/ Risque d'adhésion déficiente sur la portion étroite du stent pouvant provoquer la séparation de ce dernier.
nt red cell component of the lot 32892 Corqc Test System. / Immucor a reçu des plaintes à l‟effet que l‟élément du réactif du lot 32892 du Co
 the motor's encoder signal is lost, the weight of the system could cause the motion to move further than expected. / Lorsque le mouvement
 when not in use, can cause the motor unit to burn out and melt a localized area of the motor casing. / La carte de circuits imprimés du comm
he Galileo Echo instrument, potentially impacting results. / Le logiciel du Galileo Echo présente une anomalie pouvant provoquer par intermit
p issues affecting an internal circuit board. Failures may be nonrecoverable or may be intermittent in nature. / Les pompes à galet n‟ont pu d
cases resulted in pump stoppage due to grease on the motor encoder. / Les pompes à galets fonctionnent de manière inégale et affichent d
urn speed knob and loss of local control or display. / Les pompes à galet et le module de contrôle centrifuge présentent divers défauts de fon
on has confirmed microbial contamination in some vials of cell#1 of WB Corqc of this lot. / Immucor a reçu des plaintes à l‟effet que certaine
ng displayed with no warning or alarm to notify the user of the failure. / Une erreur logiciel pourrait dans certaines circonstances empêcher de
t" after pump recovers from error code 45 system fault, causing limits to reset to higher factory defaults. / Des limites de perfusion « sur mes
 which may cause the table mount to break during installation or during adjustment of the monitor position. / Des vis de longueur inadéquate
ovement alarm to function correctly. The defect will not allow the caregiver to set these alarms. / Une défectuosité du logiciel peut entraver le
Products Prot Slides. Users are asked to recalibrate their system and current generations of Vitros Prot Slides. / À la suite d‟une enquête inte
separate when the upper arm is fully extended, which may result in a patient fall. / Certains lève-patients font l‟objet d‟un rappel parce que le
ent results may be impacted due to residual sample on the probe causing contamination. / Les systèmes Architect C16000 intégrés à un APS
t is ng/ml. The mislabelling does not impact the diagnostic application of the assay. / L‟unité de mesure pg/ml figurant sur l‟étiquette du Accu
 ormation as displayed is not required for product utility. / Le volume de réactif dans le puits R1B est indiqué comme étant de 4,9 mL alors qu
 ent. / La pointe du tournevis et du limitateur de couple de serrage présente un risque de bris.
 the correct version 0719I0166. / Les clients ont reçu par erreur la version 0719H0166 du guide de l'utilisateur, plutôt que la version 0719I01
and this test contains a rule... this defect could affect patient results and could cause improper diagnosis. / Lorsqu‟un test dont le résultat con
 nt results may be impacted due to residual sample on the probe causing contamination. / Les systèmes Architect C16000 intégrés à un APS
 ay interrupt pump function requiring replacement of pump potentially resulting in serious injury/death. / L‟usure de l‟électrode qui raccorde la
 umen. The leak may contribute to unexpected blood loss during carotid artery repair. / On effectue un rappel de modèles et de lots précis en
 up (preventing use), when the main and the defibrillator microprocessors are unable to synchronize communications. / Un problème de cont
atients sample results due to increased evaporation of the internal standard reagent. / L‟unité de l‟électrode pour ions spécifiques (EIS) du Co
 lost momentarily. A decrease in power (voltage) initiates an E4 error message incorrectly. / L‟appareil Pain Pump 2 Blockaid présente une d
 ed with previous product lots. / Les utilisateurs des lots de ce produit peuvent remarquer une hausse du taux de faux positifs obtenu compar
all (#36749). These units were recalled because the heat exchangers in some sets had a leakage of the inner lumen. / La société Smiths Me
ossible that growth of this bacterial contaminant could mask, or be mistaken for growth from a clinical sample. / Ce lot est contaminé. L‟utilisa
 the functionality "save sets CT", the orientation-labels from the saved images will not correspond to the image. / Un problème est survenu lo
e de la mâchoire.
d record system, sequencer, running Mosaiq version 1.30 and 1.40 with Elekta Icom or Siemens DMIP machines. / Une défectuosité du logi
kapart Probe may result in an unusual signal pattern for abnormal cells. / Après une enquête réalisée à la suite de la plainte d‟un client, il a é
erature display could not track the actual temperature of the basin. / Une plainte d‟un client a confirmé que la température cible du VP 2000 a
 oduct could lead to false or exaggerated indications of resistance to Amoxicillin/Clavulinic Acid. / Le disque peut donner une fausse indicatio
he IFU. Continued use of DR0682M positive control serum could result in a failure of the recommended control procedure. / Le produit peut ê
mers. Some customers have reported an issue where the warmer skin temperature probe measurement can vary up to 2c. / Le fabricant du
n product specs.(i.e. a positive reaction within 1 minute). To minimize inconvenience product is being replaced. / Les réactions obtenues à l‟a
d to support the alara principle when imaging cranial structures. / L‟indice thermique crânien (ITC) n‟est pas affiché dans le cas de l‟examen néonatal de la
 is terminated and the user selects the immediate resumption feature, the beam will be delivered incorrectly. / Dans le cas d‟un plan de traite
s stainless steel/teflon when it is actually propylux. / Le fabricant a découvert que l‟étiquette apposée sur le bloc de coupe avec échelle indiqu
nal wiring of the battery produces a short circuit. / L'enquête a démontré une faible possibilité que le connecteur (partie femelle) et/ou le filage
nsferred to the vaporizer bowl. May also fail to detect an obstruction in door travel path while door is closing. / L‟appareil peut ne pas déceler
due to calibration factor drift. / Certains lots de réactif HDLC3 peuvent entraîner une diminution de la récupération des données du témoin et
 ence range for accepted calibration. / Un lot de solution d‟étalonnage indique le mauvais code à barres, ce qui provoque un déplacement de
re labelled and contained A2. There are no related safety or efficacy issues. / L‟emballage extérieur du Revolution Formula 2 indique par erre
 eneath the pedal can fall out of their mounting, and trigger an unintended motion of the operating table. / En raison du desserrement d‟un pa
 voir des circonstances où la force de freinage se détériore avec le temps.
 and in the bolus summary report, may be less that what was programmed by the user. The amount delivered is correct. / La quantité de bolu
 est possible que les masques ne s‟initialisent pas, par conséquent, ils ne peuvent être utilisés pendant l‟intervention chirurgicale.
Natriuretic Peptide) 1, 2, 3 quality control material shows results drop 20 to 25% in 5 days. / Des plaintes de clients au sujet de la stabilité du
head of the screw. Labelling recall requesting all Synfix technique guides to be discarded and replaced. / Une mauvaise technique opératoire
meeting the storage acceptance criteria of 2-8c for 30 days after reconstitution, or 2 months (aliquot) at -20c. / La société a reçu des plaintes
 product took too long to set. Investigation indicated that there was 2x required amount of inhibitor. / Le matériau à empreinte dentaire, Take
00-10CS and should have been labelled as PMF20-100-10CS/l. / Un lot a été mal étiqueté. Les canules portant le numéro de lot PFFA21110
 he display. After rebooting the system works again. The malfunction is caused by software in the HV generator. / La génératrice haute tensio
grammed post analytical rules cannot be executed when patient results are transmitted manually from analyzer to PSM. / Limites du système
ut du balayage en mode SureStart peut être retardé en raison d'un problème de logiciel.
ed, an error occurs due to a problem of the x-ray exposure control PWB. / À l‟étape de la préparation à la tomographie par ordinateur (augm
 y not fully block emission of electrons. May have a leakage current causing radiation, causing extra patient dose. / Lorsque l‟appareil est utili
 m and could result in slightly rough edge. Follow instructions for use to adequately lubricate during insertion. / La gaine interne en nylon peut
aim published in the CELL-Dyn Ruby system operator's manual for the red blood cell and platelet parameters. / Le système logiciel CELL-DY
mm head. The actual ID of the parts is 28 mm. The deficiency may not be apparent to the user. / L‟emballage et le revêtement intérieur étaien
 , of the Dimension Vista System. Approximately 11% of lot 08198AD is affected. / La société a reçu des plaintes au sujet d‟erreurs d'étalonna
meeting the storage acceptance criteria of 2-8c for 30 days after reconstitution, or 2 months (aliquot) at -20c. / La société a reçu des plaintes
 extrémité métallique s'est détachée de la tige de la sonde (P/N AG5514, lot n° 6120480) au cours de l‟utilisation.
ns of shigella sonnei are unusual and not represented in the knowledge base in the system software. / Des isolats de Shigella sonnei ont été
 ay crash. No movements of stand and table are possible until a geometry restart has been performed. / Lorsqu‟on met l‟angiographie numér
 tential failure can lead to a radiation exposure rate in excess of 11.5/min (as required). / Il peut se produire une défaillance partielle de la gr
d pediatric paddle attachments used with Lifepak 9 and Lifepak 9P defibrillators/monitors. / Des changements sont intervenus dans les méth
g system (APS) centrifuge module (CM) resulting in unexpected failure. New safety measures have been implemented. / Les fissures micros
 t se produire une défaillance partielle de la grille de rotation qui peut entraîner une plus grande libération de rayonnement que prévu.
 ntained in the kit are intended for single use which was not mentioned in the original package. / La trousse a été envoyée aux clients sans m
 the user, there is potential to cause damage to the balloon dilatation catheter during removal of the sheath. / La gaine jaune de protection du
 at increased risk of entrapment. / L‟utilisation de ce type particulier de matelas avec les lits et les traverses Invacare peut exposer les utilisat
 result in a failure to produce respiratory correlated images. / Une fuite entre l‟interface du tube et le tube de sortie du transducteur du systèm
of steps a port may be changed without triggering a calculation & dose distribution is not for the new shape. / Le dispositif XIO est sensé reca
 igh the next day and eventually out of range within a few days. / Des plaintes de clients indiquent que des solutions témoins fraîchement pré
d because the sump tip assembly may separate from the tubing during use. / Plusieurs lots (un au Canada) de canules de drainage DLP Per
 ved contact with starter fluid overflow may cause electrical short. / Des pompes désuètes ont pu être retirées du système et des câbles élec
degrading, causing the release of a small amount of nickel which may cause a sensitization reaction. / Les extrémités en acier inoxydable de
 Plus Software and the user guide. / Le fabricant a constaté un certain nombre d‟inexactitudes de traduction entre la version française du log
 voir des circonstances où la force de freinage se détériore avec le temps.
 y safety stop of the bed motions. / L‟écran tactile situé au pied du lit a affiché l‟erreur « tilt over range » provoquant un arrêt préventif des mo
n a caregiver being unable to hold a patient turn at the desired rate. / Le bouton de garde utilisé pour interrompre le mouvement permettant d
 e close cut-off range, therefore false positive results in the weak positive range cannot be excluded. / La société a reçu des plaintes de clien
 siemens wedges, wedge limits & SAD values for Elekta machines & collimator operating limits for Saturne units. / L‟étiquetage de l‟appareil
ogether with a 3rd party treatment planning system like Adac Pinnacle or CMS XIO can cause patient positioning errors. / Des erreurs de type
antimicrobial susceptibility limitations. Observa user manual is also incomplete. / Les règles par défaut des cartes des systèmes Vitek 2 inclu
bouchon du réservoir pourrait se détacher, ce qui pourrait entraîner une perte de sang.
e. There is no impact to devices quality, effectiveness or performance. / Le produit a été contaminé par de petites quantités de sulfate de cho
ns, le produit n‟est pas assez solide pour l‟utilisation prévue.
nclosed file was laser engraved as a .20 file, but may have been painted as a .25 file. / Le K3 engine file G pack était incorrectement étiqueté
  he treatment approval of a plan. If validation fails, no treatment is approved. Error prevents this correction. / Erreur de logiciel (SW) dans le l
 Commas used instead of decimals for numerical separators with this version 6.6.5042 are not understood properly. / Le logiciel Varis compo
  laxis or Sidexis, the printout shows an incorrect side marker in the form of a white letter L. / Si une vue ceph AP ou ceph PA du volume de G
 r une défaillance possible de certaines caméras 3D
n all instrument platforms. / La stabilité d‟utilisation de tous les ensembles de réactif Elecsys FT3 a été réduite de 8 à 6 semaines sur toutes l
 lot Activator". The information should read "LH Lithium Heparin". / La mention « S Serum Clot Activator » figurant sur les étiquettes préimprim
 l product which is being recalled due to possible defect in manufacturing of component MG300143RL. / La société Source Medical procède
g or higher. / Il est possible que l‟appareil n‟obtienne pas de lecture non invasive de la tension artérielle (NIBP) chez les patients dont la pres
 n advisory to all customers until new cleaning/disinfecting instructions are available. / 1. Les instructions de nettoyage, de désinfection et de
may detach from the stylet. / Il est possible que le protecteur en plastique transparent situé à l‟extrémité du stylet se détache de celui-ci.
 bel. The reagent does contain the correct volume for producing 50 tests. / Le volume pour le puits de conjugué (RLB) figurant sur l‟étiquette extérieure de
 moisture in the indicator may cause the oxygen level reading to be lower than the actual level in the unit. / Dans un petit nombre d‟unités d‟o
  eps, but not used for testing, have a possibility of negative or weaker reactions when used for testing. / Les puits des tests Capture-R Ready
 t testing with capture-R ready screen (3) assays. / Des réactions négatives imprévues se sont produites avec des bandes précédemment uti
  ubjected to the centrifugal forces generated during gantry rotation as well as when gantry rotation is stopped. / L‟unité d‟alimentation de l‟app
  higher than anticipated. The potential result is inability to retract the cannula needle into the cannula body. / L'incidence de la désolidarisatio
greater apparent cross-reactivity to methamphetamine than specified in the package insert. / Il semble que les réactifs des trousses pour le te
 ded in 45 kits was not complete. / Ce produit devrait être accompagné d‟une notice recto verso. Cependant, une notice imprimée d‟un seul c
alysis session screens, pre-treatment run sheets, active medications report (R28) & unverified summary screen. / Les médicaments qui ont u
ong calibration could lead to a measurement error. / La délimitation des contours peut être très faible si l‟image est calibrée avec un cathéter
xact couch. This can cause injury ranging from minor laceration to serious injury. / 1. On risque de se pincer les doigts entre certaines parties
dose values with the current calibrator lot relative to the WHO 2nd International Standard. / L‟étalonnage du test Access HAV AB a dérivé av
  expiration date is printed correctly on the calibration card, the vials and the kit box. / La carte d‟étalonnage du test FT4 Access a la mauvaise
 locate any potentially loose mounting screws. / Vérification de sécurité du tube et du détecteur de l‟appareil Aristos FX. Une inspection visue
 s in the seal, potentially compromising product sterility. / Un petit nombre de sachets de valves des ensembles Attain peuvent être mal scellé
  to display the indices when it should do so. / 2. Le système affiche des valeurs d‟indice mécanique (IM) ou d'indice thermique (IT) incorrecte
  to display the indices when it should do so. / 2. Le système affiche des valeurs d‟indice mécanique (IM) ou d'indice thermique (IT) incorrecte
onder cannot press the shock button to deliver therapy when audibly instructed because it is covered by a plastic lid. / Certains défibrillateurs
  munity requirements. As a result, the DVI Extenders may experience a 5-15 second loss of signal due to EMI. / Les rallonges Ophit DVI (co
y allow shank pin to seat improperly. This could put undue stress on the top screw, which secures shank pin into the corner casting. / La soci
  act pak sterility. / On signale des sceaux faibles ou ouverts sur les emballages de seringues (plateaux). La stérilité du produit pourrait être c
 rather than convex as designed. / La face de la lame a été usinée incorrectement, donnant une lame concave (courbée vers l‟intérieur) plutô
 ts faussement positifs obtenus avec le contrôle externe Giardia ou avec le contrôle négatif externe Xpect Giardia.
s 12.0 and 13.0 (a component of Opengene Software) for Trugene HIV-1 Genotyping. / La société Siemens a reçu des plaintes au sujet des
assed to various degrees across the calibration range, with the high end of the assay showing the greatest bias. / La société a confirmé l‟exis
 sterile integrity cannot be guaranteed. / De grands trous ont été decelés dans le plateau thermoformé de certaines unités présentées dans d
g system (APS) Centrifuge Module (CM) can result in unexpected failure. / Les fissures microscopiques qui se forment dans les godets en m
uld read 266. Only the semi-quantitative method is affected. / 2. La valeur de calibration (CV) 102 imprimée sur l‟étiquette est incorrecte et a
xact couch. This can cause injury ranging from minor laceration to serious injury. / 1. On risque de se pincer les doigts entre certaines parties
er adjustment slopes accompanied by a tendency toward a high bias, indicating product instability. / Durant des tests de contrôle de qualité d
   0.7) and a negative shift in patient values of 20-25% at concentrations > approx. 300 ng/ml. / Une tendance négative sur le plan de la stabili
display to dim and eventually go blank. / Certains défibrillateurs ont été fabriqués avec une composante particulière qui pourrait potentielleme
 s determined that the stain is coming from silicone which is used inside the assembly. / Il y a des plaintes concernant des taches sur les sac
  softpot parameter changes performed in service mode can result in the risk of patient mistreatment. / Aviser que le mode service doit seulem
  r contained information that was not part of the original user manual. / Le fabricant faisait à ses clients un rappel important en matière de ren
  uld read "for postsurgical use following a colostomy or ileostomy procedure". / Mauvais étiquettage – l‟étiquette indique « postopératoire pou
ound absorbance. / La présence de précipité dans le réactif pour la dissociation d‟acide (R1) peut causer une absorption de fond.
  ter and the symbol for length. The symbols on the top of the box and device pouch are correct. / Deux symboles sur le côté et sur les rabats
  ertaines des substances à analyser ou des instruments.
 due to circumstances surrounding the incidents, and not to the filter itself. Recall of all unused units. / Deux déplacements de filtres ont été s
    fell off into the slide waste container below, resulting in a small fire. / Un condensateur défaillant sur le panneau de circuits du processeur d
 nstead of a1 shade. The outer packaging correctly identifies the product and lot information. / Les blocs de fraisage contenus dans l‟emballa
  aced coincident with the identified indications, the area marked is misaligned up to approx. 2 cm. / Le logiciel Selenia V.3.3.1.1 comportait u
  to provide further instructions for disassembly if it attaches to tissue and won't detach from delivery system. / Renforcer les instructions d‟util
ans la contenu de certains flacons.
   to freezing. Below zero the proteins could denature and the control will not give results within specification. / Les deux produits ont gelé dura
he corner(s) of the blister package (tray), thereby potentially compromising the sterility of the devices. / Des lames chirurgicales HallMD de la
ween the abutment and the implant. / La coiffe de cicatrisation ne repose pas complètement sur la plateforme restauratrice de l‟implant, laiss
or rotate freely without motor control. The treatment can proceed with the wrong collimator angle. / La chaîne de transmission du collimateur
 e system. As a result, selected treatment plans will not happen. / Les plans de traitement en arc comportant un collimateur multilame dynam
 ). / Erreur de l‟utilisateur : l‟utilisateur confond (sélectionne) le lavage (touche F6) plutôt que le lavage et la désinfection (touche F8).
n of LOA003, lot# 765295 may have been packaged as LOA002, lot# 765291. / Une partie de LOA002, lot No 765291 pourrait avoir été emb
  erpretations to shift towards more resistant results when an organism has a MIC near the interpretive breakpoints. / La surveillance par bioM
 g plan to be ignored. Such a treatment plan could cause an under dosage of 30% per field (with the smallest wedge). / Une erreur de progra
   fall. / Il y a un risque de bris dans l‟assemblage du dispositif d‟ancrage qui pourrait causer la chute de l‟assemblage du mât ou mât de charg
    ng/ml have been confirmed by internal testing at concentrations between 0.0 and 0.3 ng/ml. / Des cartouches de réactif de certains lots pré
 y features of the Elekta Synergy system. / Une fonction de reconnaissance des empreintes digitales a été ajoutée à la source Elekta Synerg
   / Incapacités occasionnelles de détecter les quantités insuffisantes de solution dans le réservoir de nettoyage 1, ce qui peut avoir une incide
 sable Phaco needles. / Il y a eu une utilisation par inadvertance des symboles « stérile » et « usage unique » sur les directives d‟utilisation de
                                                    with
   distal tip of intrathecal catheters, reported 
 infusion of certain drugs, and to provide patient-care advice. / Pour communiquer aux médec
 ailure. Failure may result in immediate reset of the 
     monitor or shutdown of the device without an alarm. / Le condensateur au tantale a été in
eter mechanism can become "locked" in position and cannot return to the un-contracted, un-deflected state. / Lorsque le cathéter est entièrem
                                                            and
g the valve from the holder at implant more difficult 
 a piece of suture may still be attached to valve. / Un certain nombre de valves ont ét
 autery unit. / L‟interruption du système CentriMag® peut survenir durant l‟utilisation d‟une unité d‟électrochirurgie Valleylab Force FX-CMD.
  rohn's disease contains an error. The (+) and (-) 
     symbols are reversed. / La carte de référence (GMB-0253-01) qui présente l‟algorithme de
with a 3D free hand sweep, which are converted to clips. Should not be allowed due to the inaccurate spatial geometry. / Mesures par recons
 al safety inspection of all mobile OR24 & OR70 magnet types (Harmony and Symphony). / Cette mise à jour définit les mesures d‟inspection
  rners of the blister package, thereby potentially compromising the sterility of the device. / L‟emballage alvéolé de la lame chirurgicale Conme
  e and connector could loosen resulting in loss of contact resulting in unable to start ventilation. / Les vibrations auxquelles est soumis le câb
 orruption of reagent lot memory or failure of QC sample lockout feature may occur. / Une erreur logicielle dans la version 5.02 pourrait avoir
 ry packaging of some devices. A breach in the sterility barrier increases the risk of patient infection. / Un examen rétrospectif d‟études portan
  reduce the likelihood of occurrence. / Révision du logiciel actuel pour corriger le problème lié au retrait excessif de liquide durant le traitemen
  es contained only one part instead of six. / L‟étiquette du produit identifie de façon erronée le nombre de pièces que contient l‟emballage. L‟e
 nerate false negative HCG results. Shelf life of the product can no longer be guaranteed. / Une enquête a indiqué que la sensibilité du réactif
 nine T does not meet the 5 day open vial claim. Troponine T may gradually decrease over the product shelf life. / La société Bio-Rad a noté
nts sterilized in gamma irradiation in air. Following the Health Canada Advisory Notice of October 26, 2007. / Augmentation des tau
 nlock and the back rest falls down. / Le système de crochet et de point d‟ancrage qui maintient la civière Georg Kramer est facile à déverrou
may be a burning smell from within the device. / Un problème avec une composante interne cause une panne du dispositif. Dans certains cas
equipment during the transfer of a patient. In addition, scale calibration is necessary to ensure continued accuracy. / L‟absence d‟un program
ptal instead of Amplatzer PFO. The outer label is correct. / L‟étiquette de la pochette intérieure et celle du dossier du patient pourraient indiqu
  The scatter radiation was confirmed to be 1.2 to 3 times higher that stated in the original operator manual. / La présente fait suite à une plain
ples during in-house testing using incubation procedure A (40 degrees C. for 2 hours). / Le produit a comporté un nombre plus grand qu‟esco
rms were enabled when the Suresigns VS3 Vital Signs Monitor was not in interval non-invasive blood pressure (NBP) mode. / Il est possible
 lit apart and emit an unpleasant odour. / Si on échappe par terre le glycomètre ou la pile, il est possible que par la suite la pile surchauffe, qu
hereby compromise products sterility yet product is labelled as sterile. / Le sceau de stérilité de certaines trousses de stabilisation du poignet
   Further investigation determined the linearity of the lots is decreasing over shelf life. / Le contrôle de la qualité interne a confirmé que la liné
 d in a metal container, manufactured from self extinguishing materials and cannot catch fire, only melt components. / L‟unité de conditionnem
 ed images from the cardiac viewer or pulmonary viewer, and then views them in the CT viewer, measurements are incorrect. / Lorsque l‟opé
g mid-life (24-48 mo) even though batt. Volt. (>2.65v) and capacity remain available. Behaviour caused by high battery impedance. / Le fabric
  d to voluntarily place finger inside a 3/4 in. hole and into the internal 3/8 in. slot which rotates when bar is released. / Le doigt d‟un jeune enfa
nt. / Les ostéotomes de marque Epker ne comportent pas les gravures au laser sur la partie mobile de l‟instrument.
d on the Elecsys instruments. / Le fabricant a établi que la stabilité du produit est limitée à 3 semaines lorsque celui-ci est conservé dans le d
 pension system in which the J-blow tubing has cracked. In some cases, this failure has caused the J-bow to fall. / Le service de gestion des
e DH become loose. In some cases, this may cause the screws to back out or shear off causing the j-blow to fall. / Les vis retenant la pince M
 yse A2 hemoglobins using a program intended for A1C glycated hemoglobin. / La défectuosité de la carte est telle que le programme ne pou
complaints of weakened reactivity or false negative reactions for positive controls. / Cinq lots de réactifs Anti-S pour la détermination des gro
% CDT for the affected lot numbers. / Le fabricant a déterminé qu‟un biais négatif, allant jusqu‟à des valeurs inférieures de 20 %, peut être ob
 ot was assembled with an incorrect suture configuration. This could potentially result in a loose repair. / Il a été signalé que les produits comp
ng use. / Un filament macroscopique pourrait se déloger de l‟assemblage et possiblement pénétrer la circulation sanguine durant l‟utilisation
 nd allow upper deck to collapse to lowest position. Caster brakes can be fractured if bed is moved. / Le matériel du mécanisme position hau
h U Plus cannot be met. Stability of bicarbonate in reconstituted control:1 day in closed bottle (instead of 2). / Tel qu‟allégué, la stabilité du bic
 nd of the package (flat pouch) for the individual unit may not have been applied. / Certains sachets stériles utilisés pour le transport des supp
 lot. The value is labelled as 3.2 MEQ/L but should be 3.7 MEQ/L. / On a découvert qu‟une valeur d‟étalonnage erronée pour le magnésium C
 rements at the Syngo dynamics workplace, the VMAX that is derived is incorrect. / Les clients qui utilisent le dispositif de calcul cardiaque de
 p) and/or failure of the ventilator to alarm (inaudible, intermittent or distorted alarm). / Un dysfonctionnement de la carte de circuits imprimés
  tery may not charge properly. / Un défaut de l‟adaptateur de courant peut provoquer une perte intermittente du contact dans le connecteur e
nary structure might wear out over time which could lead to tilt of the door and possible injury to operator. / Des lettres de mise en garde ont é
  TA blood collection devices and a positive bias as high as 7.9 mg/l at C-reactive protein concentration below 3.0 mg/l. / Le fabricant a confirm
to be a significant change and the licence had not been amended. / Le blindage du capteur n‟est plus fabriqué avec le matériau original. Ce c
  t from growth seen on accompanying chocolate plate. / Il y a un risque d‟échec de la croissance de Haemophilus influenza. L‟absence de cr
 The new values may require the user to increase the level of shielding currently surrounding the I-Cat machine. / L‟information relative à la d
 s which may potentially be present in some sterile packages. / La société effectue un rappel d‟ensembles sur mesure comprenant une comp
 t due to an issue with the software. / Il est possible que le numéro d‟identification et le nom d‟un patient soient apposés sur des images prove
hes dans les trous antérieurs peut causer de l‟interférence au moment de l‟utilisation de l‟emporte-pièce.
 ducts. / On a rapporté des plaintes de consommateurs relatives à des irritations cutanées et à des brûlures lors de l‟utilisation de produits BD
n incomplete staple line. / La société a découvert un problème lié à la fabrication d‟une composante susceptible de faire en sorte que la carto
  noted in cm. Cat number and dimensions of product correspond correctly. / Les renseignements sur l‟étiquette donnent la longueur de l‟enro
x (TI) values, or might fail to display the indices when it should do so. / Dans certaines conditions, le système n‟affiche pas les bonnes valeur
ne mauvaise installation de la tubulure est susceptible d‟entraîner des blessures graves ou la mort.
  to premature mechanical failure of the oil mist filter. There is no impact on requirements to achieve sterility. / Le fabricant a reçu des rapport
o the internal handles/paddles. If former, patient infection could result. If latter, defibrillation therapy may fail. / Les méthodes de stérilisation d
R introducer assembly. The introducer assembly does not contain the side arm, dust cap and dilator. / L‟ensemble 6 FR permettant l‟introduc
  art number 3009376-004 NI-CD batteries with 2.4 amp/hour capacity. The batteries are still fully functional. / Un fournisseur a étiqueté par er
 y features of the Elekta Synergy system. / Une fonction de reconnaissance des empreintes digitales a été ajoutée à la source Elekta Synerg
her no instructions for use (IFU) or the incorrect us version of the IFU for the HV-R bone cement device. / En raison d‟une erreur de condition
 n which abnormal analysis results may be obtained when using the cerebral blood flow analysis function. / Dans le tomodensitomètre Aquillio
  ation includes a data table that lists the record ID and numerical results mapping for result records for each test results transfer message, e
er support band should fail, the safety switch should activate, prevent table rotation and send an error message to the operator console for se
plates have been found to yield sporadically lower optical density values on some, but not all, Elisa plates. / Une enquête interne indique qu‟il
 the picture for diagnosis of hepatitis caused by other etiologies. / Possibilité d‟obtenir des résultats faussement positifs en employant le systè
e use device intended to hold reusable fluid level sensor in place on side of reservoir of extra corporeal circuit. / Les coussinets de détection d
LAL) as a manufacturing release test. / Certains lots d‟ensembles de sacs destinés au traitement du sang (8_5101) n‟ont pas subi, en tant qu
 ncorrectly if the patient is scanned in orientations other than supine head first. / Les images produites à l‟aide de la fonction de reconstruction
   When weight is edited, old beam weight is displayed while dose distribution reflects edited beam weight. / Il y a un bogue dans le logiciel du
c Test System. / Immucor a reçu des plaintes à l‟effet que certains lots du corQC Test System présentaient une hémolyse importante ou une
ersion 2.0.9 or lower. / Dans de rares cas, il est impossible d'activer le mode hors ligne tel que prévu pour les instruments équipés de la vers
  ome lots of carmeda-coated cardiopulmonary bypass products, including Affinity NT Hollow Fiber Oxygenator with CBAS. / Deux lots d‟hépa
  uld pose a risk of hemodialysis to patient. / Possibilité d‟occlusion (partielle ou totale) du connecteur artériel (rouge) au dialyseur, ce qui pou
  and be unable to store images correctly. / Il est possible qu'un échec de formatage (format failure) du disque dur de certains appareils OEC
  or "sample not seen-turn off-try again".potential that low INR result may be displayed instead of error message. / Plus grande fréquence d‟a
bration issue that causes lower-than-typical signal during calibration with CTNI testpaks (CCTNI). / Certains lots de Cardiac Troponin I (cTnI)
 justing vertical motion, following which, the table's vertical motion locks up. / Certaines tables Omega risquent de descendre de manière inat
  hether the PET is opened alone or whether the PET is participating in a fusion with a CT. / On a signalé que l‟outil SUV donne différentes va
adequate visibility of the urethral structures during surgery. / Les fibres du dispositif urétral (Urethral kit) sont susceptibles de ne pas s‟illumin
ontouring is activated on smart handle or smart box, the capacitive sensors may not detect small objects. / Des erreurs de mesure peuvent s
 f the centre was to become loose/come out of the adaptor housing, this could affect the sterilization process. / La partie centrale de la compo
  inadequate packaging seal. Warning labels on the kit will instruct users not to use the affected component. / Les composantes de l‟aiguille d
neau horizontal peut atteindre jusqu‟à 4 mm.
ms with revision of the ETX boards. / On a rapporté des problèmes relatifs à la présence occasionnelle d‟artefacts, à des arrêts sporadiques
 C level of approximately 90,000/UL. / Dans 95 % des cas, une cellule ou moins peut être transférée à une préparation microscopique faite a
 ce & tube column move toward ground stopping at end stop without console joystick activation. / On a rapporté des mouvements involontaire
 ewer in wrong context. In rare cases single images are not referenced and shown within the patient examination. / Dans certaines circonstan
ch was defective it is necessary to check each site for the faulty switch holder for exchange. / Un bloc d‟interrupteurs a été changé en 2005 e
he assigned range when used with the MDA auto dimer (T3103). Lot R194025 is re-assigned to correct the problem. / Le D Dimer High Cont
 f prepared daughter tubes, including newly added specimens before incubation is finished for the last specimen. / Lorsqu'on procède manue
 d in an approximately 6-7% lower assignment for these four lots of calibrator. / Des valeurs erronées des flacons des réservoirs d'origine ont
 s ostéotomes Stella étaient plus épaisses que ce qui est indiqué dans les spécifications.
   corrects several other problems. / La fiche d‟entretien 2 (MR2) met en application plusieurs corrections relatives à la conformité des normes
0 where 'A' indicates the device has alarm functions. / Erreur d‟étiquetage. L'étiquette au dos de l'appareil peut montrer le modèle 2500A plut
  execute with the shear valve disassembled and expose the operator to liquids from the system. / Pendant un entretien de routine de la valve
  umber of Axys printers were shipped with the film calibration parameter set "off". / Le processus de production de Drystar Axys précise que
here is a possible error (up to 8mm) in the reported table longitudinal position. / On a observé un problème dans les versions 6.1, 6.2 et 7.0 d
ect parameter flag on the cell-dyn 3500 and the cell-dyn 3700. This occurs when the rate of WBC's passing through the instrument's flow cel
  2007 and March 2008 were incorrect. / Certaines valeurs inscrites sur les feuilles de paramètres des systèmes de chimie Advia vendus entr
ers may not be able to program affected pumps to receive glucose values from blood glucose meters provided. / Les pompes rappelées cont
use an intermittent short. If this occurs, it may result in no delivery of a defibrillation therapy shock. / Un nombre limité d‟appareils ont été fabr
more prone to fracture during use, which yields a metal fragment that is at risk of being left in the patient. / Un des fournisseurs n‟a pas respe
  he current manufacturing process, separated unretrieved fragments may embolize and cause vessel occulusion. / Des lots fabriqués avec u
come loose and fall from the x-ray stand. / Des mesures ont été prises sur le terrain pour corriger un problème relatif au collimateur d‟un sys
 ys refrigerated and from 3 months to 2 weeks when frozen. / La durée de vie de l‟ensemble témoin a été diminuée de 24 heures à 8 heures
e some lots of trillium-coated cardiopulmonary bypass products, including oxygenators, reservoirs, pumps & tubing packs. / Trois lots d‟hépa
rm the Digoxin II assay, however, those disks do not contain the Axsym Digoxin II assay file. / 1. La notice d‟accompagnement du logiciel aff
  pencil beam algorithm when the Monte Carlo algorithm is selected, with no indication of this occurring. / Si le bouton Suivante est utilisé pen
 gated radiotherapy treatments when phased-based gating is used. / Une anomalie a été décelée dans la version 1.7 du système RPM. Un d
 on bactérienne possible du nettoyant à miroirs par Burkholderia cepacia.
 assembled (missing, bent or broken) springs during manufacturing or servicing of the mechanism assembly. / La société Cardinal Health a r
evel of fluorescence. / Les calibrateurs des trousses ebv igg, ebv igm, syphilis igg et ana screen pouvaient produire une fluorescence réduite
s in the device are not corrected as per Bio-Rad‟s directives. / Un risque de décalage de l'identification des échantillons par codes barres peu
  ntrol for Neisseria gonorrhoea) may vary according to the lot, and especially to the methods of analysis. / La réactivité et la performance de l
  emolysis or with triglycerides and fractioned heparines. / Le rappel est du a un changement dans l'interprétation des données sur les interfér
 t. / Les résultats des tests de lipase peuvent être modifies (augmentation) lorsqu'ils sont effectues après un test ldl.
   L'écrou localise dans la partie inférieure de certain modèles de balance peut se desserrer sous certaines conditions.
   Certaines différences mineures ont été remarquées dans la version anglaise du guide de l‟utilisateur de la pompe à insuline Animas 2020.
  or changes with the detector filed of view (FOV) size OT changes SID while smartmask is active. / L‟image du masque pour le calque Smart
  the regulator "needle", when it should indicate clock-wise rotation of the regulator "knob". / Le manuel d'utilisation indique qu‟une aspiration
emote control feature. After an interrupt is generated and handled by the software it should be reset by the software interrupt handler. / L‟arc
ed is in the low position during the use of patient lifts and/or cleaning areas of the bed and areas below bed. / Il existe un risque de dommage
 ere different from that indicated on the package label. / Un examen a été effectué et on a découvert que le numéro du lot indiqué à la fois su
  vated. As a consequence, the needle cannot retract into the rear barrel. / La société BD est préoccupée par le fait que dans certains cas, il e
 fester une réactivité inférieure, voire aucune durant les tests de contrôle de la qualité.
cord the last 1 - 4 pump strokes infused into the patient when power is restored. / Durant un cycle de remplissage, si le système est éteint ou
  , which could result in skin irritation or burns or under delivery of medication. / Augmentation des plaintes relatives aux fuites lorsque le clam
s of the mask, thus they may not provide the protection necessary between the patient and the surgical staff. / Une faille survenue au cours d
h, to leach into the analytical lines and cause erroneous results. / En raison d‟un défaut de conception, les valves à trois voies peuvent ne pa
érile se trouve compromise au niveau des électrodes du crayon électrochirurgical.
  ruption ou de réduction de la circulation du liquide lorsque les canules appartenant aux lots incriminés sont utilisées.
  ntrols (used with cobas integra system). / Concentration réduite en bicarbonate résultant de la fuite des flacons de calibrateurs et des contrô
 th certain accolade TMZF femoral stems in patients classified as overweight or obese. / Risque accru de fracture de la tige fémorale lorsqu‟u
oss of patient support would be intermittent and variable. / Risque de fuite dans le système d‟entraînement à l‟hélium. La fuite déclenche une
 13090. / Il est possible que le lot ne cause pas la réaction biochimique adéquate lorsqu‟il est testé avec Neisseria meningitidis ATCC 13090.
nsertion de type Peel-Away ne se décolle pas de manière uniforme ou complètement.
 ode and quickly moved manual. This may be due to an inappropriate circuit for processing a couch-top signal. / Il est possible que le systèm
 approved device), and therefore represents a potential health hazard. / Le Transilluminator, modèle BF-150, n‟a pas reçu l‟autorisation de m
   include failure to start-up or reset of the display screen during therapy. / Un défaut dans le panneau de circuits imprimés peut causer un dys
distance of 2cm from the side of the applicator body in combination with field sizes of 5cm x 5cm or smaller. / L'applicateur variable d'électron
  ncy in the stem curvature between trials and implants. / La courbure de certaines tiges de prothèses diverge des spécifications. Ces écarts v
plantation. / Deux incidents ont été signalés durant lesquels les ballons amovibes Goldbal se sont dégonflés avant ou pendant l‟implantation.
  been no reported injuries associated with the deficiency. The only associated issue can be an intermittent function. / Dans certaines unités, l
o rise and would not stop. / Un chirurgien a signalé que le dos du siège du système laser Excimer STAR S4-IR de VISX commençait à mont
  Risk of infection and potential for erroneous results when instructions for multiple-patient use are not followed. / Depuis mai 2005, des dispo
cumentation. / Le dispositif a été expédié au Canada avant que toute la documentation concernant l‟obtention de licences n‟ait été remplie.
 ve) than the reading control band. This may lead to innaccurate interpretation of a sample as negative. / Dans un faible pourcentage de lots
ed down and re-energized after a collision has occurred of the U-arm positioner in the DR 3000 system. / Un mouvement n‟ayant pas été com
fondes entailles dans la barre au niveau du thorax.
 ient records. / Les défibrillateurs Zoll E Series avec une version 3.00 ou plus récente du logiciel peuvent transmettre ou faire imprimer les m
 ead to arrhythmia, ventricular fibrillation, acute myocardial infarction or injury to the coronary artery. / Risque de ralentissement ou d‟aucun d
 ha coated trident acetabular cups exceeded the internal validations acceptance criteria target for organic residual. / On a découvert que certa
  th certain accolade TMZF femoral stems in patients classified as overweight or obese. / Risque accru de fracture de la tige fémorale lorsqu‟u
 red between Oct 2005 and May 2007 may have utilized a component that was out of product specification. / Retrait des applicateurs endosco
e not displayed as intended). The discrepancy can be as much as a few millimetres. / La fusion des examens tomographiques comprend cer
 e. This flag is forwarded to the plate report, leading to an erroneous assay result. / Une valeur mesurée dépassant la limite de manière évide
e gated radiotherapy treatments when phased-based gating is used. / Une anomalie a été décelée dans la version 1.7 du système RPM. Un
ain conditions could cause broken records in the combined test dictionary. / L‟utilisation de toolkit.sh pour régénérer la structure du dictionnai
mode and quickly moved to manual. This may be due to an inappropriate circuit for processing a couch-top signal. / Il est possible que le syst
 esulting in inability to operate the powered table. / Dans certains cas, les boulons utilisés pour fixer le mécanisme en Z au bras (ISO-base) o
  l wells within an affected unit. Test results may be falsely elevated or depressed variably, up to 34%. / Résultats erronés avec les cartouches
 r peut se corroder et briser.
  ay. The QMS Vacomycin is equivalent to the Multigent Vacomycin. / Le test à la vancomycine peut, en de très rares occasions, donner un ré
 the sides of the plunger. The excess lubricant causes elevated hemoglobin back ground when installed. / Lors de l‟assemblage de certaines
 ssay 116 and 117) are edited after installation an error #0002 is obtained when running patient samples. / Quand les valeurs seuils positives
  igitally reconstructed radiographs (DRR's) with a shift in the superior direction. / Les versions 2.00, 2.01, 2.02, 2.03, 2.10 et 2.11 pour SGI et
 ecords from the instrument to a diskette. The upgrade provides a software correction to the issue. / Les versions 2.00, 2.01, 2.02, 2.03, 2.10
C
background
during
sample
analysis.
This
causes
increased
fluorescent
particle
flags,
resistant
and
nucleated
WBC.
/
Une
contamination
m
perte de la détection ventriculaire peut empêcher un défibrillateur cardiaque implantable (DCI) de déceler une arythmie.
 injuries. / Au moins l‟une des 4 roulettes peut se détacher en raison d‟un bris du châssis et cela pourrait causer des blessures.
 closed following stoppage of the pump. This is due to a timing delay when the pumping mechanism resets itself. / Il est possible qu‟un bolus
 mporary de-synchronization between programmer and IPG stimulation parameters. / Dans la dernière mise à niveau du logiciel, on a consta
begins between 35 and 65 mg/dl, the reported recovery drops off to ~3 - 7 mg/dl. / On a constaté que trois lots actuellement sur le marché du
 on potentielle de l‟emballage peut conduire à la perte de la stérilité du produit.
 n misidentification of non-group A streptococci. / Auto-agglutination et activité hétérospécifique. L‟utilisation continue de ces lots de Streptex
he right of the decimal comma are truncated for measurements made with the workplace measurement tool. / Si vous utilisez le signe « ) » a
 nts de la table, de l‟unité de commande et des pièces amovibles de la table.
 ation confirmed decreased potency, weakened reactivity and, in some cases, false negative results. / À la suite de plaintes concernant une d
alogue #4245, lot #2407192). Some packages from these lots may have been improperly labelled. / La cupule Allofit de dimension 50 (catalo
 utaneous ULS cannula is incorrectly identified as catalogue # 00-4828-026-16. / Dans le cas du dispositif et implant avec verrou de sûreté u
  42. / Une erreur de marquage par laser et une confusion de deux tailles de têtes Metasul (tailles 44 et 42) ont pu se produire.
 vidual leaf edits that do not match the MLC contour and 2. Can cause the collimators to change. / Le fait de modifier les propriétés de la stru
 eased risk of infection to patients. / Des taches de silicone visibles sur le matériau d‟operculage Tyvek sont susceptibles de modifier la barri
 board malfunction resulting in a premature lid opening & minor water leak within the system./ Le réservoir du chauffe-eau rouille, ce qui occa
  se peut que le sceau de l‟emballage du bistouri d‟électrochirurgie de Conmed soit erroné.
 misinterpretation of EEG locations. / Les fonctions des électrodes peuvent être incorrectes sur quelques dispositifs, ce qui peut entraîner un
 oduct lot. Component when introduced into surgical site may pose hazard of material dislodging during use. / Une bavure (semblable à un r
 Separation may occur during the process of blood transfer into infection control bag from the evacuator. / Certains lots présentent une sépar
 emolysis or with triglycerides and fractioned heparines. / Le rappel est du a un changement dans l'interprétation des données sur les interfér
of medication, contamination of fluid path, or possibility of air entering reservoir could occur. / Un nombre croissant de fuites touche certains l
 s and calibration stability of 14 days with a daily blank adjustment (architect Csystem) or blank calibration. / La phénytoïne pour épreuve bioc
ef chirp sound. Delivery of insulin is interrupted. If unnoticed, e.g. patient asleep, risk of potential harm to patient. / Si le capuchon de la pile n
overy of quality control. Quality control elevations as high as 50% seen at albumin concentrations of 10mg/ml. / L‟utilisation du calibrateur de
 ontrol plasma N and control plasma P outside the confidence range. / Le lot no 6542849 présente une grande variabilité inattendue des résu
  was identified as silicone used inside the assembly. No compromise of the sterile barrier is posed. / À la suite de l‟examen des plaintes reto
 e images show wrong orientation labels and also holds true for 3D volume images. / Les coupes résultent de données tridimensionnelles ob
 ulting in loss of vacuum. / La cupule M-Style peut se séparer de la tige du dispositif d‟aspiration pour un accouchement, ce qui entraînera un
 7 typing. The donor N2397 typing should indicate F+ (F-positive). / La liste de contrôle accompagnant le lot no ID098 de Capture-R Ready-ID
  surcharge des piles pour les produits Kion.
  nutes after the self test. / On a observé qu‟après la mise à jour du compresseur HCU 30 à 1.00.01, celui-ci se remettait en marche seuleme
 ed based on incorrect equations. The 2 parameters were Cbase (B,OX) and Cbase (ECF, OX). / On a constaté que deux paramètres dérivé
  unlicensed units imported but not distributed were 400-01-291, 400-01-292, 400-01-295, 400-01-296. / La société Encore Medical a constaté
  uent patient sample slide. / La société Beckman Coulter a établi que dans 95 % des cas, une cellule ou moins peut être transférée sur une l
  sts and Bio-Rad no longer reports the free T3 values for the affected lots. / Stabilité de la bilirubine après décongélation des flacons est plus
m the operation station display. This could result in an incorrect position for the patient during treatment. / Les nombres apparaissant dans le
  stead of 1 resulting in concordance errors. User manual does not address this error. / L‟appareil comporte une erreur de concordance. Une
  led which may lead to potential erroneous results to be displayed. / Il est possible que des oxymètres AVOXimeter 1000E ait été envoyés au
 Popper Interchangeable Hypodermic Syringe". / Le nom du produit apparaissant sur l‟étiquette indique par erreur « Seringue d‟évacuation To
 il to abort even if the high pressure pump is not working. / Dans certaines unités, pendant le cycle de stérilisation en utilisant le plateau C116
of surgical instruments in the image displayed on the Medtronic Stealthstation surgical navigation system. / Une défaillance du logiciel O-Arm
  king feature of the ACQSIM3 simulation application. The software interpretation of this info can be inconsistent. / Les tomodensitomètres de
 es from the cardiac or pulmonary viewer, and views in the ct viewer or pacs system, the measurements will be incorrect. / Lorsque l‟opérateu
  rique se produit dans le dispositif lorsqu‟on utilise trop de solution de nettoyage.
 mes dislodged during a lower extremity procedure, it is possible an injury could occur. / Il y a un risque potentiel que le mécanisme de verrou
   a HV power supply. / En vue d‟installer un couvercle portant des étiquettes de mise en garde de haute tension afin d‟augmenter la protection
cases, char and coagulum have been observed. / Le dispositif présente des caractéristiques qui entrent en contradiction avec les spécificatio
 system. However, system alerts operate properly, so users will be notified if order has not been acknowledged. / Certaines commandes et (o
monstrate the adequacy of sterilization/packaging resulted in failed USP product sterility test. / La stérilité n‟a pas été analysée avant la remise
  ion and/or expected flow rate. At low settings the flow rate is reduced with a risk of inadequate patient oxygenation. / À cause d‟un problème
g the Siemens Immulite device. / La stabilité de l'anti-TG et de l'anti-TPO est plus courte que prévue lorsque le contrôle est analysé avec l'ap
 urs plaintes ont été formulées relativement au résultat faussement positif de la trousse ELISA IgM (Captia) de dépistage du virus varicelle-zo
s of the door when closed. If door switches not properly adjusted they may falsely indicate that door is locked. / À cause de l‟absence de la go
 skin being removed when the patch was removed. / Aux États-Unis, on a signalé des cas de brûlures et d‟irritations de la peau. Au Canada,
ent. The false positive results are not observed for all test cards manufactured under this lot number. / Le produit a entraîné des réactions fa
 r. Following the Health Canada advisory notice of 2007-10-26. / Risque accru de relâchement de la prothèse causé par l‟irradiation aux rayon
wn without producing alarm or signal or it may show erratic SPO2 readings with 'small pulse' or 'lost pulse' alarm. / La polarité des condensat
  ment delivery. / On a observé un problème portant sur le déplacement involontaire du support mobile pendant l‟administration d‟un traitemen
pumps may be affected and cause an over-delivery of insulin which could result in injury to the user. / À la suite d‟une erreur de fabrication d‟
   width increasing drill during assembly of affected lot. Having no 122-237 and two 122-242 drills is redundant. / L‟article n°122 242, un foret p
  e "beam edit" function to modify a beam in an unlocked fraction group. / Deux conditions peuvent amener l‟utilisateur à modifier involontairem
n certain nombre de mises à jour du logiciel iViewGT 3.4 n‟ont pas installé l‟ensemble de services 2 (SP2), iViewGTR.3.4.
  ler clamp. Customers should not use the redesigned roller clamp with the Sigma 8000/8002 Infusion Pumps. / Les pompes à perfusion Sigm
 utton on the infrared remote control. / Le lève-personne peut continuer à se déplacer vers la gauche (ou la droite) une fois que le soignant a
C fact sheet. Problem was identified by a user.
 y was in motion and the patient was on the table. There were no injuries as a result of this incident. / Un accessoire (une cale de 60 degrés)
  ice is "ON-Q C- bloc (1-7 ml/ hr select -a- flow + 5ml / 60 min on demand)". / La société I-Flow a découvert que les deux lots nommés ci-des
   sp2. This only affects systems using the Ximatron simulator. Other simulators (eg. Acuity) are not affected. / Une défaillance du code de log
 des ON Q PainBuster PS6504 peut contenir des ON Q PainBuster, PS6502.
et extender may not provide sufficient engagement with the mating ratchet, allowing extender to slip loose. / Le prolongateur de la clé à clique
.
/
En
raison
d’une
erreur
de
fabrication,
certaines
trousses
contiennent
plus
d’un
type
de
pipette
de
transfert.
 oard.
/
La
pompe
à
galet
ne
fonctionne
pas
en
raison
d’un
défaut
de
fonctionnement
d’un
composant
électronique
sur
une
carte
de
circu
 als
with
thick
rubber
stoppers
which
have
a
concave
upper
surface
and
a
flat
bottom
surface.
/
Il
existe
un
risque
de
fuite
lorsque
le
prote
he
wrong
patient
registration
process
is
cancelled
from
the
patient
model
dialogue
window.
/
Il
existe
une
limitation
dans
les
versions
2.X,
discovered
that
the
boards
had
been
inadequately
packaged,
resulting
in
damage
during
shipping.
/
On
a
découvert
que
des
circuits
de
re
sur le certificat de dosage.
antigram
as
being
WR(A+),
is
WR(A-).
/
La
cellule
9
du
Resolve
Panel
A®,
lot
no
RA539
(date
de
péremption
:
15
août
2006),
identifiée
sur
l
 e
marché
canadien.
xpected
calculated
normalized
calcium
and
calculated
normalized
magnesium
recovery
values.
/
Un
biais
positif
d’environ
0,1
unité
de
pH
 
which
are
not
likely
to
impact
patient
results
but
which
may
impact
the
efficient
operation
of
the
analyzer.
/
À
la
suite
de
plaintes
qu’il
a

 p
level
when
used
in
certain
conditions.
/
Le
fabricant
a
déterminé
que
certaines
valves
réutilisables
Peep
10
ne
supportent
pas
le
niveau
 d
not
per
the
package
insert.
/
Le
produit
peut
identifier
erronément
un
sérogroupe
W135
comme
un
sérogroupe
Y
s’il
est
utilisé
de
façon
 ausing the capillary tubes to leak. / La dimension et la forme des bouchons situés à l‟extrémité des capillaires ne se ferment pas correctem
 oduct because once solidified, it will not dispense. In its liquid state, product is safe and effective.
/
 Le
contenu
du
flacon
peut
se
solidifier
e
 als with thick rubber stoppers which have a concave upper surface and a flat bottom surface. 
/

       Un
risque
de
fuite
a
été
observé
lorsque
le
n is asserted and then cleared with the left-hand key reset. This action can lead to an incorrect field size.
/
   Informer
les
utilisateurs
qu’une
e
 d.
/
Application
d’une
étiquette
de
mise
en
garde
liée
à
la
sécurité
pendant
l’entretien
–
Risque
d’électrocution
en
cas
de
contact
avec
le
fi
nintended motion (collision hazard). A Siemens representative will schedule a corrective update within 90 days. 
/

       Informer
les
clients
que
l’
 s since early 2005. Failure starts with partial separation of outer tube at connection to female Luer-Lock. 
/
    Augmentation
du
nombre
de
pla
 e falsely elevated results are inconsistent with the patient's clinical picture and test negative by other assays. 
/
 Des
plaintes
ont
été
reçues

s several other problems. 
/
 La
fiche
d’entretien
met
en
application
plusieurs
corrections
relatives
à
la
conformité
des
normes
CEI
et
corrige

Une
erreur
de
fabrication
explique
pourquoi
certains
ensembles
contiennent
plus
d’un
type
de
pipettes
de
transfert.
ome error conditions may cause delay in reporting positive cultures to the LIS.
/


     Quand
le
système
Observa
est
relié
à
un
système
de
gestio
 ers were providing inaccurate information to the clinician. This is due to a software defect. 
/
  .
À
la
fin
du
mois
d’août
2007,
la
société
Philips
 n and product transfer. This is being added to the product manuals. 
/
     Lettre
d’information
sur
le
produit
concernant
la
quantité
de
plasma
ropped onto a hard surface, resulting in an unreadable lot number or date/time information, or may also appear blank. 
/
        Les
lecteurs
distribu
product resulting in the omission of the required ISO symbol indicating units are sterilized with ethylene oxide. 
/
    Une
modification
du
rappel

 urgery. The movable cradle component could detach from the saddle under extreme manipulation of the associated rods. 
/
             Les
vis
incluses
ser, which results in the stiff tip instead of soft tip of guidewire extending out of the dispenser first. / Il est possible que les fils-guides condition
s at 2-8 degrees celsius. / Certains lots de calibrateurs d‟anticorps dirigés contre la péroxydase thyroïdienne ne respectent pas les spécificati
 pared to plasma samples. / Les valeurs de dose obtenues avec la trousse de réactif Access Insuline Ultra Sensible varient selon que le test
                                                                                        Des
 visual alert notification, displayed a buffer overflow code and stopped infusing. /
 arrêts de la perfusion ont été signalés dans certaines co
 l cannulae are found in two sets that were distributed in Canada / Il est possible que les canules vasculaires de certains lots ne soient pas é
mniwedge, which will not be detected by the deskto pro if high values are set within the icom tolerance table. / Il est possible que les collimate
orrect positioning of the detector in the longitudinal or lateral direction. /Un potentiomètre ou un commutateur à glissière défectueux dans le b
during instrument operation. / Défauts visuels intéressant les cuvettes de réaction, qui risquent de compromettre la capacité de lavage de l‟a
nicel dxl 800 instruments that have received noise modifications. / Les variations de température survenant après l‟étalonnage risquent d‟aug
 ected range. / Il arrive que les valeurs exprimées en pourcentage obtenues pour les basophiles (ba%) soient inférieures à la limite inférieure
as stated. / La marge d‟erreur pour le réactif myoblogine est inférieure ou égale à 10 %, mais pas inférieure à 8 %, tel qu‟indiqué.

 sage or advisory level alarm preceding a system alarm, audible alarm & flashing yellow border does not occur. / Si un patient est surveillé av
 rcode. An expanded investigation revealed additional lots and other parameters na+, k+,pco2,cl,ca,ph. / En raison d‟une erreur de transcript
doigt de l‟opérateur pourrait rester coincé entre le rouleau fixe et le dessus de la table coulissante.
    

 the device. / La puce mémoire de ces unités possède un nombre limité de cycles lecture-écriture qui réduit la durée d‟utilisation du dispositif

  rom archive or sent to a dicom destination, this angle correction is mistakenly disregarded. / Lorsqu‟un spectre Doppler à onde pulsée affich
 in combination with certain IV bags. / Rupture du perforateur de l‟adaptateur pour perfusion Phaseal C100 lorsque le dispositif est utilisé ave
mplant devices. Physicians provided with recommendations for patients implanted with devices. / Suspension volontaire de la distribution en
es, mis-synchronization may result in a variance between intended injection parameters/programmed and delivered. / Lorsque les paramètre

 sed but acceptable potassium curves that fail by quality control being out of range low. / Dans plusieurs lots de l‟étalonneur du dispositif de c
with Durom Acetabular Component size 56 (catalogue 01.00214.056, lot 237993). / Il est possible que le composant cotyloïdien Durom de tai
 dis B/E Coli K1 latex test reagent. / Il y a un petit nombre de réactions faussement positives sur des prélèvements de liquide céphalo-rachid
may be mismatched. As this may not be obvious to the user, the user may not realize the incorrect results. / La société BD a déterminé que s
layed TI (incorrect values are displayed) and operational manual MI/TI values (values shown in manual incorrect). / Le fabricant a identifié tro
anel in Aplio XG model number SSA-790A. / Faire un arrêt sur image à l‟aide de la fonction « clip start » peut entraîner un verrouillage du pa
 start. / L‟affichage à l‟écran de l‟unité de contrôle centrifuge disparaît dès qu‟on appuie sur le bouton « start », et la pompe ne s‟active pas.
pack. / Il y a des défauts de calibration et des baisses intermittentes et progressives des valeurs posologiques à l‟intérieur d‟un même ensem


 la société Biomet Microfixation ne sont pas de la bonne longueur.
 n, and error code 1054 on architect c systems when cartridge is initially placed into use. / Certaines cartouches peuvent entraîner une diminu
 is is an extension to the recall initiated in October 2006. / La barrière stérile de l‟emballage des sondes d‟aspiration Frazier et Poole a été af
orrect patient, contamination of a sample, or delay in results reporting. / La présence de cinq facteurs qui, dans certaines circonstances, pou
  ly identified the product as Unitek stainless steel primary molar crowns. Product code on package lid is correct. / Les couronnes pour molair
e seal of the product package at the corner of the outer tray and tyvek lid. / Le fabricant a émis un rappel pour ces dispositifs par mesure de
  troller, enforces use-restrictions on homing the FPP, and addresses a problem with the 1.5 maintenance release. / Cette mise à jour rectifie
  842) instead of the correct size "F" provisional (catalogue 00-5755-016-02). / Les lots de taille “F” (no de catalogue 00-5755-016-02) peuven
 ontain particulate matter from one plastic bag supplier. / Il est possible que certains accessoires emballés entre le 10 et le 12 octobre contien
distance of 2cm from the side of the applicator body in combination with field sizes of 5cm x 5cm or smaller. / L‟applicateur variable d‟électron
 evaluation of this lot was completed using negative urine. A percentage of false positives were observed. / Un certain nombre de plaintes on
ring the product by trimming the tab near the securing stitch and weakening product integrity. / Les modèles numéros 240 et 242 de supports
al images used for position correction (offset calculation) following filtering operations. / Émettre une mise en garde sur l‟innocuité aux sites p
between the electronic circuit and battery, which made lead to sudden cessation of therapy. / Un certain nombre d‟appareils pourraient être s
   rings. / Certaines unités du lot ont été emballées sans l‟information gravée sur le rebord et sans anneau de blocage.
evel when used in certain conditions. / Le fabricant a déterminé que certaines valves réutilisables Peep 10 ne supportent pas le niveau de pre
 played even though the sensor is not attached to the patient potentially causing user to miss a desaturation event. / En utilisant certains type
  ersacare bed side rails which may have the potential to lead to patient injury. /En examinant les plaintes, la société Hill-Rom a découvert que
not stay closed. This may result in the user being exposed to the sample in the cartridge. / Certains lots de cartouches i-STAT ont des bouton
 te un risque pour l‟opérateur de se pincer le doigt entre le rouleau fixe et la table coulissante.
  Multiset version 2.1 and later version. / La société BD a déterminé qu‟il existe un problème chez les clients utilisant une combinaison du sys
orts pour tubes de lyse risquent de mettre en jeu la stérilité des éprouvettes.
  to choosing a stent-graft that is longer than needed. / La longueur aortique fournie par le protocole d‟analyse d‟aorte peut être surévaluée. L
  e blade holder may fall out of the device during the process of disposal. / La société BD a déterminé que les supports pour la rétraction de la
 tabilité en temps réel a révélé une variabilité accrue des valeurs du métabolite.
 upted, causing the user interface to flicker or go dark. Alarms and ventilator function not affected. / Certains ventilateurs peuvent avoir des d
ol Universal level 2. / Baisse de stabilité après la reconstruction du constituant de thyroglobuline (TG) au niveau 2 du Precicontrol Universal.
 k, may have an inadequate seal on its sterile packaging. These were included in 2 lots of Medline trays DYNJ23314. / L‟emballage stérile du
  moved it may cause the stopper to become dislodged or loosened which renders the bottle unusable. / La société BD a déterminé que ces lo
  ceramic chip capacitor. The defect is identified as a microscopic voiding of the ceramic dielectric material. / Il existe un risque de défaillance
sence possible de "burkholderia cepacia" dans la solution antibuée, lot 000025622.
 ealth Canada. / Le numéro de lot touché a été importé au Canada, puis le produit a été distribué avant l‟approbation de la modification de la
e. / Les réactifs de AxSYM Gentamicin montrent, à la longue, une diminution de l‟amplitude entre les valeurs des calibrateurs A à F.
 r Asteion systems. / Le générateur haute fréquence installé dans le support mobile est susceptible de présenter une défaillance en raison d‟u
ot able to guarantee the sterility of the product. / La stérilisation de ces produits n‟est pas conforme à la norme ISO 11135. La société Colopl
  set of pacemaker or inhibition of pacing if the patient's intrinsic rate falls below the programmed lower rate. / Si les dispositifs sont programm
 r while in a raised position. When returned to lowest position genitals may be pinched between seat and frame. / Les organes génitaux de ce
  configuration at the patient link console, the caregroup overview bar on each bedside monitor may fail. / Lorsqu‟un moniteur patient exécute
  e pumping channel causing hairline cracks which can go unnoticed during preventive maintenance inspection. / Dans certains cas, la surven
 ar technique was previously determined to have caused a loss of vacuum on the inner foil pouch. / Il est possible qu‟une technique de scelle
  ge may occur during the installation of the tubes or after a short time in use. / Les sondes d‟intubation de couleur blanc-jaunâtre peuvent se
  ossibility exists that damage to the packaging may have compromised the sterility. / Le lot du dissecteur courbé Endopath de 5 mm avec cau
 ufacturer. / Des modifications ont été apportées à certains guides d‟alignement de la prothèse Genesis II sans l‟approbation du fabricant.
ay respond to the alarm state by stopping. In some cases, user was unable to reset the system. / Les détecteurs se sont mis en état d‟alerte
 of test and test result for a specific specimen(s). / Des index corrompus figurant dans la base de données permettant la gestion des prélèvem
nternal mounting screw making contact with electronic circuitry within the pump. / Lorsque le bouton de mise en marche a été enfoncé, rien n
pump housing when placed paracorporeally, a leak can develop at the attachment point of the line to the pump. / Si la ligne percutanée est so
e results may not be appropriately flagged for the Hemoglobin (HBG), MCH and MCHC parameters. / Lorsqu‟on effectue la conversion des u
 ry date for products with an expiration date between June 2008 and August 2011 inclusively. / La partie du sachet stérile qui est constituée d
mismatches of labelling in some circumstances. / Dans certaines circonstances, l‟intégration de deux systèmes logiciels a créé une possibilit
 s potential for arching and damage to surrounding tissue. / Le produit ne comporte pas d‟isolation. Si l‟instrument entre en contact avec un d
 riations in the x-ray intensity, resulting in changes to the contrast density of images. / Le numéro de tomodensitomètre peut se modifier en ra
  ogiciel ne se rafraîchit pas dans certaines circonstances, ce qui peut produire des résultats erronés.
rs. / Défaut des spécifications du produit pour la faible absorbance, ce qui entraîne des erreurs d‟étalonnage pour les analyseurs automatiqu
 ocessed may exhibit the presence of cellular subcomponents of the control material. / Une préparation microscopique produite par le slidem
  peuvent se produire si les paramètres cytologiques sont importés durant l‟acquisition.
-dependent false prolongation of Prothrombin Time (PT) and elevation of International Normalized Ratio (INR) / Introduction d‟une nouvelle
  ter(s) falling out of the base of the VP8500 video cart. / Il est possible que les roulettes de guidage se desserrent, et les roulettes peuvent do
n unit. / Lot de moteurs défectueux. La défectuosité se constate par la perte de graisse au niveau du réducteur de vitesse.
of six peel pouches leading to question the integrity of products. / Un défaut a été découvert dans l‟appareil d‟emballage, ce qui peut produire
ng suite. This applies to an identified batch of vent-pipes from a specific supplier. / Il existe un risque possible d‟échappement d‟hélium à l‟éta
de "burkholderia cepacia" dans la solution antibuée.
 level when used in certain conditions. / Le fabricant a déterminé que certaines valves réutilisables Peep 10 ne supportent pas le niveau d
de "burkholderia cepacia" dans la solution antibuée.
peut être compromise en raison d‟un défaut de l‟emballage hermétique.
 instrument was designed, a software upgrade will be completed. / En cas de défaut d‟un détecteur, seule une alarme visuelle s‟affichera sur
porting weld failures in the 374 mattresses shipped with discontinued material. / Il existe une possibilité de défaut de soudure dans la housse
 onsistently in same location, both during run as well as post-collection. May result in product contamination. / Une fuite peut se produire près
 the production database to the relational database. / Un écart peut se produire entre les données démographiques de 2 patients lorsque les
equent hydrogen peroxide contact following a completed cycle and incorrect compatibility lists. / Des résidus de couleur pâle ont parfois été
de stabilité en temps réel a révélé une variabilité accrue des valeurs du métabolite.
peut obstruer la valve de gonflement, ce qui empêche le ballonnet de se dégonfler.
m
operating
until
the
condition
is
cleared
by
power
cycling
the
device.
/
La
grande
pompe
à
galets
peut
présenter
un
problème
de
vitesse
m
or
overpressure
alert/alarm
condition.
/
La
pompe
peut
s’arrêter
sans
émettre
de
signal
sonore
à
cause
de
l’effacement
rapide
du
signa
even
if
the
battery
is
fully
functional.
/

Même
si
la
pile
est
entièrement
fonctionnelle,
le
message
de
service
suivant
peut
s’afficher
«
La
pi
a
service
message
and
become
non-operational.
/
.
Il
pourrait
y
avoir
une
perte
de
communication
entre
la
pompe
et
le
moniteur
de
cont
 
off.
/
Le
système
de
détection
des
bulles
d’air
peut
continuer
à
faire
sonner
l’alarme
de
détection
de
l’air
par
erreur
après
que
celle-ci
ait
  Femoral Stem that is also distributed in Canada. / Le Versys Advocate Femoral Stem a été emballé avec le centreur qui accompagne le CP
 g
in
severe
hypoglcemia.

Users
muse
avoid
exposing
the
pump
to
stong
magnetic
fields
such
as
MRI
as
stated
in
the
labelling.
/
Si
la
pomp
 h
could
lead
to
increased
difficulty
to
load
the
chambers
into
the
machine.
/
Les
portoirs
de
la
chambre
de
centrifugation
ne
sont
pas
con
 
operation
as
expected
when
the
alarm
condition
is
quickly
cleared.
/
La
pompe
à
galets
s’arrête
à
la
suite
du
déclenchement
de
l’alarme


 Cell
Enumeration
Kit
(340498).

Some
bottles
failed
to
meet
internal
stability
specifications
and
poor
resolution.
/
La
société
BD
US
a
obse

and
reduce
the
likelihood
of
occurrence.
/
Révision
du
logiciel
actuel
pour
corriger
le
problème
lié
au
retrait
excessif
de
liquide
durant
le
tr
w
heparin
syringe
carrier.

If
the
new
process
is
not
followed
a
risk
of
negative
pressure
exist
with
the
potential
for
overdelivery.
/
Dans
le
c
e
séparer
et
se
détacher
de
l’unité
pendant
l’utilisation.
samples
and
lower
than
expected
results
at
the
upper
limit
of
detection.
/
L’attribution
d’une
valeur
erronée
au
calibrateur
F
(lot
08096)
p
e for the image orientation labels to be incorrect. / Lorsque deux applications du produit (réflexion et capture secondaire) sont utilisées si
 ion
in
a
flexible
hybrid
circuit.
/
L’analyse
des
données
provenant
de
tests
du
fabricant
montre
que
ce
dispositif
peut
présenter
une
fissure
orisation de mise en marché.
 ing could impair the tracing of the bottles by the instrument. / Une augmentation de la frequence des messages d'erreur "Error code 19"
  
the
detector
was
disabled
and
the
collimator
went
into
manual
mode.
/
Le
collimateur
Ralco
302
ACS
installé
sur
l’appareil
DR3000
n’aff
 ult
in
the
tip
being
propelled
from
the
probe.
/
.
Relâchement
possible
du
joint
brasé
de
l’embout
fixé
au
corps
de
la
sonde,
par
conséque
  / Stabilite du phospore, HDL, LDL et des triglycerides n'est plus conforme aux valeurs publiees.
y
2,
2007,
however,
the
shortest
dated
component
has
an
expiration
date
of
January
31,
2007.
/
L’étiquette
de
l’ensemble
est
erronée.
La
  et
on
a
consistent
basis.
/
Une
analyse
effectuée
par
l’entreprise
confirme
que
l’allégation
relative
à
la
stabilité
prévue
du
produit
Access

 se
of
the
live
gate
region
may
generate
erroneous
but
credible
results
if
region
modified
during
acquisition.
/
La
documentation
de
l’utilis
h
may
allow
the
heating
fluid
to
enter
the
patient
fluid
path
or
vice
versa,
which
can
cause
contamination
of
the
blood.
/
Certains
échange
  nt
injury.
Also,
surgical
planning
may
be
displayed
inaccurately
during
navigation
and
misinterpreted.
/
Une
trajectoire
erronée
peut
être

 d
to
mis-diagnosis.
/
De
l’huile
peut
se
répandre
dans
la
fenêtre
gauche
(hublot)
du
tube
du
tomodensitomètre
et
causer
la
formation
d’ar
 occur and healthy tissues may be irradiated instead of the tumor. / Si le mécanisme manuel de libération du lit est utilisé au lieu des boutons
 
macro
applications
unless
the
user
touches
the
screen
or
clicks
a
function
after
re-synchronizing
the
clocks.
/
Le
logiciel
BacT/View
utilisé
 ed
in
sodium
citrate
or
Edta
plasma
collection
tubes.
/
Des
plaintes
reçues
font
état
d’une
augmentation
de
la
réactivité
et
de
résultats
fa
 omaly
occurs
during
the
pump's
startup
sequence
when
the
pump's
preventative
maintenance
alarm
goes
off
preventing
it
from
complet
rrectly
labelled
on
multi-planar
reformation
images.
/
Une
anomalie
a
été
découverte
dans
Isite
Pacs.
Celle-ci
peut
étiqueter
de
manière
e
es
of
conjugate
or
two
bottles
of
assay
diluent
instead
of
one
bottle
of
each.
/
Un
petit
nombre
d’ensembles
de
réactifs
ont
été
incorrecte
duct cannot be cleaned adequately following use. / Le produit est étiqueté comme étant réutilisable, mais il est possible que le manche tu
 tored on the system to become corrupted, which could result in lost x-ray images. / Pendant que le système sauvegarde des données sur l
s
may
be
squeezed
if
a
person
was
to
place
them
in
this
region
while
the
gantry
was
tilting
from
an
angle
to
zero.
/
Le
système
a
un
espace
 n that the +0 dimension and the -3 dimension had been switched. / Un tableau des dimensions figurant sur le dessin et le plan du produit
of
probe
tip
breakages.
While
unlikely,
the
same
issue
could
occur
in
the
25
gauge
high-speed
cutters.
/
Le
fabricant
a
récemment
retiré
d
  stratification of 0.1 ng/ml with results as high as 11.8 ng/ml. All tests run will exhibit false elevations. / Les lots touchés peuvent présente
 O2
(fraction
of
inspired
oxygen).

In
RADIANCE
V2.60,
there
are
two
situations
in
which
changes
to
FIO2
value
are
not
reflected
in
memory
 
the
collimator
flange
could
potentially
become
loose.
/
Les
boulons
de
montage
qui
fixent
l’assemblage
sur
lequel
le
tube
à
rayons
X
est
m
e
and
cable
connections
to
prevent
system
instabilities.
/
Des
améliorations
au
système
et
au
positionnement
à
l’aide
des
ultrasons
sont
n
 se negatives and incorrectly influence clinical decisions. / Un lot présente une diminution de la sensibilité, qui pourrait avoir un effet sur le
 loaded
into
Medicad
or
Voxar,
the
resulting
may
be
attached
to
the
wrong
patient
when
being
imported
back
to
Impax.
/
Lorsque
des
rés
e
ventilator
will
not
resume
normal
operation.
Visual
alarm
not
displayed,
although
safety
valve
remains
open.
/
La
valve
de
sécurité
peut

 the
high
speed
handpiece.
/
Le
capuchon
peut
se
démonter
après
un
abaissement
répété
lorsqu’il
est
installé
dans
la
pièce
à
main
à
haute
 permis
de
prévenir
les
mouvements
fortuits
du
support
mobile.
 
problème
de
stabilité
du
produit
affecte
la
durée
de
conservation
et
l’étalonnage
du
réactif
benzodiazépine.


 ant
and
explant
procedures,
to
modify
the
explant
procedure,
and
to
recommend
an
explant
only
if
necessary.
/
L’alerte
de
sécurité
a
pou
n
batches
of
the
matrix2
detachable
coils
were
missing
temperature
indicators
on
the
inner
pouch
label.
/
Au
cours
d’inspections
d’entrée

 an,
Bioban
plus
and
NS
ISE
reagents.
/
Les
résultats
d’études
sur
les
anticoagulants
ont
montré
que
les
tubes
K2EDTA
sont
incompatibles
a
 system
fails
to
boot.
/
Risque
de
verrouillage
du
système,
affichage
incorrect
de
l’image,
de
calcul
erroné
de
la
dose
et
de
la
région
du
pro
 system
fails
to
boot.
/
Risque
de
verrouillage
du
système,
affichage
incorrect
de
l’image,
de
calcul
erroné
de
la
dose
et
de
la
région
du
pro
 system
fails
to
boot.
/
Risque
de
verrouillage
du
système,
affichage
incorrect
de
l’image,
de
calcul
erroné
de
la
dose
et
de
la
région
du
pro
xceeding
the
assay
file
validity
criteria
and/or
elevated
negative
control
values.
/
Risque
d’erreurs
d’étalonnage
pour
un
lot
spécifique
cau
 r
in
the
closed
position.
/
Risque
de
bris
ou
de
flexion
de
la
pince
du
système
d’ouverture
de
la
porte
conçue
pour
garder
la
porte
du
détec
at
was
detected
by
an
automatic
self-test.
If
this
occurs
the
operator
may
be
unaware
and
the
device
may
not
shock.
/
Rappel
des
apparei
 l
lots
of
Architect
Stat
Troponin-I
reagents.
/
La
déclaration
sur
l’étiquette
relative
à
la
sensibilité
analytique
inférieure
ou
égale
à
0,01
ng/
 cess
deployment
force.
Devices
manufactured
during
October
2006
time
frame
may
have
higher
deployment
force.
/
Nous
avons
récemm
al
risks
associated
with
the
use
of
the
product.
The
ifu
changes
are
designed
to
reduce
the
incidence
of
"carving".
/
Certaines
modification
 he
air
detector
will
become
disabled
.
This
could
allow
the
air
to
be
delivered
to
the
patient.
/
Si
le
réchauffeur
de
liquide
est
éteint
penda
ms to correct problems associated with the calibration and reading of weight scales, flow discrepancies and frozen screens. / Le fabricant
 the blood pump, the air bubble detector and the syringe pump. / Le fabricant a émis l'avis 16B pour annoncer le remplacement des peson
 c
syringe
only
contains
100
units.
/
Les
étiquettes
extérieures
des
ensembles
ABG
sont
erronées
et
indiquent
qu’ils
contiennent
200
unité
versa.
This
error
makes
the
product
unusable.
/
Une
électrode
de
défibrillateur
avec
un
connecteur
Medtronic
peut
éventuellement
conte
La
stérilité
d’un
nombre
limité
d’unités
est
compromise
en
raison
d’un
trou
minuscule
dans
la
pochette
stérile.

 scan
paused
without
request,
inappropriate
attenuation
correction,
decreased
activity
(cold
spot).
/
Le
patient
peut
être
coincé
entre
l’ap
 600k. When the red blood cell result is edited, the HRL number is calculated incorrect. / L‟appareil peut fournir une numération des globule
 fiber,
detachment
of
metal
cap,
and
fiber
lasing
straight)
during
use
for
devices
manufactured
after
Feb.1/06.
/
1)
Absence
des
marques
d
rocedures
which
will
reduce
risk
of
death
and/or
serious
injury
due
to
an
opioid
or
sedative
drug
overdose.
/
Séance
de
formation
pour
ra
dhesive
which
can
cause
the
nose
to
separate
from
the
body
of
the
device.
/
L’embout
conique
fixé
à
la
partie
principale
de
certains
lots
d
th
LSI
ATM
SG/P53
SO
probe.
/
Contamination
dans
un
sous-ensemble
de
flacons
équipés
de
sondes
VYSIS
LSI
ATM/P53
et

D13S319/CEP

"central
islands"
in
patients
following
myopia
procedures.
Some
patients
exhibited
a
decrease
in
visual
acuity.
/
Ce
rappel
fait
suite
à
plusie
dle and t-handle which make fit slightly difficult. / Le manche d‟insertion de la vis tire-fond ne s‟insère pas bien dans le manche en forme de
                                                                                                                                 

  cision
diminuée
dans
les
valeurs
inférieures
de
l’intervalle
de
concentration,
inférieures
à
la
zone
de
décision
thérapeutique.

  to detect an accurate pressure reading. / Le raccord Luer du coude du tuyau expiratoire peut se boucher, ce qui nuit à la capacité des ven
dle
(in
the
holder)
to
become
separated
from
the
hub
and
remain
in
the
stopper
of
thee
vacuated
blood
collection
tube.
/
La
société
BD
es
o
the
canfusepace
study
and
turn
off
and
remove
the
software
from
the
implanted
devices
of
patients
already
enrolled.
/
En
raison
d’une

occupée
par
le
fait
que
l’emballage
d’aluminium
n’est
pas
bien
scellé.
 locking
pin
may
not
function
properly.
/
Les
tiges
de
blocage
du
guide-foret
perméable
aux
rayons
X
n’ont
probablement
pas
été
assembl
w rate discrepancies without interrupting patient treatment. / Le fabricant a émis l‟avis 19 pour fournir des instructions et des procédures de c
rial clamp may not be strong enough to ensure the occlusion of the line./ Les tubulures du lot 07m15751 pourraient avoir été assemblées
 ement
expédié
un
produit
qui
n’avait
pas
reçu
l’approbation
de
l’Association
canadienne
de
normalisation
(CSA).
e
speaker
tone
at
power
on
may
ring
out
of
sequence.
/
Un
petit
nombre
de
pompes
à
perfusion
peuvent
s’arrêter
par
une
simple
pressio
/ Les systèmes Aplio munis de la version 6 du logiciel affichent des résultats erronés en mode de mesure du débit cardiaque.

sur le marché une mise à jour du logiciel - la version 2.0.9.
 s
que
l’utilisation
du
mode
maintenance
est
réservée
uniquement
au
personnel
autorisé.

ouveaux rails de fixation sont désormais nécessaires pour empêcher le retrait involontaire des tablettes amovibles.
e
order
S-W-T-P
instead
of
the
correct
order
W-S-T-P.
/
Certaines
trousses
d’un
lot
comportaient
une
erreur
de
configuration.
En
effet,
dan
 G. / Trois lots de STA-Liatest VWF:Ag présentent un effet crochet pour des taux de VWF:Ag supérieurs à 300 %.
nd
may
reduce
the
time
between
elective
replacement
indicator
and
end
of
life
to
less
than
three
months.
/
Des
condensateurs
à
basse
te
 re
missing
the
temperature
indicators
on
the
inner
pouch
label.
/
Au
cours
d’inspections
d’entrée,
on
a
décelé
que
certains
lots
de
spirale
al
button
presses
or
additional
force
to
actuate
the
button.
/
Un
bouton
situé
à
l’avant
du
défibrillateur
peut
ne
pas
réagir
à
une
première
p
  have migrated to the staple driver. / Dans certaines unités, il est possible que la colle utilisée pour coller la coque extérieure du dispositif
w
to
the
patient
can
occur.

If
the
set
is
incorrectly
attached,
the
flow
stop
spring
lever
arm
can
be
opened.
/
Lorsque
le
nécessaire
à
perfu
s
identified
microbial
contamination
in
some
vials.
/
Un
lot
de
cellules
servant
à
la
vérification
(cellules
regroupées)
présente
une
importan
ment
to
discolor
when
cleaned
or
sterilized.
/
La
rugine
Molt
no
9
peut
ne
pas
avoir
été
polie
complètement,
ce
qui
est
susceptible
d’entra
zer
Systems
when
a
sample
with
a
high
HGB
is
run.
/
L’analyseur
d’hématologie
AC
TTM
5diff
peut
générer
des
résultats
erronés
en
donna
 nserts
supplied
with
the
kits.
/

Les
valeurs
totales
des
protéines
ont
été
attribuées
incorrectement
et
ont
été
publiées
comme
telles
dans
a potential biohazard. / Le bouchon du tube témoin est enfoncé dans le flacon lorsque le tube est percé, occasionnant un biorisque possib
 y to detect an accurate pressure reading. / Le port Luer du coude de la canule expiratoire peut être occlus, ce qui interfère avec la capacit
s
computed
within
virtual
fluoroscopy
package
can
be
incorrect.
/
Lorsque
les
données
de
ces
systèmes
contiennent
des
décalages
de
reco
 u du niveau 1 indiqué sur la feuille de dosage est de 4,3, mais il devrait être de 3,5.
 ose,
resulting
in
the
hanger
bar
disconnecting
from
the
lift.
/
Le
fabricant
du
produit
a
reçu
des
rapports
indiquant
que
le
boulon
rattachan
ring
transport
testing
of
a
new
kit,
packaging
integrity
failures
were
identified.
/
Un
problème
possible
avec
l’emballage
a
été
relevé
à
prop
e
instrument
read
the
first
plate
instead
of
the
second
plate
and
results
erroneously
assigned
to
the
second
plate.
/
Après
une
pression
rép
 t électrique entre un câble et un raccord soit intermittent.
                                                                                                       1)
Le
logiciel
de
traitement
d’image
qu
 tor's
finger
was
pinched
between
the
fixed
roller
and
the
gliding
tabletop
of
a
proteus
xr/a
table.
/


ate in excess of 20r/min. / La fréquence du pouls par défaut peut être fixée à 25/30 impulsions par seconde (imp/s), ce qui peut occasionn
g
position
during
image
tracking,
which
could
lead
to
possible
patient
injury.
/
Le
système
peut
comporter
des
imprécisions
de
repérage
co
ew metallic smart box controller of the innova system that may impact patient or staff safety. / Une activation accidentelle du déclencheu
 eel
tip
has
disconnected
from
the
housing
because
one
of
the
pins
have
become
detached.
/
Le
boîtier
de
la
goupille
des
émetteurs
de
na
mal force is used, which could result in the screw having to be removed from the bone by other means. / La soudure entre le montant et la vis
 polie au laser puis emballée comme si elle mesurait 32 mm, au lieu de 28 mm.
s alarmes sonores et de réinitialisation de la station centrale CIC.
 ag
on
the
product
and
the
device
description
on
the
box,
product
and
internal
packaging.
/
Des
erreurs
d’étiquetage
figurent
sur
des
emb
or
needle
and
the
sampling
pouch.
/
Le
fabricant
a
reçu
des
plaintes
signalant
diverses
quantités
d’un
produit
anticoagulant
entre
l’aiguille
essed
due
to
ingress
of
liquid
to
the
handle
from
the
distal
end
causing
localized
burns.
/
L’activation
du
dispositif
peut
se
poursuivre
aprè
 gel
did
not
meet
the
specifications
in
that
the
pH
level
was
11
instead
of
7.
/
Après
l’utilisation,
le
patient
éprouve
une
sensation
de
brûlu
udden
cannula
disconnect.
/
L’utilisation
de
la
mauvaise
pince
de
serrage
(noire)
ou
du
mauvais
écrou
pendant
les
canulations
auriculaire

                              

 affiché le 2007 février 19. 
The
BD
Beaver
Mini-blade
components
within
the
above
packs
may
have
incomplete
package
seals,
potentia
maller carabiner. / Risque de débranchement des lève-patients portables des poignées de fixation s'ils sont utilisés avec les plus petits mou
ng the reagents stored at the recommended storage condition of 2-8 celsius and on-board the axsym instrument. / Une augmentation des éc
on
the
online
tdm
valproic
acid
and
vancomycin
assays
on
the
cobas
c
501
analyser.
/
Les
réactifs
R2
des
immunoanalyses
de
ch:
acn
057
e
 rapports indiquent que des temps de coagulation plus longs que prévus ont été observés.
 lances
intermittentes
des
résultats
du
moteur
de
l’agitateur
peuvent
entraîner
des
résultats
incorrects
des
dosages
de
glucose.

hics
indicate
that
the
additive
is
sodium
fluoride/potassium
oxalate.
The
actual
is
sodium
fluoride/na2edta.
/
L’étiquette
figurant
sur
le
sac

 de montage peut se briser et faire en sorte que les écrans peuvent se desserrer ou se détacher du système.
 etect an accurate pressure reading. / Le raccord Luer du coude du tuyau expiratoire peut se boucher, ce qui nuit à la capacité des ventilat

 oissance
de
l’organisme
de
contrôle
de
qualité
(atcc
12386,
Streptococcus
agalactiae).
 0se
were
not
those
for
an
elevated
control
material.
Investigation
at
Randox
Labs
Ltd.
confirmed
it
to
be
incorrect.
/
Un
rapport
provenan
 the
unit
incorrectly.
/
La
batterie
du
Ceegraph
Netlink
Traveler
peut
s’endommager
ou
surchauffer
si
elle
n’est
pas
correctement
insérée

were
left
off
the
product.
/
Échec
d’une
opération
dans
la
chaîne
de
production:

les
taquets
utilisés
pour
mesurer
la
profondeur
n’ont
pas
 ng
of
the
PETG
tray
at
the
radius.
/
Possibilité
de
rupture
de
la
barrière
stérile.
Ce
problème
serait
issu
d’une
fissure
du
plateau
en
PETG
e
on
line
and/or
container.
/
Perfusions
secondaires
d’appoint
contournant
une
soupape
antisiphon
vers
le
tube
ou
vers
le
récipient
de
perf
 incorrectly reported as less than the upper reference limit of 0.08 ng/ml (ug/l). / Les échantillons des patients présentant de très faibles conc
material
failures
before
the
labelled
five-year
shelf-life
expiration.
/
Certains
numéros
du
catalogue
et
certains
lots
d’appareils
vendus
com
ococcus
isolates
in
quality
control
testing
and
patient
sample
testing.
/
La
gélose
pour
infusion
cœur-cervelle
et
la
vancomycine
(milieu
de
atocrit
range
for
test
strips.
The
correct
hematocrit
range
is
30
to
55
percent.
/
Le
manuel
de
l’utilisateur
envoyé
entre
avril
2004
et
octob
h certain keystroke this state can be followed by inaccurate measurements. / Une erreur a été décelée dans le système de diagnostic par
5

2006
show
low
incidence
of
failure
through
fatigue
of
the
AC
connector
with
a
potential
for
thermal
damage.
/
Les
générateurs
de
press
 , particularly when it nears its expiration, due to deterioration of the enzymatic content since lot release. / Il pourrait y avoir un problème en ra
ge
of
the
assigned
values
and
results
were
underestimated
by
approximately
12%
(relative
error)
for
patient
samples.
/
Pour
certains
lots,
he
currently
claimed
functional
sensitivity
of
2nmol/l
as
given
in
the
package
insert
not
supported.
/
Réévaluation
de
la
sensibilité
fonctio
er
the
system
during
a
cryogen
transfer,
overpressure
can
develop
and
vent
helium
into
the
MRI
suite.
/
Si
l’ouverture
de
la
ventilation
à
l
 tions
with
the
total
B-HCG
specimen
diluent
can
also
result
in
an
elevation
in
B-HCG
values.
/
Certains
lots
de
test
de
bêta-HCG
total
Axsy
d for more than 6 weeks for all current lots and for 3 weeks for lot # 177331-01. / Il s‟avère que le facteur d‟étalonnage peut devenir limite lors

assay
at
value
higher
than
0.0932
mmol/l
or
0.15
g/dl.
/
Après
une
vérification
interne,
le
fabricant
a
remarqué
que
l’hémoglobine
peut
in
 tected:
separation
of
the
flipper
bar
from
the
caps,
caps
that
do
not
remain
open,
broken
cap
hinges.
/
Impossibilité
d’ouvrir
certains
ens
 025 peuvent produire des resultats faussement positifs.
he
blue
connector
and
the
stretch
safe-t
valve
and
could
result
in
the
under-delivery
of
enteral
product.
/
Un
petit
nombre
de
pompes
pou
ece
and
ratchet
adapters
and
revised
instructions
for
use
provided
to
all
customers.
/

Des
implants
dentaires
ont
été
distribués
sans
les
bo
and could lead to premature wear. / La matière dans laquelle a été faite la clé hexagonale n‟a pas été suffisamment durcie pendant la fabrica
 e
ABL80
analyzer.
This
occurs
when
excessive
pressure
builds
within
the
waste
line
due
to
a
blockage
in
the
line.
/
Des
rapports
ont
signal
 ventually
fail.
Warning
about
improper
method
of
fitting
brackets
for
lifting
units
with
hoist.
/
Les
rondelles
de
l’élévateur
d’assise
peuven
  protège-gonades du Velocity U était brisée.
applies
compensation
to
the
file
and
all
subsequently
exported
files,
even
if
the
original
file
did
not
have
compensation
applied.
This
probl
du logiciel est disponible pour le Heater Cooler Unit 30 system.
escribed
in
the
letter
is
to
update
the
c.cam
system
chair
per
the
update
instruction
mi007/07/s.
/
Une
mise
en
garde
importante
a
été
dif
mples
and

  2)patient
sample
results
are
not
consistently
comparable
to
results
generated
on
the
Axsym
Digoxin
II
Assay
/
Des
clients
ont
o
problème possible avec la composante Sanblocraid de 2 Go utilisée dans les systèmes Magicstore.
 (Standard International) as mg/dL instead of the correct mg/L. / Pour le Architect C8000, l‟emballage du réactif 30-3143/r5 est erroné, les ré
 g a reboot of the system. / Les systèmes de radiologie Allura XPER 10/10 version 1 et RD 10 version 2 peuvent se bloquer et nécessiter un
pple
assembly
may
not
be
fully
locked
in
place.
Internal
check
valve
may
collapse.
/
Il
est
possible
que
l’anneau
de
retenue
qui
retient
les

duction
in
the
number
of
mast
to
base
welds
(From
4
welds
to
2
welds).
Could
result
in
separation
and
potentially
base
failure.
/
La
base
m
peut donner une fausse indication de sensibilité de certains microorganismes au métronidazole.
u’on
appuie
plus
de
3
secondes
sur
le
bouton
marche/arrêt,
le
ventilateur
ne
se
met
pas
en
marche.
ituations, les volumes préparés par le dispositif sont plus faibles que prévu.
oming out of the casing. The harness may short circuit, spark and exhibit a flame. / L‟écran peut tourner sur son support, ce qui peut faire so
he total population. / Le fluorosphère peut présenter un défaut sporadique de rétablissement des valeurs absolues et une population fluores
t update the sample ID1 field in the external worklist file. / Le logiciel peut créer un protocole qui n‟affiche pas les bonnes données dans cert
 catheter. In some cases, the therapeutic product was shipped with the diagnostic instruction for use. / On a découvert que ce cathéter parti
es
figurent
dans
le
mode
d’emploi.
enting
a
potential
hazard
to
the
operator.
/
Les
couvercles
à
charnière
de
l’Accelerator
APS
peuvent
tomber
s’ils
ne
s’ouvrent
pas
complèt
 la société Biomet Microfixation ne sont pas de la bonne longueur.
oose
caps
could
lead
to
potential
leakage
of
bottle
contents.
/
On
a
découvert
que
des
flacons
d’un
lot
particulier
de
réactif
d’activation
s
ormed
using
lot
18943.
/
Immucor
a
reçu
des
rapports
faisant
état
d’une
réactivité
plus
faible
ou
négative
avec
des
cellules
delta
faibles
lo
and could lead to premature wear. / La matière dans laquelle a été faite la clé hexagonale n‟a pas été suffisamment durcie pendant la fabrica
aximum
shift
in
patient
sample
results
of
33%
has
been
observed.
/
Une
variation
des
résultats
des
analyses
des
patients
peut
être
observ
stem
damage.
/
Lorsqu’elle
est
pleinement
étendue,
la
table
sur
laquelle
repose
le
patient
peut
entrer
en
contact
avec
le
collimateur
stén
nnage du réactif gentamincine échoue sur la plupart des systèmes Synchron LX et Unicel DVC.

 s signalant des cas de déconnexions et de fuites.
ramic capacitors was identified. / Risque de déchargement prématuré de la batterie des dispositifs fabriqués avec certains condensateurs cé
 e
MLC
‘s
define
a
straight
edge
in
a
port
and
the
collimator
is
set
to
coincide
with
this
straight
edge.
/
Le
système
XiO
sous-estime
la
dose
ntrol,
which
may
collide
with
a
person
who
does
not
move
out
of
its
path,
causing
serious
physical
injury.
/
La
courroie
d’entraînement
du
 er
edits
field,
couch,
collimeter
&
gantry
rotation
update
with
potential
dose
misadminiatration.
/
Si
les
systèmes
de
planification
n’expor
 is not being used. / Correction du risque potentiel de trébuchement sur le cordon à l‟usage du patient si le dispositif d‟attache du cordon n‟e
   customer. / Réactions positives faibles aux tests de Coombs directs, ce qui oblige le client à subir des analyses supplémentaires pour dét
 limator
and
gantry
rotation
at
maximum
speeds.
/
Lorsqu’on
appuie
sur
la
barre
actionnant
le
mouvement,
la
machine
peut
faire
bouger

half
cycle,
Dentsply
Friadent
Ceramed
has
changed
the
product's
indications
for
use
from
reusable
to
single
use.
/
Comme
aucune
validati
ar
code
identified
on
the
cal
solution
2
product
is
actually
the
bar
code
for
the
rinse
solution.
/
L’étiquette
de
la
solution
d’étalonnage
des

n
combination
with
the
Elecsys
Folate
II
reagent.
Accumulation
of
the
gel
will
lead
to
signal
loss
and
false
results.
/
Un
dépôt
semblable
à
u
 
an
additional
artifact
band
above
the
HBA
fraction
on
all
the
samples.
/
Le
fabricant
a
identifié
un
défaut
concernant
les
gels
contenus
da
onitor
will
continue
to
display
visual
alerts.
/
Le
haut-parleur
diffusant
les
alertes
sonores
peut
tomber
en
panne
et
ne
pas
signaler
d’alarm
ns,
10
mg/dl
and
30
mg/dl,
listed
on
the
cap
labels
are
correct.
/
Le
système
d’étalonnage
universel
pour
la
microalbumine
a
interverti
les

 e
to
flow
into
the
bag.
/
Il
peut
y
avoir
un
défaut
de
la
feuille
d’aluminium
utilisée
pour
la
fabrication
de
la
poche
d’urine.
La
feuille
peut
se
oxide,
which
can
result
in
bond
failure.
/
Le
produit
présente
une
concentration
de
l’initiateur
chimique,
le
peroxyde
de
benzoyle,
moins
él
g,
the
label
on
the
channel
does
not
control
the
functionality
of
the
channel,
potenial
for
incorrect
medication.
/
Le
fabricant
a
découvert

tly
serviced
(by
technical
engineer).
/
L’automate
de
coloration
de
lames
Benchmark
peut
faire
un
court-circuit,
ce
qui
peut
brûler
ou
brise
 There is a small potential for inadvertent laser activation and eye damage without a shroud. / Le fabricant a déterminé qu‟il manquait un écra
ver
tightening
of
the
optical
coupler.

There
is
a
potential
for
diminished
light
transmission
from
handpiece.
/
La
pièce
à
main
fournie
avec
 la barre de support Pectus de 14 po de Lorenz peut ne pas être exactement centrée.
 té Becton Dickinson craint que certains de ces produits puissent donner un faux résultat négatif.
&
operator
overrides
sensor's
alert
that
container
is
full.
Run
initiation
could
result
in
spill.
/
Le
logiciel
de
gestion
des
déchets
et
le
détecte
meration
Kit
(material
no
340498)
failed
to
meet
internal
stability
specifications.
Failure
of
stability
can
result
in
poor
resolution.
/
La
socié
 ont
brisées
pendant
l’insertion.
ithin
the
mars
albumin
circuit.
This
may
lead
to
indirect
loss
of
patient
body
fluid
caused
by
the
albumine
dialysate
loss.
/
La
société
Gamb
  button on 4D console which may in turn be applied to treatment plan. If not observed, mistreatment may occur. / Le thérapeute peut modifie
howed
the
base
curve
to
be
steep,
which
can
cause
vaulting
on
the
eye
and
lead
to
reduced
or
fluctuating
vision.
/
Il
y
a
eu
une
augmentat
he
activity
fine
trim
(AFT)
value.
/
Le
test
poststérilisation
de
EnPulse
indique
par
inadvertance
un
site
incorrect
pour
la
valeur
de
la
finess
 icate
errors,
linearity
flags
and
poor
precision.
/
Deux
numéros
de
lot
du
produit
présentent
une
stabilité
inférieure,
entraînant
des
problè
ed.
The
french
label
was
used
rather
than
the
English.
/
La
mauvaise
étiquette
de
mise
en
garde
sur
laquelle
figure
le
guide
d’entretien
a
é
urostimulator.
/
À
l’intérieur
du
stimulateur
cérébral,
des
fils
de
connexion
brisés
se
trouvaient
entre
la
pile
et
l’électronique
hybride.
 not
one
piece
as
specified.
This
can
cause
the
tip
of
the
punch
to
break
off
during
use.
/
Les
poinçons
n’ont
pas
été
fabriqués
conforméme
 e
an
increased
resistance
to
gas
flow
due
to
an
improperly
manufactured
foam
filter.
/
En
raison
d’un
défaut
de
fabrication
du
filtre
en
mo
 est
result
is
artificially
low.
/
Lorsque
la
prise
de
gentamicine,
de
digoxine,
de
phénytoïne
ou
de
théophylline
précède
celle
de
l’acide
valpr
ery
power.
/
Les
dispositifs
équipés
du
logiciel
V38
peuvent
s’éteindre
sans
avertissement
s’ils
sont
alimentés
par
une
batterie
de
secours
(
  e
redesigned
prior
to
continued
sale
and
sales
of
the
current
version
should
stop.
/
Possibilité
que
le
mousqueton
ne
soit
pas
correcteme
oading
the
Prisma
sets
from
the
Prisma
system
after
disconnecting
the
patient.
/
Le
fabricant
a
eu
connaissance
de
plusieurs
cas
de
fuite
su
  utination
du
latex
sensibilisé
(R1)
avec
le
contrôle
positif
(R3).
 ulation or delay in therapy. / Un condensateur de la mauvaise dimension installé dans le générateur d‟électrochirurgie est susceptible de ma
 t
in
the
device
to
stop
in
an
intermediate
position
and
not
allow
the
device
to
cycle
at
the
next
of
time
of
use.
/
Avertissement
à
l’intentio
e adjusted to improve correlation with the reference method. / De faux positifs ont été observés dans la présentation générique 56. Les v
 ct.

The
incorrect
values
are
7.3
to
12.2
mg/day
but
should
be
72.9
to
121.5
mg/day.
/
Les
valeurs
de
référence
en
mg/jour
de
la
concentr
ange
with
lot
29506m100.

Control
results
outside
the
package
insert
range
would
result
in
an
invalid
run.
/
Il
y
a
eu
un
nombre
croissant
d
OD
printed
on
the
tube
flange.

The
OD
stated
on
the
labelling
is
11.0mm
and
the
OD
of
the
tube
is
actually
11.8mm.
/
La
taille
du
diamèt
 
n’est
plus
conforme
aux
normes.
Des
valeurs
incohérentes
ont
été
signalées.
 es
containing
test
strips
had
correct
lot
number.

Product
safety
and
effectiveness
not
affected.
/
Un
numéro
de
lot
erroné
a
été
attribué

 cy
to
stick
creating
compressor
noise
and
fluctuations
in
driver
flow.
/
Le
matériel
de
la
valve
à
disque
(lot
no
20052904)
utilisé
à
l’intérieu
y
blue
which
can
lead
to
error
messages,
the
remove
test
strip
symbol,
or
inaccurately
low
blood
glucose
results.
/
La
pastille
de
confirma
he
end
of
the
rail
and
fell
to
the
floor.
/
Une
station
de
charge
fixe
est
demeurée
sur
la
position
«
open
»
(ouvert)
alors
que
les
rails
n’étaie
 rousses d‟architecture de formation automatisée 03E48-05 incluent un aide-mémoire (96529-102) contenant des erreurs d‟étiquetage.
nephrectomies
as
the
device
may
become
dislodged.

Devices
to
be
relabelled
with
new
contraindication.
/
L’utilisation
du
dispositif
pour

  res
of
an
entrust
icd
as
enabled
when
they
are
disabled.
/
Dans
certaines
circonstances,
la
première
version
du
système
PaceArt
de
2005

mm
to
4mm.
This
change
causes
some
hubs
to
fracture
due
to
side
impact
or
heavy
weight
leaning
to
one
side
of
walker.
/
Le
déambulateu
 à des tests de stérilité sur des compresses abdominales, 1 unité sur 10 à été trouvée non-stérile.
  
to
read
and
the
subsequent
sample
is
cycled
in
body
fluid
mode.
/
Des
résultats
erronés
peuvent
se
produire
lorsque
des
liquides
organiq
 ely. / Les coupleurs sont bloqués à la fois au cours des chirurgies et des périodes postopératoires. Le mouvement rotatif du coupleur est e
 . / La société Teleflex Medical a constaté que le produit ne répondait pas aux exigences validées du test de stérilité.
 ating of the guide wire. / Le dispositif insertion-introducteur en métal peut endommager le fil-guide en perturbant la couche adhésive de
 a
report
that
could
provide
incorrect
data.
/
Les
résultats
ne
s’affichent
pas
correctement
sur
le
rapport.
Par
conséquent,
le
dernier
méde
  m
reports
an
automated
differential,
the
system
will
show
on
the
final
report
(cumulative)
all
the
different
parameters.
/
L’unité
d’hémat
 
specifies
an
incorrect
location
for
the
activity
fine
trim
(AFT)
value.
/
Le
test
poststérilisation
de
EnPulse,
dans
le
cas
de
trois
numéros
de

 ed.
/
Étiquetage
incorrect.
Des
lames
de
scie
ont
été
étiquetées
avec
le
nom
Profix
Stryker
(ancien
modèle)
au
lieu
de
“Profix
hall
3/4
fann
ns accidentelles.
 se
trigger
can
occur
due
to
particulate
contamination
or
dust.
/
Dans
le
capteur
du
tube
du
carrousel,
servant
à
déplacer
un
tube
de
réacti
t may have connector sockets with short drill depths. / Les dispositifs fabriqués entre octobre 2005 et février 2006 sont munis d‟un raccord d
ng
under
accelerated
stress
testing
with
routine
shipping
configurations.
These
tears
are
potential
breach
of
the
sterile
barrier.
/
La
société
 (3)
possible
image
loss
when
printing,
(4)
study
date
and
time
no
showing
up.
/
Quatre
problèmes
potentiels
ont
été
détectés
:
(1)
un
pro
 
instructions
and
how
to
identify
if
the
instruments
that

are
intended
to
be
disassembled.
/
Fournir
à
tous
les
utilisateurs
actuels
de
ces
p
uator
failed
due
to
wear
and
tear
of
the
brass
pin.
/
Deux
incidents
se
sont
produits
au
Royaume-Uni
au
cours
desquels
le
boulon
reliant
le
  ative
cells
do
not
contain
a
JKA
positive
cell
as
recommended
for
antibody
screening.
/
La
liste
de
contrôle
sur
laquelle
figure
le
lot
de
Pan
 d
the
failure
to
a
loose
joint
between
the
scale
and
hanger
bar,
causing
a
fatigue
failure
of
the
bolt.
/
Une
enquête
menée
sur
un
accident
 
has
been
stored
on
a
Vitros
Chemistry
System
for
more
than
48
hours.
/
Lorsque
le
produit
a
été
conservé
dans
le
système
Vitros
Chemist
assis.
The
manufacturer's
analysis
shows
that
the
castor
fixation
in
the
chassis
was
not
manufactured
as
specified.

/
Deux
incidents
se
son
f the jaw and the tube during laparoscopic procedures. / La société a été informée de cas où les pinces à préhension se sont cassées à la jo
 utches
may
be
defective
and
tips
may
not
lock
into
place
with
crutch
side
pieces
during
assembly.
/
Les
embouts
de
caoutchouc
n’ont
pas
defective
hand
crank's
steel
tip
is
too
big
to
fit
in
the
hole
for
the
hand
crank
in
the
roller
pump
head.
/
La
manivelle
de
la
pompe
à
galet
d
d
as
overlays
on
the
patient
image.
The
Position
of
the
annotation
may
shift
or
the
drawn
lines
may
appear
thicker
after
the
image
is
later
r
d
as
overlays
on
the
patient
image.
The
Position
of
the
annotation
may
shift
or
the
drawn
lines
may
appear
thicker
after
the
image
is
later
r
problème
relatif
à
la
perte
possible
d’images
kette.

When
the
info
from
the
diskette
is
submitted
to
an
external
qc
program,
it
can
cause
a
skew
in
the
means
and
standard
deviation
a
vice
to
remain
on
battery
power
following
a
short
interruption
of
ac
power.
/
Il
existe
une
anomalie
dans
la
conception
du
bloc
d’alimenta
   numéro 01-7172 (coupe-plaques/coupe-fils) peut ne pas entrer dans le contenant.
ntegrated
electronics
cabinet,
excluding
Opart
ultra
system.
/
Un
problème
lié
à
l’amplificateur
de
gradient
peut
survenir
lorsqu’on
utilise
 
problem
relates
to
an
inadequate
mechanical
condition
at
the
holding
frame,
caused
by
inadequate
manufacturing
process.
/
Les
soudur
plet
de
l’emballage
compromet
la
stérilité
du
produit.
 ween
December
2002
and
February
2004.
/
Les
fusibles
du
circuit
d’alimentation
du
détecteur
peuvent
se
révéler
défectueuses
dans
le
ca
 ms
and
antimicrobial
agents
when
MIC
values
are
edited
in
pre
after
ESBL
confirmation
result
stored.
/
Le
fabricant
a
découvert
que
le
log
 d
failure
to
change
the
scan
range.
/
Des
problèmes
de
logiciel
ont
été
découverts
au
cours
de
l’utilisation
du
tomodensitomètre;
ces
pro
  e
l’information
sur
le
patient
au
cours
de
l’étape
du
traitement
des
données
brutes
par
l’appareil.
s
résultats
d’analyse
erronés
en
raison
d’une
quantité
insuffisante
de
thromboplastine.
 /
Le
tube
distal
est
perforé
par
le
mandrin
qui
n’est
pas
complètement
inséré
dans
le
cathéter.
sms
and
antimicrobial
agents
when
MIC
values
are
edited
in
pre
after
ESBL
confirmation
result
stored.
/
Le
fabricant
a
découvert
que
le
lo
  
Le
dispositif
du
signal
sonore
du
haut-parleur
peut
tomber
en
panne
et
empêcher
le
déclenchement
audible
de
l’alarme
en
cas
d’alerte.
st requirements. / La société Teleflex Medical a constaté que le produit ne répondait pas aux exigences validées du test de stérilité.
 ts
could
fall
and
inadvertently
trigger
unit
movement.
/
Il
est
rappelé
aux
utilisateurs
de
ne
pas
placer
d’objets
près
du
dispositif
de
comma
nt été signalés.
y
blue
which
can
lead
to
error
messages,
the
remove
test
strip
symbol,
or
inaccurately
low
blood
glucose
results.
/
La
pastille
de
confirma
t.

The
incorrect
values
are
7.3
to
12.2
mg/day
but
should
be
72.9
to
121.5
mg/day.
/
Les
valeurs
de
référence
du
magnésium
urinaire
en
m
ant
la
«
butée
d’arrêt
»
est
erronée.
 nité
de
commande
du
logiciel
comporte
une
anomalie
:
il
y
a
un
risque
potentiel
de
laisser
tomber
le
casque
du
collimateur.
a
false
negative
result.
/
Les
clients
utilisant
des
flacons
dont
les
étiquettes
code
à
barres
indiquent
un
code
autre
que
bact/alert
courent
le
 ved
OB
report
is
opened
on
the
g40
system.
/
Cette
mise
à
jour
corrige
un
problème
lié
au
changement
de
la
date
probable
d’accouchem
y
that
the
RFPA
may
oscillate.
This
can
result
in
a
wrong
RF
power
measurement
and
subsequently
a
wrong
sar
limit
calculation.
This
could
stem
instabilities.
/
La
mise
à
jour
a
été
effectuée
afin
d’apporter
une
amélioration
au
logiciel
et
aux
connexions
des
câbles
pour
éviter
les
 s
risk
may
occur
when
the
table
is
moved
laterally
and
the
patient
or
user
grasps
the
table-top's
edge
or
underside.
/
Il
y
a
un
risque
poten
écision de la partie inférieure du système a engendré des répercussions à la fois sur les calibrateurs et sur les échantillons des patients do
c
kind
of
short,
the
sensor
may
emit
heat
through
its
leds.
/
Si
le
moniteur
du
dispositif
est
utilisé
avec
un
câble
d’oxymétrie
pulsée
endom
overestimated by more than 2 times the actual value. / Le dispositif peut signaler des résultats du nombre de globules blancs erronés selo
 teurs ne fonctionnent pas parfaitement. Il en résulte une courbe d'étalonnage du dosage erronée.

set.
The
manifold
on
the
sets
may
be
occluded
causing
2
of
the
4
fluid
flow
areas
to
restrict
circulation
of
the
recirculating
warming
fluid.

cted
across
the
range
of
claimed
operating
temperatures
of
15-30
C.
/
Les
résultats
d’hémoglobine
provenant
d’échantillons
prélevés
sur
d
 alues
by
80%
could
be
observed
if
N
Latex
lp(a)
determined
directly
after
homocysteine
with
N
Latex
HCY.
/
Une
sous-estimation
des
vale
 ces
instead
of
the
correct
Legionella
ICT
pouches.
/
La
trousse
du
test
Now
Legionella
Urinary
Antigen
(lot
no
024448)
est
susceptible
de
c
 
cytometry
analysis.
/
L’élément
de
contrôle
de
la
numérotation
des
cellules
Stem
Trol
est
défectueux.
Il
affiche
un
taux
moyen
plus
élevé
pecified
on
the
package
insert.
The
test
result
would
be
interpreted
as
invalid.
/
Le
produit
ne
satisfait
pas
aux
normes.
L’écoulement
de
l’
n
of
a
total
shift
upward
of
18-22%
at
product
expiration
on
11/04/2006.
/
Les
données
démontrent
une
augmentation
des
valeurs
de
l’ord
ncluding localized induration, swelling, inflammation, wound drainage, infection and device migration. / Le produit Calstrux, utilisé en combina
  d
value
after
the
scan
start
button
is
lit,
a
value
outside
the
permissible
range
was
entered.
/
Après
l’activation
du
voyant
lumineux
de
l’in
uantity of dispensers that have male luer tips mixed with the dispensers that have oral tips. / La société Baxa a été avisée que certains lots
 2.2.1
tumour
localization
that
may
lead
the
user
to
misinterpret
the
displayed
data.
/
Deux
états,
relativement
à
la
version
2.2.1
du
localis
t licenced. / Le système Eyelogic est un instrument médical de classe II; par conséquent, une licence doit lui être délivrée. Ce produit ne po
automatically updating the flow rate programmed on the power head. / Le logiciel présente une anomalie : le débit programmé sur la con
 ière sont susceptibles de se dévisser.
d 2006-oct-04 may have a compromised sterile barrier. / La barrière stérile des appareils à aspiration Frazier et Poole, fabriqués par ConM
 rs 38005HW00, 41008HW00, 42063HW00 have been received. / Sept clients ont demandé des renseignements relativement aux défauts
by and 22% higher than reported on the cell-dyn 3200. / La numérotation plaquettaire obtenue pour des échantillons prélevés chez des pa
 s
have
resulted
in
thermal
damage
to
the
humidifier
enclosure.
/
L’humidificateur
chauffant
REMstar
comporte
des
défaillances
du
raccor
 erial
master
pump
and
the
cardioplegia
master
pump
when
intervention
is
set.
/
Une
nouvelle
version
du
logiciel
vient
d’être
lancée;
elle

  t
flex
cable
and
its
connector
on
the
ecg
circuit
board
leading
to
communication
errors.
/
Il
y
a
une
plus
forte
proportion
de
plaintes
assoc
  n-sterile,
which
could
put
patients
at
higher
risk
for
infection
at
the
point
of
application
of
the
skull
pins.
/
On
a
récemment
découvert
un
  oth the acoustic output and patient contact temperature are above specification when the S12-4 is used in cw-mode. / Un problème con
ne
anomalie
potentielle
a
été
détectée
dans
le
sous-système
du
tomodensitomètre.
Celle-ci
influe
sur
l’ouverture
du
collimateur
du
tomo
 
leak
blood.
/
Le
carter
de
centrifugeuse
de
125
mL
de
la
trousse
de
photophérèse
Uvar
XTS
XT125
est
susceptible
de
laisser
du
sang
s’éco
 
fabricant
a
établi
que,
dans
le
cas
de
ces
4
lots
uniquement,
la
stabilité
du
contenu
de
la
fiole
après
son
ouverture
n’est
que
de
5
jours.
the
crutches
may
be
defective
causing
breakage
and/or
the
tops
of
the
crutches
may
not
lock
into
place.
/
Une
installation
défectueuse
de
  ouch Ultrasmart Metres and, when necessary , the metres themselves. / Les piles des lecteurs OneTouch® UltraSmart® étant susceptible

n
patients
in
two
separate
facilities.
/
La
pointe
en
mousse
de
l’applicateur
s’est
détachée
du
bâtonnet
pendant
le
nettoyage
buccal
de
pa
ot
completely
aligned.
During
use
of
the
product,
the
blade
either
falls
off
or
a
piece
breaks
off.
/
À
cause
de
certaines
aspérités
sur
la
lam
 that
ice
water
leaked
through
the
bottom
seam.
/
Le
composant
du
sac
pour
matières
contaminées
compris
dans
ces
dispositifs
peut
être
 s acquired. / La société Toshiba a publié des directives de modification du champ dans une mise à niveau du logiciel afin de préserver les i
after reconstitution. / Les résultats des contrôles et des échantillons pourraient être plus élevés à cause de la déterioration précoce des ca
 xists of torquing tooth in opposite direction than desired. / Le produit a été fabriqué avec un couple de serrage de -7 degrés au lieu du cou
  caps. Recall does not affect already inserted product. Affected lot codes have last four digits less than 1595. / Les capuchons bronze des
ng bd stem cell controls to fail. / Le nécessaire de dénombrement des cellules souches de marque BD peut présenter une mauvaise résolu
 e unexpectedly during electron treatment. / Dans certaines circonstances, les diaphragmes de secours du collimateur multilames des accé
treatment of rectangular electron fields could occur. / Les applicateurs rectangulaires peuvent être associés à des valeurs de diaphragme au
 very
therapy,
blood-back-up
into,
or
loss
of
potency
of,
the
infusion
line.
/
Il
est
possible
que
l’appareil
ne
puisse
détecter
une
occlusion
e
 ycle
is
run
and
the
water
level
is
too
low.
/
Au
cours
du
cycle
de
nettoyage,
il
est
possible
que
le
dispositif
surchauffe.
Ceci
tend
à
se
prod
clenche
pas
en
mode
hors-ligne
sur
commande
de
l’utilisateur.
 que la pochette ne soit pas complètement hermétique.
ies to patients. / Il est possible que le dispositif de positionnement de la table horizontale se déploie trop rapidement, ce qui peut provoq
ixed
with
files
from
other
patients.
Event
2:
possible
incorrect
calculation
and
recording
of
patient
dose.
/
Cas
no
1
:
certains
utilisateurs
o
ese lots. / Bio-rad ne publie plus de valeurs cibles et ne garantie plus la stabilité de l'homecysteine pour ces lots.
r un résultat faux négatif.

ults
that
are
elevated
by
13%
on
average.

Could
cause
physician
to
believe
patient
has
normal
or
peaking
LH
level.
/
Il
est
possible
que
les
products
experiencing
a
vacuum
leak
during
two-year
aging
tests.
/
La
date
d’expiration
du
produit
a
été
ramenée
de
deux
ans
à
un
an,
éta
where
devices
were
stored,
resulting
in
all
products
to
form
glycerol
droplets
on
the
inner
blister
of
the
package.
/
Dans
une
région
extrêm
ion
in
conjunction
with
activating
three
workflows
at
the
same
time
on
the
remote
control.
/
La
fonctionnalité
«
inclinaison
de
la
table
»
n
ed
over
1.5-2.5
years,
and
therefore,
has
the
potential
to
act
as
a
foreign
body
over
an
extended
period
of
time.
/
Rappelez
à
tous
les
clien
ausing
the
bowl's
rotating
seal
to
deteriorate
during
centrifuging,
releasing
particulate
into
the
processing
blood.
/
Il
est
possible
que
les
b
nce.
Key
bounce
occurs
when
a
number
registers
twice
although
the
operator
only
pressed
the
key
once.
/
Le
rebond
de
la
touche
de
tou
 h partial disconnects at u11 on the cpu board and/or the 50-conductor cable connecting the interface and cpu boards. Device provides an a
 tial
for
solutions
from
the
secondary
container
to
pass
the
check
valve
and
enter
backflow
into
primary
container.
/
La
société
Baxter
tran
  the
neck,
one
in
the
wrist.
In
both
instances,
the
persons
fell
down
on
the
outer
arm
of
the
u.
/
Deux
incidents
ont
été
rapportés
:
des
per
 1%
of
the
tim)
impax
returns
a
"no
findings"
message
to
the
user.
/
Lorsque
l’algorithme
CAD
tombe
en
panne
(les
fournisseurs
de
produi
 d/mis-labeled
in
reverse.
Application
of
these
products
in
reverse
order
may
result
in
compromised
bond
strength.
/
Le
primaire
et
l’adhé
 istration
(FDA)
variance
for
mini
6800
digital
c-arm,
variance
number:
00P-1577/CPI.

The
9R/min.
Is
only
exceeded
at
maximum
techniqu
 ic
interface
(valves).
/
Une
fuite
intermittente
peut
se
produire
entre
la
cassette
Aladin
2TM
et
l’interface
pneumatique
(valves)
de
la
stat
pel affiché le 29 mai, 2006.When displaying fused images using high zoom, a shift could occur between ct and pet portions of the images, w
 nitiation
of
a
rapid
stimulation
train
without
command
when
in
use
in
conjunction
with
an
electro
surgical
unit).
/
Certaines
composantes

  s
to
be
misinterpreted.
/
Des
segments
pourraient
manquer
sur
l’afficheur
à
cristaux
liquides
du
glucomètre,
ce
qui
pourrait
entraîner
un
of software being used. / Le fabricant a découvert six problèmes pouvant toucher ces produits, selon la version du logiciel utilisée.
s durant la laparoscopie.
brication, certaines des lames cannelées des limes ont été endommagées.
d
in
the
secondary
bar
code.
When
the
code
is
scanned,
the
expiration
date
appear
to
be
later
than
the
actual
date.
/
Un
format
de
date
d
 cracks
propagate
through
the
pin
cross
section
until
the
pin
breaks,
severely
compromising
the
knee
function.
/
Certains
éléments
du
disp
ons
since
early
2005.
Failure
starts
with
partial
separation
of
outer
tube
at
the
connection
to
female
luer
lock.
/
Augmentation
du
nombre
d
 have
been
implemented.
/
Baxter
procédera
à
la
vérification
de
chaque
instrument
pour
s’assurer
que
toutes
les
corrections
recommandé
 n
states
"yellow-orange
plug."
inconsistencies
between
quality
control
release
specifications
and
product/package
inserts
were
identified
 ent
tables
may
have
defects
in
the
lamination
of
the
plywood.
/
Certains
des
contreplaqués
utilisés
dans
la
fabrication
des
tables
d’exame
 hen
"other"
selected
with
software
V1.0
&
V1.2.
results
could
be
elevated
as
much
as
twice
actual
value.
/
La
fonction
de
détection
et
de

est. / Le message « erreur de calcul » pourrait être mal interprété au cours du dosage de la digoxine.
 emostasis
hub
leakingor
separating
from
the
handle.
There
have
been
a
0.79%
device
malfunction
rate.
/
Le
fabricant
s’est
aperçu
que
l’e
  
only.
/
Défaillance
possible
de
l’alarme
indiquant
la
fin
de
la
perfusion
ou
une
occlusion
au
cours
de
la
perfusion,
en
mode
140
cc
uniquem
 icenced
devices
in
Canada.
/
GC
America
a
été
informée
par
un
de
ses
distributeurs
qu’elle
vendait
des
dispositifs
non
homologués
au
Can
  in
the
instruction
for
use
such
as
last
service
dates,
maintenance
and
inspection
pre/post
operation.
/
Étiquette
de
notification
et
de
mise
   system. / Il est possible que les systèmes Rapidlab 1265 transmettent des valeurs de co-oxymétrie erronées au SIL ou aux systèmes Rapi
anufacturing
specifications,
specifications
did
not
prevent
reagent
from
drifting.
/
Le
taux
de
récupération
associé
aux
lots
de
réactifs
vanc
 he
foil
sealing
occluding
the
pipe
tip.
/
Le
fabricant
a
noté
un
problème
rare,
lié
à
l’obtention
de
résultats
erronés
dus
à
l’occlusion
de
l’ex
te,
the
catheters
may
deteriorate,
possibly
causing
leakage
or
breakage.
/
Si
le
produit
est
rincé
ou
liquéfié
à
l’aide
d’une
solution
d’éthan
 ns
7.2.2
REL
2,
7.2.2
REL
4A,
7.2.2
REL
5
and
7.3.
/
Il
arrive
que
l’on
obtienne
une
valeur
plus
élevée
que
la
normale
à
l’indice
de
captation
n
of
the
tubing
with
harmful
effect
on
blood
components
and
risk
of
haemolysis.
/
L’enroulement
de
la
tubulure
en
cours
de
traitement
pe

mitted
fluid
to
enter
electrical
enclosure.
This
condition
could
cause
a
thermal
damage
to
the
machine.
/
Le
boîtier
électrique
des
réchauffe
 be
exposed
to
the
sterilized
field
of
the
drive
system.
/
L’aiguille
d’enclenchement
arrière,
non
stérile,
peut
atteindre
le
champ
stérile
du
s
 ,
P2C
and
P10C
made
with
orthophos
XG
Plus
and
orthophos
XG5,
erroneous
measurements
can
occur.
(Www.sidesix.com).
/
Si
aucune
m
 onitoring
manifolds
and
"NORY"
ultra
filtration
removal
regulators
to
crack
due
to
mechanical
and
thermal
stress.
/

Le
fabricant
s’est
ape
 ithin
the
compromised
outer
tyvek
pouch
may
not
be
sterile
and
may
contaminate
a
sterile
field
during
surgery.
/
Il
se
peut
que
la
pochet
 the
rollers
may
detach
from
the
ceiling
rails
which
may
cause
the
teleskop
carriage
to
loosen
and/or
fall.
/
Le
dispositif
doit
être
correctem
 ctions
are
not
followed.
This
may
cause
the
rollers
to
detach
from
the
ceiling
track.
/
Si
les
directives
d’entretien
préventif
ne
sont
pas
sui
 el
d’isolation
des
filaments
de
chauffage
soit
endommagé
:
il
existe
donc
un
risque
d’incendie.

 es
registered
in
the
leksell
gamma
plan.
/
Le
logiciel
n’avertit
pas
l’utilisateur
lorsqu’il
importe
des
images
de
deux
patients,
dont
les
nom
omized and saved before a scan and contain a 3D recon job) was automatically changed to 0.45 or higher, which can affect the scan result
proper
seal
between
the
vial
and
the
lid
potentially
leading
to
a
wrong
result.
/
Il
se
peut
qu’un
ruban
de
plastique
se
trouvant
sur
le
dessu
  
check
flange
alarm,
Baxter
is
sending
an
addendum
for
the
operator's
manual
on
downstream
occlusion
issue.
/
En
mai
dernier,
Baxter
a
cence#
66832.
Verify
products
on
www.mdall.ca
and
contact
your
supplier
if
your
stock
is
affected
by
this
recall.
/
La
poche
pourrait
ne
pa
a
hazard.
/
Il
est
possible
que
l’isolation
électrique
ait
été
endommagée
durant
la
production,
ce
qui
peut
représenter
un
danger.
  esults
that
do
not
match
runtime
results.
/
Le
logiciel
peut
produire
le
message
d’erreur

«
Out
of
memory
»
(mémoire
insuffisante).
La
co
 les
above
300
mg/ml
and
false
negative
results
for
marginally
positive
urine
samples.
/
Le
fabricant
a
confirmé
que
la
vitesse
de
réaction
a
  formation
of
a
viscous,
amber-coloured
material
in
the
diluent
which
may
prevent
the
complete
hydration
of
the
chrome
tablet.
/
Les
rés
ay
fall
out
of
the
product
container
and
be
missing
at
the
time
of
use.
/
Il
est
possible
que
les
instructions
se
trouvant
dans
le
tube
métalliq
s tiges de blocage peuvent se desserrer et se détacher : les deux parties de la civière se séparent.
  Une seule décharge laser a été émise par le laser C6 au cours de la période de réchauffement de 2 minutes.
 is
applied.
Instruction
for
use
is
misleading
as
it
only
mentions
do
not
lubricate
slides.
/
Si
les
vis
ne
sont
pas
fixées
solidement
dans
la
cou
udden decrease in altitude, which may cause a delay in obtaining the defibrillator when needed. / La mallette pourrait renfermer un orifice de
ment ou écaillage de la peinture de la poignée ou autour de celle-ci. Plastique de la poignée fendu.
d
may
burn
out,
emitting
smoke,
a
possible
observable
burst
of
flame
as
board
ceases
to
operate.
/
Le
fabricant
a
établi
que
la
dissipation
 ted
bonding.
/
Adhésif
dentaire.
Les
adhésifs
d’un
lot
avaient
des
concentrations
faibles
en
initiateur
de
photopolymérisation,
ce
qui
peut
4.
/
Les
lames
de
taille
20/04
ont
été
récupérées
malencontreusement
avant
l’assemblage
:
elles
ont
été
assemblées
comme
des
40/04,
so
 h were observed for the low, medium & high controls when the calibrator lot 33376Q10 was used as the reference. / Des tests effectués
 ains the other one (Profix posterior # 71522260 LOT:05dm07266). / Erreur de conditionnement. L’étiquetage
extérieur
mentionne
un
pro
rting
the
input
and
output
connections
to
the
device
air
vent/bubble
trap.
/
On
s’est
aperçu
que
le
dispositif
jetable
présentait
un
défaut
d
e
pc
monitoring
console
with
a
resulting
discrepancy
between
the
recorded
real
irradiation
times
and
the
recorded
times.
/
Erreur
de
com
 facturing
for
it
to
be
able
to
pass
through
the
working
channel
of
a
scope.
/
Le
diamètre
extérieur
du
dispositif
a
atteint
une
dimension
su

et
de
la
plaque
d’appui
tibiale
 
patients
could
not
thread/connect
the
stay
safe
patient
connectors
(trigger)
to
their
pd
transfer
extension
sets.
/
Depuis
le
7
mars
2006,
F
 h
format
instead
of
month/year
.
If
this
code
is
scanned,
the
expiration
date
will
appear
later
than
actual
date.
/
Un
format
de
date
de
pé
  removal. / La solidité du cathéter peut se trouver compromise et entraîner la rupture du dispositif pendant son retrait.
 
the

poly
pouch
package,
thereby
potentially
compromising
the
sterility
of
the
device.
/
Il
est
possible
que
le
capuchon
protecteur
de
l’ex
vessels
with
implanted
stents
of
twelve
complaints,
surgical
intervention
was
required
for
seven
patients.
/
Recommander
aux
clients
de
r
 e les résultats soient erronés lorsque la base de données du poste de travail tombe en panne.
at
installation
subcontractors
had
used
the
wrong
screws
to
attach
the
detector
during
installation.
/
L’entretien
a
révélé
que
certaines
vis
s
nsert
directs
customers
to
freeze
samples
if
assay
will
not
be
completed
within
48
hours,
or
for
shipment
of
samples.

/
Après
la
congélati
 e
formée
par
le
sac
d’emballage.

cified
with
the
current
method,
but
new
lots
must
be
used
with
an
updated
method
to
perform
effectively.
/
Le
changement
de
matière
p
 erility
of
the
product.
/
Une
anomalie
de
l’étanchéité
de
l’emballage
risque
d’entraîner
la
dégradation
du
fil
de
suture
et
de
compromettr
ramic capacitors was identified. / Risque de déchargement prématuré de la batterie des dispositifs fabriqués avec certains condensateurs cé
 e
patient
from
the
foam.
/
Le
dépliage
du
dispositif
peut
s’avérer
difficile
et
se
traduire
par
la
déchirure
de
la
couche
non-adhésive
qui
pro
e
trap,
which
may
allow
air
to
pass
through
trap,
bypassing
auto-venting
mechanism,
potentially
reaching
patient.
/
Il
se
peut
qu’un
nomb
ap to the carry bar. / Nombre limité de sangles à quatre couches au lieu de trois au niveau de la boucle qui joint la sangle lève-personne à
 ted
and/or
may
demonstrate
a
delayed
or
decreased
reactivity
with
some
homogenous
strains
of
quality
control
antigens.
/
La
performan
 
s’est
aperçu
que
la
date
de
péremption
figurant
sur
l’emballage
de
ce
produit
était
erronée.

he
calibrator
package
insert
that
accompanied
this
lot
of
material.
/
Un
avis
a
été
émis
à
l’attention
des
clients
parce
qu’une
erreur
d’unité
 to
CBC/diff
selectivity
mode,
the
instrument
can
produce
false
low
results
on
first
sample
tested.
/
Les
tests
réalisés
par
le
fabricant
ont
co

tigate
the
risk
of
complication
due
to
tissue
erosion.
It
was
sent
twice
to
end
users
(January
and
may
2006).
/
Le
2
janvier
2006,
Aga
a
émis
                                                                                         L’orientation
de
l’image,
des
marqueurs
et
des
anno
e
fuji
CT
image
processing
algorithm
is
applied
after
rotating
or
flipping
a
CT
image.
/



otavirus detection in faeces. / La baisse de sensibilité du Slidex Rota-Kit pourrait se traduire par des résultats faussement négatifs pour la re
acturing
change
that
introduced
variability
in
the
length
of
the
inner
stylet.
Exposed
stylet
length
may
be
up
to
8mm
longer
than
expected
 t program change" date beginning January 1, 2003, software had outlasted their expected design life of 16 years. / Le logiciel a été mis à jo
  eucocytes on strips used with Bayer Clinitek 100 and 500. / Avec le niveau 2 du produit quantify control, lot 78512, on rapporte des valeu
une interprétation faussement positive ou négative
ng
transseptal
puncture
procedures
which
the
system
changes
from
a
live
image/record
mode
to
an
image
review
mode.
/
Il
existe
un
risq
  urcentage des gaines d'introduction 9Fr a été expédié aux États-unis avec une gaine de 10Fr.
  his
device.
/
Afin
d’améliorer
ce
dispositif,
la
société
Baxter
à
commencé
à
envoyer
des
pompes
comportant
de
nombreux
changements
à
  n cas de perte des images, répétez la procédure de formation des images. Ceci pourra retarder légèrement le diagnostic.
down
of
the
cool-tip
rf
generator
in
ablation
mode.
/
Mode
de
panne
possible
:
la
surchauffe
pendant
la
phase
de
sortie
du
clamp
peut
aff
 ived
two
copies
of
page
2,
and
no
copies
of
page
1
of
the
instructions
for
use.
/

     Dans
certains
cas,
il
manque
une
page
avant
la
page
2
du

  s
to
be
misinterpreted.
/
Des
segments
pourraient
manquer
sur
l’afficheur
à
cristaux
liquides
du
glucomètre,
ce
qui
pourrait
entraîner
un
  cal
flow
and
product
performance
during
defibrillation.
/
La
feuille
d’étain
à
l’intérieur
des
électrodes
triangulaires
peut
se
fissurer,
ce
qu
 entially
resulted
in
breach
of
the
sterile
barrier.
This
recall
is
not
a
result
of
device
functionality.
/
Dans
le
cadre
d’une
mise
à
l’épreuve
pér
 ter
pouch
could
be
compromised
and
there
is
a
potential
that
the
outer
pouch
will
not
maintain
a
sterile
barrier.
/
La
surface
de
la
pochett
  
platelet
background
readings
on
the
cell-dyn
4000
and
cell-dyn
sapphir
systems.
/
L’interaction
de
traces
de
composés
organiques
avec
l
erent
than
the
patient/exam
shown
on
the
diagnostic
display
screens.
/
Le
patient
et
les
résultats
d’examen
qui
ont
été
sélectionnés
pour
on
results
low
were
observed
for
the
high
control.
/
Dans
le
cadre
d’un
essai
en
cours
de
fabrication
mené
sur
le
lot
37648Q100
du
réactif

which
also
disables
the
touch
guard
safety
measures
on
the
x-ray
tube
and
the
image
intensifier.
/
Un
court-circuit
dans
le
câble
du
tableau
orksheets.
when
first
isocenter
is
unmarked,
the
shifts
between
isocenters
printed
on
worksheet
are
incorrect.
/
Une
anomalie
a
été
déce
  
information
from
their
bar
code
labels.
System
software
is
then
unable
to
track
how
long
a
reagent
kit
has
been
stored.
/
Les
étiquettes
à
 
been
re-sterilized
or
reprocessed
prior
to
the
case.
/
Il
est
possible
que
la
gaine
thermorétrécissable
se
retire
de
la
pointe
du
dispositif.
Lo
 d
to
misplaced
annotations.
/
Un
problème
a
été
décelé
dans
le
système
d'archivage
et
de
transmission
d’images
par
la
technique
multico
 aged
on
their
stomach
(posterior-anterior).
/
Des
problèmes
de
mise
en
place
des
étiquettes
d’orientation
peuvent
survenir
sur
la
fiche
po
 la chaise est fixée sur son socle peut casser et, ainsi, faire basculer la chaise.
  ct.
/
L’emballage
stérile
peut
comporter
des
piqûres,
ce
qui
peut
nuire
à
la
stérilité
du
produit.


 
in
potential
contact
between
the
drain
fluid
and
inlet
fluid.
/
Une
défectuosité
dans
la
membrane
d’échange
de
chaleur
peut
en
provoque
 eading with a patient sample. / Ce lot de cartouches EG7+ pourrait provoquer une lecture erronée du sodium ionisé et (ou) du calcium ionisé
 e
lower
impedance
may
lead
to
lower
EMG
signals.
Procedures
that
rely
on
standardized
emg
signals
may
be
affected.
/
À
cause
d’un
défa
 es ont été mal assemblées : des seringues multidoses ont été fournies à la place de seringues unidoses.
n
as
intented.
/
Une
expérimentation-maison
a
permis
de
conclure
que
les
dérivations
de
l’humeur
aqueuse
avec
valves
pour
traiter
le
gla
dvertently
placed
one
lot
number
(418483)
into
saleable
inventory
which
was
subsequently
sold.
/
Après
un
rappel
en
2005
(numéro
de
ré
aged
on
their
stomach
(posterior-anterior).
Software
update
resolves
an
error
with
VB22G/J
software.
/
Il
est
possible
qu’il
y
ait
un
problèm
 aged
on
their
stomach
(posterior-anterior).
/
Il
est
possible
qu’il
y
ait
un
problème
avec
les
étiquettes
d’orientation
sur
la
fiche
post-traite
es.
This
service
pack
1
provides
a
software
patch
to
correct
this
issue.
/
Une
erreur
peut
survenir
lorsque
le
programme
d’examen
pulmon
e
is
intermittent
and
random
lock-up
of
the
system
host
computer.The
system
must
be
rebooted
to
be
operational
again.
/
Une
lettre
d’av
 CG
assay
when
architect
B12
tests
are
run
on
the
same
module.
/
Dans
certaines
conditions
d’utilisation,
un
résultat
faussement
élevé
du
 ection
of
downstream
occlusion.
/
Lorsque
les
pompes
sont
utilisées
à
un
faible
débit
avec
des
seringues
à
grand
volume,
un
délai
peut
su
n. / Si les côtés du lit ne sont pas suffisamment ouverts et relevés, ils risquent de rester coincés en position relevée.
m right branch (left subclavian) may be in reversed order relative to the product specification. / La raison du rappel concerne la branche g
gh
when
using
the
CK-MB
assay.
/
Des
plaintes
de
consommateurs
ont
été
reçues
à
l’effet
que
les
solutions
témoins
de
Abbott
ou
d’autre
 o-Triac needs to be replaced by a more reliable component to be provided by Gambro. / La défaillance du Opto-Triac peut entraîner une
y
detach
from
the
instrument
during
use.
/
Une
pince
en
forme
de
C
près
du
raccord
rugueux
à
l’extrémité
de
l’instrument
a
été
retirée,
c
d
cause
false
positives
in
serological
testing.
/
En
attente
des
résultats
de
l’enquête
pour
déterminer
si
les
lots
#als
10
et
11
de
la
solution
A
 t can cause a loss of sterile integrity. / Il y a un faible risque (moins de 0,05 %) de fissure dans l'emballage-coque principal, susceptible de
  that could cause an air emboli condition when the tubing is not entered in the clamp. / Le fabricant a mis en évidence le risque potentiel
umin,
Urine
Transferrin
or
Urine
Immunlglobulin
G
is
not
affected
by
Alpha-1-Microglobuline
component.
/
L’instabilité
du
lot
M411138
a
 indiquent que le cathéter se brise à environ 1 pouce (2,5 cm) de l‟extrémité.
ts
were
reported
relating
to
broken
baskets.
The
joint
strength
of
device
was
not
meeting
validation
requirement.
/
Ce
rappel
est
diffusé
e
 
that
could
cause
an
air
emboli
condition
when
the
tubing
is
not
centred
in
the
clamp.
/
Le
fabricant
a
mis
en
évidence
un
risque
potentie
ntial
of
an
interruption
of
the
sealing
cycle
which
could
result
in
an
incomplete
vessel
seal.
/
Le
générateur
Ligasure
peut
ne
pas
reconnaît
 lt
in
loss
of
images.
/
Le
paramétrage
incorrect
de
la
règle
de
la
suppression
automatique
et
de
la
règle
du
transfert
automatique
dans
le

 arious profiles, Baxter has decided to conduct a controlled removal from the customers. / Le fabricant a reçu des rapports signalant des p
 t
le
produit
Curix
Ultra
UVL
portent
une
étiquette
erronée
indiquant
qu’elles
contiennent
le
produit
Cronex
10T.
erate
patient
result
errors.
Customers
using
this
lot
have
reported
calibration
several
error
codes
for
samples.
/
Une
augmentation
du
nom
 e
calibrator
volume
field
of
the
assay
configuration
files.
/
Dans
certaines
conditions,
le
logiciel
du
système
attribue
une
valeur
par
défaut
each level. / Le lot 25525Q100 a été mis sur le marché à des concentrations trop faibles par rapport à la cible pour chaque niveau.
  to the laboratory information system, and delay the management of the patient. / Une corruption de la base de données du bact/view pourra
 contaminated with Ralstonia PicketII. / Le fabricant a établi que les lots de sachets dont les numéros sont indiqués contiennent un réactif
e
used
to
calibrate
from.
/
Le
fabricant
a
établi
que
ce
lot
de
tubes
d’étalonnage
comprend
un
tube
qui
ne
devrait
pas
être
utilisé
pour
effe
  otentially
compromising
the
sterility
of
the
devices.
Recalled
burs
have
expiry
dates
between
May
2008
and
November
2010.
/

L’emballag
 L77
analyser
utilizing
a
Calpack
from
identified
lot
number.
/
L’analyseur
ABL77
indique
une
PO2
élevée
lorsqu’un
contrôle
de
qualité
de
n
mode.
Refer
to
operations
manual
and
deal
with
spillage
before
continuing
therapeutic
use.
/
À
la
suite
d’un
renversement
de
liquide,
l’ala
 risque que le patient soit exposé à un courant électrique de surface.
un
24
hr
after
collection
may
yield
erroneously
high
rdw
and
m0%
and
erroneously
low
gr%.
/
L’appareil
ne
remplit
pas
ses
promesses
au
c
 emain
in
storage
for
an
extended
period
of
time.
/
Au
moment
de
l’activation,
un
ralentissement
du
débit
d’oxygène
peut
se
produire
dan
   cause a fire. In this event, there would be no risk of false results as the device would stop working. / Un dissipateur de chaleur situé sur l
 
and
provide
a
root
cause
for
the
insignia
and
nexus
"Failure
Mode
2".
/
Fournir
un
résumé
relatif
à
la
défaillance
du
premier
mode
fonctio
dication.
This
potential
inaccuracy
may
not
be
detectable
to
the
user.
/
La
variabilité
des
méthodes
de
fabrication
de
la
sonde
de
pression
ches
brisées
dans
le
connecteur
désactivent
l’appareil.
  This
could
lead
to
an
inoperative
status
and
not
ready
in
an
emergency.
/
Les
fils
de
connexion
des
composants
peuvent
se
raccorder
de
f
elf
as
premature
battery
drain
of
the
device.
/
Les
plaquettes
de
circuits
imprimés
peuvent
être
contaminés
par
une
croissance
dendritique
 period of 5 days, not 16 days. / Suite à une étude interne, il a été déterminé que le produit, une fois ouvert, restera stable pendant 5 jour
eriod.
Changes
in
the
phosphorus
and
triglyceride
values
after
10
months
of
dating
will
cause
shifts
in
Quality
control
and
results.
/
Deux
lo
e
to
operate
resulting
in
a
power
failure.
/
La
capacité
d’immersion
sur
la
carte
d’alimentation
ne
fonctionne
pas
comme
prévu
et
la
carte

nels
to
separate,
causing
a
bulge
in
the
blanket
that
could
possibly
shift
a
small
patient's
position.
/
La
couverture
ne
libère
pas
suffisamme
 
affects
the
"indications
for
use"
section.
/
Le
dispositif
a
été
expédié
dans
un
emballage
contenant
les
mauvaises
directives
d’utilisation.
C
eady set blood tubing set code K3-9692/9793. / Des fuites ont été signalés entre le raccord de la ligne artérielle et la tubulure dans le cas d
 dpiece.
They
are
used
on
Conmed
Linvatec,
hall,
Versipower
and
Versipower
plus
handpieces
or
sold
individually.
/
L’écrou
de
la
virole
de
eading
to
unsterility.
/
Des
tests
d’expédition
réalisés
à
l’interne
indiquent
que
pendant
l’expédition,
l’emballage-coque
peut
être
endomm
 city CR 2.X.XX can fail. Images can also be deleted from QS when QS approaches 90% of capacity. / La transmission des images entre le nu
 
25
days
without
a
shut
down.
/
L’utilisateur
peut
obtenir
des
images
visiblement
corrompues
lorsque
l’appareil
a
fonctionné
sans
arrêt
d
ng
to
the
magnet
bore.
Where
the
horizontal
table
gap
was
checked,
all
systems
where
the
gap
is
out
of
tolerance
have
to
perform

the
up
 io when attached via vpn. Navigator cut lines for ct are off by 2-4cm on the scout image, and syngo viewing studio not able to load images w
here
are
problems
with
the
intellipoint
mice
software
(middle
mouse
button
and
interactive
windowing
does
not
work.
/
Les
coupes
du
lo

(then
statements)
based
on
prior
sample's
data
(within
any
if
statement).
/
Les
commentaires
portant
sur
l’analyse
des
données
de
la
pop
P
Ver
2.0,
the
MXP
software
will
lock-up
when
running
an
auto-setup
panel.
/
Lorsque
les
versions
1.1,
2.0
et
2.1
du
logiciel
d’analyse
CXP

  Il se peut que la micro-électrode continue de se déplacer même après avoir relâché la pression sur le bouton de la télécommande.
ference
line
will
negate
compensation
for
cyclotorsion
on
customcornea
procedures.
/
En
raison
d’une
erreur
de
logiciel,
l’utilisation
de
la
sulting
in
the
device
not
recognizing
that
battery
power
is
available.
/
La
tension
de
la
batterie
peut
être
interprétée
comme
si
elle
était
inf
 e l'activité de l'alanine aminotransferase au cours de la durée de vie des lots.
 tion
of
syringe
size.
May
result
in
up
to
50%
overdose
of
any
drug.
/
Une
défaillance
de
la
pince
du
corps
de
la
seringue
permet
à
celle-ci
d
knee
from
some
patients
and
doctors.
/
Certains
lots
de
Neovisc
font
l’objet
d’un
rappel
en
raison
du
signalement
par
certains
patients
et

 rly
onto
the
handle
of
the
surgical
scissors.
There
was
potential
for
the
scissor
blades
to
disengage
during
use.
/
TNCO
a
avisé
Pilling
Weck
  100s
Systems.
There
is
a
chance
that
tiny
droplets
of
hydrogen
peroxide
could
fall
onto
sterilization
load.
/
Un
contact
superficiel
avec
de
rors.
/
Le
lot
M51219
du
réactif
AMM
peut
faire
échouer
l’étalonnage
en
raison
d’erreurs
*graves
du
lecteur
optique.

 e
recoveries
that
are
falsely
increased
by
up
to
27%.
will
affect
both
controls
and
patients'
samples.
/
Le
réactif
CRPH
du
lot
M505223G
pe
  le.
If
exported
to
treatment
system,
mistreatment
may
occur.
Verify
mlc
definition
prior
to
treatment.
/
Lorsque
l’appareil
brainlab
mld
n’e
t
is
8mm
x
60mm
instead
of
the
correct
6mm
x
60mm
indicated
on
main
box
product
label.
/
L’étiquetage
supplémentaire
sur
le
côté
des

  er
and
there
is
a
potential
for
patients
to
mismanage
diet
and/or
medication
and
have
periods
of
low
blood
sugar.
/
Les
unités
de
mesure
he
PCA
circuit
simulating
repeated
pressing
of
the
PCA
button.
/
Le
fabricant
a
reçu
plusieurs
rapports
selon
lesquels
un
court-circuit
dans
 potential
to
create
a
breach
in
the
sterile
pathway
within
the
cassette
and
risk
of
bacteeremia
to
donors.
/
Le
fabricant
a
reçu
des
rapport
 to
bowel
perforation
and/or
chronic
enteric
fistulas.
/
Davol
a
reçu
plusieurs
plaintes
concernant
la
rupture
de
la
l’anneau
de
maintien
au
 
date
de
péremption
mentionnée
sur
l’étiquette
est
«
juin
2007
»
au
lieu
de
«
juillet
2007
».
natural health stores. These are class III medical devices. Domestic manufacturers are also unlicensed. / Les autorités sanitaires de Fraser,
ead
to
a
false
negative
result.
/
Le
risque
de
confusion
entre
les
flacons
de
réactif
R2
et
de
troponine
T
pourrait
mener
à
l’obtention
d’un
r
rush
with
bacterial
flora
prior
to
acquiring
the
sample
during
biopsy
procedure.
This
may
result
a
mis
diagnosis.
/
Les
brosses
endoscopiqu
 rnes
ont
révélé
un
risque
de
rupture
du
dispositif
de
soulèvement
du
patient,
susceptible
d’entraîner
la
chute
de
la
table.

 héter
mentionnée
sur
l’étiquette
de
l’emballage
indique
«
6
fr
»
au
lieu
de
«
7
fr
».
 oading
the
Prisma
sets
from
the
Prisma
system
after
disconnecting
the
patient.
/
Le
fabricant
a
eu
connaissance
de
plusieurs
cas
de
fuite

  ly
is
made
from
natural
rubber.
/
L’étiquette
du
produit
indique
«
sans
latex
»
alors
que
le
ruban
adhésif
utilisé
pour
maintenir
les
deux
m
1, 2005. Could result in exposure of the underlying polypropylene mesh and result is adhesions and fistulas. / Un niveau inacceptable de d
y
cause
some
samples
to
be
incorrectly
noted
as
a
false
negative.
/
Les
trousses
de
dépistage
de
l’antigène
de
surface
de
l’hépatite
B
(AgH
ts
were
reported
relating
to
broken
baskets.
The
joint
strength
of
device
was
not
meeting
validation
requirement.
/
Ce
rappel
est
diffusé
e
protéiques
spécifiques
ne
sont
pas
conformes
à
l’allégation
de
57
jours
de
stabilité
des
réactifs
intégrés.
disconnect
caps
to
be
a
contributing
factor
in
changes
in
thyroid
function
of
ESRD
patients.
/

Le
fabricant
a
découvert
que
la
povidone-iod
ntain
microbore
female
lures
that
may
crack
during
with
a
potential
for
leakage,
incomplete
delivery
of
medication.
/
Le
fabricant
a
détect
 îner
un
mauvais
diagnostic
de
l’état
d’un
patient.
 ,
it
will
result
in
a
reduction
in
intensity
potentially
leading
to
inappropriate
exclusion
for
treatment.
/
Une
erreur
de
formulation
du
réact
  aptateur
comportant
des
défauts
de
fabrication
pourrait
laisser
pénétrer
l’air
ambiant
dans
la
chambre
de
mesure.
ors
that
connected
the
transformer
to
the
circuit
board.
/
Les
connecteurs
reliant
le
transformateur
à
la
carte
de
circuits
imprimés
étaient
  diées aux distributeurs.
  002
lot
10273K.
The
product
contents
are
appropriate
and
will
not
change
intended
use
or
cause
erroneous
results.
/
Trente
trousses
tém
time
panel
report
in
CXP
Cytometer
software
ver
2.0.
/
Dans
certaines
conditions,
une
mauvaise
identification
du
tube
(code
à
barres)
peu
 nce specifications for drift in the initial period (first two or more calibrations). / Au cours de la période initiale (durant les deux premiers é
 or
inaccuracy
and
quality
control
and
patient
results
may
shift
high
or
low
with
a
varied
magnitude
and
error
message.
/
Le
fabricant
a
dé
tem's
EDA
accessory
to
not
register
an
in
range
patient
baseline,
resulting
in
a
message
of
''EDA
inoperable''.
/
Si
deux
condensateurs
sont
  ite
2000
causing
a
false
elevation
in
observed
estradiol
concentration.
/
Seul
le
réactif
de
ce
lot
de
trousses
a
été
fabriqué
avec
une
matiè
shock.
The
cleaner
was
not
harmed.
/
Un
préposé
au
nettoyage
a
reçu
un
choc
électrique
en
touchant
avec
un
linge
humide
le
connecteur
or
pad
label
and
posterior
pad
label
located
in
reverse
which
may
result
in
reversing
pad
placement.
/
Correction
volontaire
pour
régler
un
d and the board may burn out, emitting smoke, a possible observable burst of flame as the board ceases to operate. / Le fabricant a établi qu
28 instances. Investigation determined that 11 defibrillators with reworked boards had been released for sale. / Le fournisseur de carte m
 labelled diameter of 12 mm. / On a rapporté que certaines des unités du lot en question mesurent 10 mm alors que leur étiquette indiqu
zard.
/
La
polarité
inversée
du
condensateur
de
l’imprimante
peut
entraîner
une
surchauffe
et
représenter
un
risque
d’incendie
potentiel.
ts
peut
être
bloquée
au
niveau
de
l’embout.

ected
alarm,
gearbox
wear,
under
infusion
and
non-detection
of
upstream
occlusion.
/
Baxter
a
détecté
d’autres
problèmes
:
charge
insuff

over
time.
/
On
a
signalé
que
des
soudures
fissurées
de
la
tige
en
deux
pièces
pourrait
causer
au
fil
du
temps
l’effondrement
et
la
rotatio
 mprécision
totale
des
valeurs
obtenues
au
cours
d’une
analyse
du
S
DHA
exécutée
au
moyen
de
la
plateforme
DXL
dépasse
celles
qui
figu
samples
that
are
run
as
cbc
only.
The
value
0.00
should
not
be
transmitted
as
diff
parameters.
/
En
mode
de
transmission
variable,
l’Act
5
diluted sample into one pre-dilution well and cause overflowing wells and contaminate adjacent wells. / Le logiciel comporte une erreur p
 nically
significant
high
readings
of
glucose
and
lactate
results.
/
Le
message
d’erreur
1.08
(cartouche)
indique
qu’une
lecture
de
référence
new
patient
registration
step
before
starting
a
few
measurement
procedure
on
the
next
patient.
/
L’estimation
du
poids
fœtal
sera
inexac
  wn.
/
Certains
appareils
Vapotherm
ont
été
contaminés
par
des
espèces
Ralstonia,
d’origine
inconnue.
timated and not invalidated, in this situation the wbc optical count may be identified as kinetic optical count. / Le fabricant a remarqué qu
 rodes ont été raccordées transversalement.
 em
distal
shaft
separations
involving
patients.
As
a
result,
three
patients
underwent
coronary
bypass
surgery.
/
La
société
a
été
informée

 in
the
solution
were
showing
weak
microscopic
spontaneous
agglutination
and
weak
false
positive
dat
results.
/
Le
rappel
a
été
émis
pour
f
the
device
to
successfully
deliver
the
intra
ocular
lense
into
the
capsular
bag.
/
Seize
plaintes
émanant
de
neuf
consignataires
différents
o
 eated
during
use.
Consumers
complained
of
discomfort
during
use
and
several
reported
redness/blistering
of
the
skin.
/
Omron
healthcar
 r,
the
Onetouch
Basic
metre
has
a
75
test
record
capacity.
/
Le
manuel
de
l’utilisateur
précise
que
le
lecteur
Onetouch
Basic
a
une
capacit
hin the kit may not meet manufacturing standards. / La charge microbienne de certaines fioles de l'anticorps monoclonal HSV de Type 1 d
 er sheath on certain lots manufactured prior to march 10, 2004. / Boston Scientific a remarqué un détachement de la fixation entre la cap
 t
can
cause
a
loss
of
sterile
integrity.
/
Il
y
a
un
faible
risque
(moins
de
0,05
%)
de
fissure
dans
l’emballage-coque
primaire
susceptible
de
c
  hs
with
cracked
hubs/handles
or
improper
peeling
during
use.
This
product
is
included
in
Boston
devices.
/
Le
fabricant
a
été
informé
que
sequently
died,
to
heighten
clinical
awareness
of
the
potential
consequences
of
such
an
unintended
connection.
/
Communiqué
diffusé
à

e
for
image
orientation
labels
to
be
incorrect.
/
Lorsque
deux
applications
du
produit
(réflexion
et
capture
secondaire)
sont
utilisées
simul
 
applied
to
the
slit
in
the
upper
seal
of
the
valve
boot.
/
Le
fabricant
a
reçu
des
rapports
indiquant
qu’une
lubrification
insuffisante
de
la
fe
he
infusion.
/
Les
utilisateurs
pourraient
appuyer
par
inadvertance
sur
la
touche
de
mise
sous/hors
tension
(«
on/off
»)
au
lieu
de
la
touch
s and have a potential to compromise the performance of the pump. / Le fabricant a reçu des plaintes concernant un gonflement, une sur
  
cause
leakage
of
medication
or
incomplete
delivery
of
medication.
/
Les
produits
correspondant
à
ces
codes
de
produit/à
ces
numéros
d
 nt
and
air
could
reach
patient,
with
extremely
low
flow
rates
if
an
occlusion
occurs
upstream
of
the
occlusion.
/

Le
fabricant
a
mis
en
évid
ous
administration
of
50ml
propofol.
/
Baxter
a
reçu
des
questions
de
ses
clients
sur
la
manière
adéquate
de
préparer
le
dispositif.
Les
clie
  otential
to
allow
the
patient's
blood
to
be
drawn
up
into
the
tubing.
/
Les
tubulures
d’entrée
et
de
sortie
de
la
cassette
peuvent
être
inver
ning
to
the
magnet
bore.
The
gap
between
the
patient
table
top
and
the
covers/
body
coil
will
be
checked.
/
Un
mauvais
alignement
de
la

  n
of
the
offset
for
the
aiming
device
in
breast
biopsy
procedures.
/
Informer
nos
clients
qu’il
est
possible
que
le
calcul
de
la
déviation
du
d
 
/
Après
l’installation
du
logiciel
LX
4.5,
il
est
impossible
de
mettre
à
jour
le
réactif
défini
par
l’utilisateur.
 g
with
negative
serum
patient
samples
for
HCG.
/
Le
fabricant
a
établi
que
la
trousse
de
réactif
identifiée
pouvait
donner
un
résultat
fauss
  ging.
In
2003,
there
was
a
change
in
foil
material
and
dimension
of
foil
pouch.
/
La
stérilité
des
agrafes
à
ligature
peut
être
compromise
p
 ison
de
l’absence
de
garantie
de
la
stérilité
au
moment
de
la
fabrication.
if
the
operator
loads
reagents
while
processing
module
status
is
scheduled
pause.
/
Le
fabricant
a
découvert
que
la
rotation
du
carrousel
d
ent
results,
folate
concentrations
for
normal
samples
are
lower
than
data
generated
for
the
package
insert.
/
Le
fabricant
a
reçu
un
nombr
he card. / La concentration en L-1-méthylhistidine contenue dans le supplément est supérieure à celle indiquée dans la notice.
vent
passage
of
a
guide
wire.
/
Ces
produits
sont
rappelés
car
le
dispositif
peut
s’affaisser
et
empêcher
le
passage
d’un
fil-guide.

ée)
montre
des
signes
de
prolifération
quand
il
ne
le
devrait
pas.
ifficult to activate the safety shield with normal technique. / Le fabricant a reçu des rapports indiquant que le mécanisme de sécurité peu
   results below acceptable range. / Le fabricant informe les clients que les résultats du contrôle de qualité ont mis en évidence des diminu

rtridges.
This
misidentification
could
result
in
inappropriate
treatments
with
heparin.
/
Un
petit
pourcentage
de
cartouches
Celite
ACT
on
ng
inaccurate
results.
/
La
valeur
paramétrique
de
la
numération
des
globules
blancs
figurant
sur
la
feuille
de
dosage
est
incorrecte.
Le
tau
ds
may
not
auto-clear
after
aspiration
of
sample
and
analyser>,
admin.>,
setup>
may
become
inoperative.
/
Le
fabricant
a
découvert
qu’e
numération des plaquettes par méthode optique utilisée pour traiter les échantillons des patients indique des valeurs extérieures à la plage d
the
patient
results
to
shift
such
that
treatment
may
not
be
initiated.
/
Le
fabricant
a
repéré
plusieurs
valeurs
incorrectes
dans
la
feuille
de
ntrols resulting in invalid runs with no patient impact. / Les valeurs des paramètres figurant dans le tableau de référence sont inversées; c
aînant la création du mauvais protocole.
er particles included in the test and could lead to false negative results. / Le fabricant a établi que ce produit présentait une baisse de sen
or
inaccuracy
and
quality
control
and
patient
results
may
shift
high
or
low
with
a
varied
magnitude
and
error
message.
/
Le
fabricant
a
dé
achment
can
break
and
lead
to
the
wheel
releasing
from
the
frame.

/
Le
support
avant
n’est
pas
assez
résistant
pour
supporter
les
forces

 s. The sterility of the product can not be guaranteed. / La présence de brèches dans la pellicule protégeant certains cathéters aortiques En
on
electrode
pads
or
paddles,
the
Heartstart
MRX
may
disarm
without
an
accompanying
inop
message.
/
L’appareil
Heartstart
MRX
peut
a
%,
not
3.0%.
error
may
result
in
reduction
in
staining
intensity
for
assessment
of
HER2
gene
over
expression./
Erreur
dans
la
formulation
d
 washing off. / On a identifié certains dispositifs Hovermatt dont les étiquettes se détachent ou partent au nettoyage.
 
release
of
the
throttle
handle.
/
Il
est
possible
que
le
ressort
de
l’accélérateur
se
brise
et
que,
par
conséquent,
le
scooter
ne
soit
pas
en
m
  abricant
a
reçu
des
plaintes
selon
lesquelles
les
artefacts
apparaissant
à
l’écran
risquaient
d’induire
une
erreur
de
diagnostic.
 ring
on
the
display
screen
of
the
device.
/
Le
fabricant
a
identifié
deux
cas
dans
lesquels
des
valeurs
erronées
pouvaient
apparaître
sur
l’é
  nce de l'activité de l'alanine aminotransferase (alt) au cours de la durée de vie des lots.
  nce de l'activité de l'alanine aminotransferase (alt) au cours de la durée de vie des lots.
astin HTF et Simplastin L. / Inscription de valeur erronée sur le carton du Verical Calibrator Set utilisé avec les réactifs Simplastin HTF et Sim
 ed
with
previous
lots
and
negative
bias
can
result
-20%
to-35%.
/
Le
fabricant
a
reçu
des
plaintes
concernant
l’obtention
de
résultats
moin
amps
together
actually
is
made
from
natural
rubber.
/
L’étiquette
du
produit
indique
«
sans
latex
»
alors
que
l’adhésif
de
la
bande
utilisée
 hich
may
result
in
injury
to
the
clinician
or
patient.
/
Le
Overhead
Counterpoise
System
II
peut
tomber
en
raison
de
la
défaillance
d’un
ann
 
complaint
received
regarding
this
issue.
/
Les
pointes
des
canules
ne
résistent
pas
au
test
de
la
résistance
mécanique.
Aucune
plainte
n’a


warmer
ambient
temperatures.
/
Lorsque
la
température
ambiante
est
plus
élevée,
l’entrepôt
des
échantillons
ne
conserve
pas
une
tempé
ccluded
and
not
obvious
to
the
user
and
a
potential
O2
pressure
switch
leak
of
failure.
/
Il
arrive
que
les
conduites
auxiliaires
internes
se
d
 ring specifications and the units may need to be recalibrated. / Il se peut que les doses délivrées par les dispositifs Sequoia soient inférieu
  
time.
It
may
happen
that
a
servo
I
running
on
one
batt
mod.
Indicating
30
min
OP.T.
could
run
out
of
power.
/
Le
Servo
I
alimenté
par
un
expose the patient to possible increased skin surface temperature and reddening of the skin. / Il arrive que le conducteur de lumière Spot
 were in the low range of the assigned values and sometimes out of the low limit. / Le fabricant a reçu des plaintes selon lesquelles les rés
  gent
and/or
shortened
clotting
times
with
reagent
stored
at
2-8
degrees
celsius
after
reconstitution.
/
Le
fabricant
a
reçu
des
plaintes
con
  rheated
and
deformed
the
disposable
syringe
used
with
the
injector.
/
Risque
de
brûlure
pour
l’opérateur
s’il
entre
en
contact
avec
un
di
  ontrol values. / Le point de consigne pour le facteur rhumatoïde a changé et pourrait augmenter les valeurs pour les patients et le contrô
 nt
a
reçu
des
rapports
indiquant
l’apparition
des
codes
d’erreur
919
et
920.
Dans
ces
cas,
la
pompe
ne
se
mettait
pas
sous
tension.

ec
les
bobines
crânes.
e
marque
Vail
vendus
ont
été
modifiés
et
réétiquetés.
 s
of
important
data
that
is
necessary
for
patient
treatment.
/
Si
le
programme
se
ferme
pendant
une
sauvegarde
«
Enregistrer
tout
»,
des
 r
no
carbamazepine
are
high
and
results
from
samples
with
true
carbamezapine
are
low.
/
Le
fabricant
a
confirmé
qu’il
était
possible
d’ob
tudies
have
identified
circumstances
in
which
negatively
biased
results
can
be
observed
for
less
than
seven
days.
/
Il
est
mentionné
dans
l
d by wells that produced a lower than expected light signal. / Le fabricant a reçu des rapports indiquant la présence de biais positifs dans le
  d
the
other
labelled
as
1624WB
and
should
be
1626WB.
/
Certains
numéros
de
lots
ont
été
mal
étiquetés;
l’un
porte
la
mention
1626WB
 sinfectant
using
ml
scale
on
bottle,
remove
TMP
advise
portion,
clarification
of
bicarbonate
display.
/
Le
manuel
a
été
modifié
ou
des
adde
  ugh to deal with any biofilms that may have built up in units. / Vapotherm est arrivée à la conclusion que sa procédure de nettoyage pouv
nctions
of
the
flipped
bit
were
a
complete
shutdown
of
the
metre
or
a
too-low
and
non-plausible
result.
/
Corruption
possible
de
la
mémo
  t
in
an
overdose.
/
La
documentation
destinée
à
l’utilisateur
n’est
pas
claire
quant
à
la
valeur
de
la
dose
totale
associée
à
l’ensemble
des

 icielle pourrait donner lieu à une surdose touchant les organes non vitaux.
ower
law
or
modified
Batho
heterogeneity
correction
methods
can
be
wrong
if
the
beam
data
contains
XXX.LIH
file.
/
Les
calculs
de
la
dos
  hantillon
du
lot
concerné
s’est
révélé
non
conforme
aux
valeurs
minimales
de
résistance
à
la
traction.

outside
the
confidence
interval.
/
Le
fabricant
a
reçu
des
plaintes
concernant
le
taux
élevé
de
rétablissement
aux
valeurs
de
consigne
du
sy
  emballage
n’est
pas
complètement
scellé;
la
stérilité
du
produit
pourrait
être
compromise.
 iglide
Femoral
Drill
in
the
Uniglide
Femoral
alignment
guide
during
use.
/
Des
enquêtes
préliminaires
ont
mis
en
évidence
des
problèmes
d
 ite.
/
Des
problèmes
de
fonctionnement
entraînent
un
faible
débit
lumineux
pouvant
nuire
à
un
bon
éclairage
de
la
zone
d’intervention
ch
 e,
run
intermittently
or
revert
to
a
default
setting.
/
Il
existe
une
possibilité
qu’une
carte
de
circuits
imprimés
défectueuse
dans
l’interrup
 ons
for
use.
/
Le
fabricant
a
fait
parvenir
à
tous
ses
clients
une
lettre
dans
laquelle
il
souligne
l’importance
de
bien
suivre
le
mode
d’emplo
e
wrong
identifier.
/
Les
deux
plaques
ont
été
interverties
durant
la
fabrication
et
un
mauvais
code
d’identification
peut
figurer
sur
leur
ét
fficient
for
quality
assurance.
Depending
on
samples
for
mean
and
expected
ranges,
control
limits
may
be
too
wide.
/
La
procédure
«
perf
ushes
and
the
commutator
within
the
ventilator
motor/ball
screw
assembly.
/
Le
ventilateur
de
certains
systèmes
d’anesthésie
Fabius
GS
m
<1pg/ml
specified
in
the
directional
insert
to
<5pg/ml.
/
Les
résultats
d’épreuves
maison
indiquent
que
la
sensibilité
analytique,
qui
devr
 allowed
helium
to
vent.
/
Un
tube
flexible
en
téflon
servant
à
évacuer
l’hélium
dans
le
système
Signa
MR
s’est
fissuré
en
raison
de
la
fatig
intended
use.
There
is
the
potential
for
needle
stick
while
using
the
lancing
device.
/
Deux
lots
d’autopiqueurs
OneTouch
SureSoft
(SW
27
ting
in
level
sense
error
messages.
/
Les
cartes
électroniques
du
Synchron
CX5
PRO
qui
permettent
la
mesure
des
concentrations
sont
mu

 hen
used
for
less
than
28
days,
the
bias
is
a
function
of
length
of
time
on
analyzer,
number
of
tests
remaining.
/
Le
fabricant
a
reconnu
ce
 ditional dilution. / Le fabricant a reçu des plaintes au sujet de résultats biaisés négativement lorsque le système procède à une dilution su
5. / Le feuillet qui accompagne le produit ne contient pas les plages témoins acceptables mis à jour le 24 juin 2005.
eference
point
the
treatment
field
can
change
without
warning
which
could
result
in
an
overdose.
/
Si
la
modification
d’un
plan
de
traitem
  er
latex
may
be
mislabeled
indicating
latex
free.
/
Le
fabricant
informe
tous
les
clients
que
l’étiquette
des
rouleaux
de
bandage
élastique

et
claims
in
the
directional
insert
concerning
correlation
with
the
IRMA
ACTH
assay
catalogue
#
40-2194.
/
Des
tests
internes
ont
révélé
qu
 of
telescope's
main
body.
May
cause
connection
between
telescopes
and
hysteroscope
sheaths
to
become
loose
during
use.
/
Sur
certain
de l'activité de l'Alanine Aminotranferase, au cours de la durée de vie des lots.
 lts
including
comma
will
cause
system
to
trucate
numbers
following
comma.
/
Dans
l’application
qui
permet
l’analyse
des
résultats
d’une

 . / Les fichiers de données archivées peuvent, dans certaines circonstances, être corrompus à la réouverture.
ther
wedge
parameters.
No
warning
given.
/
Lorsqu’on
tente
d’importer
des
coins
virtuels
à
l’aide
de
RTPX,
l’angle
de
ces
coins
apparaît
d
 alue=1/2
plan
symmetric
value,
then
X2/Y2
jaw
value
out
of
position.
Treatment
will
not
be
inhibited.
/
Si
le
mode
du
champ
symétrique

 
workflow.
/
Un
verrouillage
du
système
et
une
perte
d’images
peuvent
survenir
lorsqu’on
répète
l’inscription
de
patients
selon
un
dérou
ms used with Bact/Alert PF bottles. / Identification d'une anomalie au niveau du logiciel de tous les systèmes Bact/Alert 3D, 3D COMBI et 3
ts was observed. / On a observé une augmentation constante du taux de débris internes (mode de défaillance : maillons de stent brisés) d
 
at
the
time
of
injection,
could
cause
serious
events
such
as
hemorrhage
from
vital
organs
such
as
aorta.
/
Le
fabricant
a
reçu
un
certain
n
esult
in
misinterpretation
of
results.
/
Avis
public
-
Un
changement
d’unité
de
mesure
de
mg/dL
à
mmol/L
introduit
par
l’utilisateur
peut
e
 h
implant
time
with
no
failures
beyond
22
months
of
implant.
Second
mode
a
no
output
condition
was
exhibited
at
the
implant
procedur
  ires
to
the
electronic
board.
This
connection
can
break
and
has
to
be
replaced
with
flexible
wires.
/
Le
potentiomètre
derrière
la
manette
 nd
could
cause
an
overestimation
of
patient's
IGE,
Ferritin
and
STFR
values
from
15-25%.
/
Le
fabricant
a
décelé,
dans
ces
lots,
une
diverg
ting
of
sample
results.
Problem
is
correctable.
/
La
fonction
«
number
of
specimens
»
(nombre
d’échantillons)
du
logiciel
SmartCycler
DX
c
  15
ATMS
but
will
be
adding
further
additions
to
the
warnings
to
highlight
this
maximum
15
ATMS.
/
Le
fabricant
attire
de
nouveau
l’attent
  ft
in
recovery
for
results
which
may
be
magnified
by
vol
of
24
hr
sample.
/
Le
logiciel
effectuait
un
ajustement
dans
les
calculs
de
la
base
d
 ing
of
the
DC
adaptor
&
batteries
that
can
heat
up
&
cause
the
plastic
compartment
to
melt
or
battery
leakage.
/
Les
utilisateurs
peuvent
 fabricant a décelé un léger défaut de performance se traduisant par un allongement du TCA (temps de céphaline activé).
 agments
of
PTFE
plastic
lining
of
the
sheath.
/
L’extrémité
pointue
d’une
vis
rattachant
l’occludeur
au
fil
de
livraison
pourrait
gratter
la
couc
  recovery for those parameters. / Le sérum témoin CD-Chex plus, CD4 faible, de la société Streck nécessitait une révision des valeurs témo
w-lot
verification,
shift
in
low
quality
control
results
and
lower
recovery
on
patient
results
of
-3
to
-15%.
/
Le
fabricant
a
confirmé
qu’une
e
  ram
quality.
Controls
from
80
CDN
kit
recalled
&
replaced.
/
Les
sérums
témoins
de
niveau
1
et
2
(lot
31205)
de
la
glycohémoglobine
A1c
  FITC/B4-RD1
6605015,
CS
B4-FITC

PN
6603859
or
CS
B4-RD1
PN
6603846
when
analysed
as
per
instructions.
/
Les
dispositifs
de
diagnost
 ns between lots FS2089 or FS9914 and lot FS3050, more specifically, with slightly positive results. / Études récentes rapportaient des diffé
 es./ Décroissance des valeurs du D-Dimere au cours de la durée de vie des lots seulement pour certaines méthodes ou appareils.
 reagents. / Inscription de valeur erronée sur le carton du Verical Calibrator Set utilisé avec les réactifs Simplastin HTF et Simplastin L.
etween
the
8F
sheath
tip
and
7F
dilator
body
creates
a
gap
that
may
lead
to
insertion
difficulty.
/
Des
introducteurs
de
7F
ont
été
conditio
nsion
on
the
drawing
for
the
implant.
/
La
première
broche
de
l’implant,
un
hexagone
de
1
point,
était
peu
profonde
comparativement
à
la
 centage
of
product.
/
Le
fabricant
a
reçu
des
rapports
faisant
état
d’ailettes
ou
de
poignées
fissurées
ainsi
que
de
difficultés
rencontrées
a
 nd
for
out
of
range
quality
control
results
for
QC
A.
baumannii
ATCC
49139
vs
Fd.
Lowered
MIC
results
may
be
obtained
on
this
panel
resu
 insert
(insert
code
311-11)
instead
of
the
package
insert
for
referencells
(insert
code
300-11).
/
Erreur
de
conditionnement
–
certaines
tro
 
La
fonction
du
navigateur
d’image
peut
ne
pas
afficher
correctement
les
lignes
de
référence
sur
les
topogrammes
en
TDM.
oper
peeling
of
the
sheath
during
use
in
a
small
percentage
of
products.
/
L’entreprise
a
été
informée
qu’un
faible
pourcentage
des
gaines
nnot be ensured with these affected lots. / Il est possible que dans certains lots, le bras latéral soit incorrectement attaché à la poignée. O
or
improper
peeling
of
the
sheath
during
use
in
a
small
percentage
of
products.
/
L’entreprise
a
été
informée
qu’un
faible
pourcentage
de
as
required
by
the
US
21
CFR
part
1020.31
(g).
/
L’examen
a
mis
en
lumière
trois
situations
où
l’appareil
de
radiographie
ne
fonctionnait
pa
 de labels that may cause false negative results. / Anomalie du logiciel lors de l'identification des bouteilles bact/alert BPA et BPN avec les é
ort
for
the
base
has
not
been
achieved
by
the
host
bone
and/or
bone
cement.
/
La
prothèse
peut
se
rompre
à
la
jonction
de
la
base
et
du

 ng
on
the
electro-surgical
generator.
/
Il
est
possible
que
le
mode
de
défaillance
entraîne
une
incapacité
permanente
ou
transitoire
de
mo
 and
an
angle-corrected
pulse-wave
doppler
waveform.
/
Une
erreur
se
produit
après
le
radiomarquage
sur
forme
d’onde
fixe,
réalisé
à
l’ai
 novembre
2006
est
inexacte;
il
s’agit
plutôt
du
11
janvier
2006.

on
in
a
percentage
of
the
valve
assembles
of
the
affected
lots
that
prevents
complete
shut
off
of
the
valve.
/
Le
régulateur
d’aspiration
com
ation
and
correlation
has
drifted
from
the
reference
method.
/
Le
réactif
et
le
calibrateur
du
facteur
rhumatoïde
CX
se
sont
éloignés
de
la

reil
peut
indiquer
un
temps
de
prothrombine
(TP)
peu
élevé
chez
les
patients
traités
par
anticoagulothérapie.
was
found
after
initial
company
recall
done
on
April
2002.
/
L’extrémité
distale
de
l’obturateur
du
lot
no
10123
s’est
séparée
de
la
tige
pro
 et/CT
System.

This
issue
may
lead
to
the
misinterpretation
of
anatomy
at
the
center
of
the
image.
/
Une
anomalie
a
été
découverte
dans
ted
incompatible
result.
/
L’épreuve
de
compatibilité
croisée
par
centrifugation
immédiate
(IS_XM)
réalisée
à
l’aide
du
système
Galileo
pe
a
warm
room,
for
prolonged
periods
in
standby
mode.
At
44
c.
Alarm
will
trigger
and
system
latches.
/

Le
réfrigérant
des
unités
Coolgard

arker
of
infection
in
neonates.
/
L’essai
turbidimétrique
Synchron
pour
le
dosage
de
la
protéine
C-réactive
peut
ne
pas
être
suffisamment

  rect dose distribution and monitor units. / Les résultats seront effacés si l‟application Éclipse n‟est pas utilisée au cours des modifications, ce
  réactif est périmé et, ne pouvant étalonner correctement, il ne fournira aucun résultat.
  ed results during calibration period. / Les électrodes de potassium pourraient ne pas atteindre leur limite de durée de vie de 6 mois et (ou) fo
traîner des erreurs.
Les fioles de Retic-C Cell Control Level II pourraient avoir été mal étiquetées. L‟étiquette erronée correspondrait à celle des fioles de 5 C cell
   enquête a démontré que le modèle n‟est pas en mesure de fonctionner avec la charge prévue.
                                                                                       ̊
 the l-cath 16 gauge product) potentially leading to patient risk. / Des plaintes ont été reçues de la part de cliniciens qui ont été incapables de
 bel. It was omitted from all languages present. / L‟instruction « autoclave à 121 C pendant 15 minutes » a été omise dans la section des ins
ackflow of patient's blood into the set. / L‟assemblage inversé des raccords d‟entrée et de sortie sur la cassette du dispositif d‟administration
  ouch, which serves as an oxygen barrier during gamma irradiation and may affect long-term performance. / Une inspection interne a révélé
 's built in report. There is no accuracy issues when the system is configured otherwise. / En raison d‟un défaut du logiciel C.0.0., des résultat
e some of these trays were shipped to customers. / Des plateaux qui contiennent de la lidocaïne et qui posent des problèmes sur le plan des
ng base following a mains power interruption and may compromise patient safety. / Le fabricant a reçu des rapports indiquant un risque pote
 potential for therapeutic consequences in the control of anticoagulant therapy. / Modification de la priorité des rappels précédents concernan
e and should not be relied upon to gauge acoustic exposure. / L‟affichage acoustique de l‟IM (indice mécanique) et de l‟IT (indice thermique)
  ent platforms is not correct and could result in inaccurate test results. / Problème d‟étiquetage : L‟étiquette ISI pour Simplastin HTF sur le sy
ackage inserts. / Le fabricant doit fournir davantage de renseignements sur la désignation des valeurs témoins actuellement absente de la no
  ssuing instructions to conduct maintenance to ensure the screws do not become loose. / Le fabricant a reçu des rapports indiquant la chute
be started until the alarm is resolved. / L‟avertissement de vérification de la collerette pourrait se déclencher bien que la seringue soit correct
 the internal circuit board to become thermally charged. / Les lits équipés d‟une boîte de contrôle Linak susceptibles d‟être défectueux, pourra
 lt. This may allow the head section to shift or drop to one side. / Il y a une possibilité que le boulon d'articulation de la surface du lit puisse se
 . The leakage condition is associated with an undersized luer taper in the spinal needle hub. / Becton-Dickinson a reçu des rapports signala
  is higher than the expected range of 2-4%. / Certaines fioles des cellules a1 et b de ces lots ont une valeur d‟hématocrite se situant entre
     4
265) and previous lots of reagents. / Biais négatif d‟environ 15 % entre le plus récent lot de réactifs du cortisol Access (lot 421265) et les pré
ontains the date and time of the control run and other errors occur. / Lorsqu‟on imprime le rapport sommaire sur deux ou plusieurs pages, la
  on under certain conditions. / Lorsque le dispositif est utilisé avec la pompe Colleague, il est possible que, dans certaines conditions, une oc
  alse negative results. / Le fabricant a reçu des rapports signalant une réactivité réduite dans certaines fioles et il existe un risque de faux rés
urnit la charge électrique adéquate, mais inscrit le mauvais chiffre sur le programmateur.
  of leakage associated with the plastic hub of the needle. / BD a informé Cardinal Health qu‟elle rappelait les canules à ponction lombaire BD
 generated by obi, causing loss of original planned rotations. / Le OBI peut permettre par mégarde la réécriture des rotations planifiées du lit
 to change the unit of measure from mmol/l to mg/dl and misinterpret results. / Les lecteurs garantis OneTouch Ultra des lots nos t0407280x
 re within 2-8 deg c at warmer ambient temperatures. / Beckman Coulter a confirmé que le parc d‟entreposage des échantillons ne conserve
 ansducer could be dislodged and lead to failure of the unit and a remote possibility of electrical shock. / Le joint de colle entre la base du boî
 mbole de réglage d‟intensité sur l‟étiquette principale de l‟appareil.
within a short time from the same voxelq the resulting stored dataset may become mixed. / Anomalie du logiciel : si la commande « trouver »
 aligned with the initial pet data when it is displayed in the multiseries viewer. / Suite à une scanographie ou une TEP complète du corps et au
  rde, l‟utilisateur final pourrait modifier l‟unité de mesure et mal interpréter les résultats de l‟appareil.
panier n‟est peut être pas placée correctement.
d to an mr scanner as a result of the customer not completely engaging the pump into the bracket. / Le fabricant a reçu le rapport d‟un patien
  eft cuspid being incorrectly configured with a -7 degree torque rather than a +7 degree torque. / Une erreur est survenue au cours de la prod
 11004680) the blind end can separate from the tube during an application. / Au cours de l‟utilisation du tube souple pour implantation, l‟operc
els to separate, which will cause a bulge in the blanket that could possibly shift a small patient's position. / Le matelas ne relâche pas assez d
 n incorrect label. / Conditionnement erroné possible. La gravure au laser sur le dispositif reflète la taille correcte mais l‟étiquette n‟est pas la
 , may be difficult to cut and suture, prone to fraying, handling characteristics and inadequate tensile strength. / D‟après le fabricant, certains
ork itself loose due to vibration. Potential malfunction or unexpected ventilator shutdown may result. / Une vis dans le dispositif d‟alimentation
  filetés ne bloquent pas correctement dans les coquilles.
   pulled for the kit had the wrong slot size. Hook .018 slot was used rather than hook .022 slot. / Au cours de l‟assemblage de la trousse du p
dersized luer taper in the spinal needle hub. / Le fabricant a reçu un rapport concernant une fuite au collet en plastique due à un collet effilé L
 te seal that may cause a compromise in the sterility of the product. / Une des poches de reniflard en Tyvek livrée à Medline par Alcan packa
 bricant a reçu des rapports concernant une fuite au niveau du collet en plastique de l‟aiguille.
 on-Dickinson medical 25 gauge spinal needles. There were reports of leakage associated with the plastic hub of the needle hub. / Le fabrica
 os de lot de l‟instrument sont étiquetés avec une date de péremption inexacte.
 n sous tension de l‟Axiom Artis dans la salle d‟examen peut cesser de fonctionner de façon sporadique.
 tion.
/
Si
on
n’appuie
pas
parfaitement
au
centre
des
boutons
de
fluoroscopie
dans
la
poignée
d’alimentation,
ceux-ci
peuvent
rester
coin
 rences in balloon detachment strength and can result in complications such as inability and premature detachment, can cause severe disab
 ntial for excessive wear to occur on the drive belts used for the image intensifier and/or x-ray head drive. / Le but de cette modification est de
 e) range of 0.6 - 19.0 mg/dl. These samples may be negatively biassed and give values within the reportable range without an initial dilution.
 een removed from this recall.


 ead to further investigation, and that the possibility of misinterpretation and incorrect patient management are low.
d levels of IGF-1.


 U values for calibrators, controls & patient samples giving unexpected positive or negative results or incorrect dose.


 ecision to update the affected value assignment sheets to ensure the performance of their products.



agnosed for thrombosis and embolism.




 ode 08_05, was defective and is associated with this issue. We are recalling IABP's manufactured with the display controller assembly date


ose display.


 cularly those with cystic fibrosis or granulomataous disease. The manufacturer has received reports from dental practitioners of adverse eve


%. Abbott has made the decision to remove these cartridge lots from the marketplace to ensure the performance of the product.
as non-coring needle.
esion performance would be decreased, and this would have a negative effect on the durability of the filling.
s 25 and is the accurate limit for the flexible probe with a blocking washer, gm11002420, usage.
 nd/or Immulite 2500. Siemens Healthcare Diagnostics has confirmed that the substrate lots may have impacted 31 Immulite 2000 and Immu


ating primary posterior stabilized housing collet. Excess material does not allow the collet to slide into position and sit flush against the resect


ce could compromise its performance over time and affect the AED's ability to make a therapy decision during use.
 nlicenced device). However, there is an equivalent product utilizing a different reference that is properly registered with Health Canada. Ther


crotube due to an error that occurred during pipetting. When this occurred, the analyzer did not generate a card volume error as expected, w
me. This problem only impacts Ortho Provue Analyzers that had software version 2.15 or 2.16 loaded prior to having software version 3.1 ins




system cannot be restarted. As this is an intermittent failure no work around is available and no actions can be done by the user to prevent th
h assembly. This only affects units with date codes (mmyy) of 0908, 1008, 1108, 1208 (units manufactured between September 1, 2008 and
ash station which may diminish cellular fluorescence staining and presenting a risk of erroneously low results.
 kwards. Affected devices may intermittently report C02 and C12 error codes, which result in the device being unavailable for use.


g the system probe or bead mixer to hit the cap.
g the system probe or bead mixer to hit the cap.


e table up to the end switch. Unexpected movement can cause injury.
ave also been noted with the Access Cortisol Reagent Pack lot identified.
APO CAL) lots M901536 and M904505.
 risk of electric shock may result.
ge the centre column of the table by accessories impinging the column and causing separation along the mating seam of the sheet metal sh


 sample tube may be pipetted.




ion is 0.5ma according to IEC60601-1:2005.
e vial barcode for chem 2 cal level B lot 9GM001. An investigation of the barcode indicates that there are two additional digits in the barcode
DRB1*0401 homozygotes, since they could be erroneously reported as DRB1*0426.


 s no opportunity to correct or modify the check valve assembly.
of the applicator body in combination with field sizes of 5cm x 5cm or smaller and energies of below 6mev.
 e measured results can be incorrect with no indication to the user they are wrong.
area resulting in no treatment or treating a non target area.




offline workstation, and measure the zoomed clip. Measured results may be incorrect with no indication to the user they are wrong.
ed assays on the echo.


) values has been observed when Architect HAVAB-IGM and Architect Anti-HBS (LN 7C18) assays are run together on the same architect m
 sitive sample.
ue positive signal could mean that a test would have to be repeated.


n these cases the patient's diagnostic CT must be increased in width to accommodate the Hi-Art radiotherapy couch width. With 4.0 and 4.0
gical lighting and media systems.
mum of 250 pounds. If breakage occurs the user could fall and suffer injury including broken bones and bruising. 75 incidents with 6 resulting
aximum of 250 pounds. If breakage occurs the user could fall and suffer injury including broken bones and bruising. 145 incidents with no inj



onoblock Mom Cups with corresponding head sizes less than 50mm in diameter. The notice reminds customers to strictly follow the implanta
 vice for dialysis needles or pressure dressings used after dialysis treatments. Only the identified lots were imported by 3M Canada.




 to overestimate of size of breast lesion.



Omnifit Eon Surgical Protocols, as well as to provide specific instructions for rasping dense bone and/or narrow intra medullary canals for the
. B) If the first patient's last image had measurement results they will appear on the next patient's image. C) When a distance ratio or area ra



The isolated cells were placed into cell culture for further testing and contamination was evident after 14 days of culture. The laboratory confir
 steering around corners may become more difficult.




 e lot number on the individual piece.
ngth. It has been suggested that the metal used to manufacture parts from lot 55QJ may have a similar problem, though testing has not show


 al implant position after a period of six to fifteen months post operatively.
lts from previous lots.
can compromise the product sterility.



nd process control requirements.
ng the accessory to the operating room table interface, is too large.
e handpiece to self activate.




 ulin M analytes.


ncorrect sample ID‟s may be electronically written to the radio frequency ID tags on the sample carriers.




e force becomes too high the manifold cannot be rotated - therefore it cannot be inserted or removed. Once this occurs there will be no vacu
58DB lot number while the inner pouches are correctly labelled as lot 96159DB.


 ew wavelength as requested.


ur, the MPR may loose its ability to generate the positive pressure necessary to function properly.
 been shown to remain intact. Proper dispensing technique must be followed, placing the product, rather than the inner pouch, into the sterile
04/26 to 2007/08/01.



 an expose patients to potential adverse events including a delay in procedure time due to catheter exchange, vessel trauma and stroke. Bos




and/or end-user.




nly cool wipes. This might lead to irritation of cornea and in rare cases to reversible corneal erosions.




d in 2007 and all internal product was corrected, however the product in the field was not corrected.


 ents the current operating instructions and technical manual held by Canadian customers which already cautions against using solutions con
marketplace.
urs when the monitor's analog output is set to external.
al 6mm Aimer is marked as 4mm.
another type of cells.
as retained in a patient.
power-fail alarm. The test procedure has been revised to check that the power-fail alarm operates for at least 12 minutes. The revised test pr


re was a requirement to install the revision 'I' software upgrade before reports were printed to ensure data was reported (printed) correctly.
ts on samples that are Aa*0301 homozygote, since they could be erroneously reported as A*0301/A*1101.


should have been etched '2357-09-06'.
dation and the potential for a compromise in the sterility of the product.
he ASP AER and to remind users to observe the illuminated temperature light during the cycle. ASP has received user reports about imprope
SPO2 data condition.


ew due to the surgeon being unable to remove the screw. There had also been reports of damage to the screw and/or the plate while attemp
ch would result in a warning message and the instrument would shut down.



 licone portion of the Titan Anchor, model 3550-39. If this occurs it may result in lead migration and compromised therapy for the patient.




al implant position after a period of six to fifteen months post operatively.


on has determined that the product is not manufactured to specification. The pilot broach for threading the internal threads of the implant is to


d status exam.
Error 103 (karel e-stop detected) and error 342 (Deviation in absolute position value DSE - RDC) were displayed. Recalls 50114 and 5025



es. There is no risk to patients who receive these implants prior to January 2010, when devices from the affected lots begin to expire.
 e same lot number and expiration date. The box contains a reagent bottle and dye pouch, both of which were correctly labelled, and the con
 probable cause is using a surgical technique which differs from that prescribed in the surgical technique for the Durom Acetabular Cup. This




ss fractures or broken. The pole mount clamp has been redesigned by the manufacturer and customers of record are being advised to inspe
pping sample processing, the system will post a yellow 'caution' event and continue to operate with the dispense plate in an elevated position


hift coordinates will be based on ISOcenter position. This will lead to an incorrect table shift.
ausing the display to go blank. Audio alarms will continue to function normally.
aline or water, to enter the table column.
odels 3010a and 3500 ("pump"). These are high priority alarm messages which can occur for a variety of reasons as part of the usual self-te




stem date for all SDC HD units would re-start from October 1st 2001 and begin incrementing from that point onwards. This event would not a


corrosion. The affected units should be monitored and replaced if necessary.
s could cause a possibility of malpositioning of the cup due to use of the device in a mechanically seized condition.




ains is missing a label.


 ty during cement preparation, as well as when waiting to deliver the bone cement with the delivery device (e.g. bone filler device).


 that conical collimator. With wrong field size, unintended radiation is given to patient outside the outer edge of cone.
proved plans' selected in treatment administration. Therapists can acquire gantry angle into plan, even without system rights to acquire gant
ubbles not be detected.
605, 152737, 155488 and 157297 of elecsys thyroglobulin calibrator. The manufacturer has determined that customers should not use it for




 ling to the floor.
 n range of 6.8 to 7.5 resulting in a lab investigation. The investigation revealed that some units from different lots post ETO sterilization have
tion can lead to additional manipulation to separate the haptics from the optic during surgery which could lead to an injury.


 ogue # 90022.
th RF generators and EP equipment, including the Carto 3 system. If RF energy and pacing stimuli are delivered simultaneously, across the


EDTA whole blood or plasma sample only". The kit is intended for use with urine samples not blood or plasma.
ble (equivocal).


 ra during specimen collection of male patients.


 he panel type POS combo 33 (PC33), an issue has been confirmed for QC isolates when tested on the walkaway instrument. This issue onl
with non-Siemens APTT reagents.
nts the current operating instructions and technical manual held by Canadian customers which already cautions against using solutions conta
Error 103 (karel e-stop detected) and error 342 (deviation in absolute position value DSE - RDC) were displayed.




ys may be impacted.


orrectly identified as reactive for total antibodies to the core antigen of Hepatitis B virus.




will meet the expiration date on the label.

alues for one of seven ranges stated in the directions for use. Product is a control sample used by laboratory for internal quality assurance. A new range is




in diluent leakage during initialization of the analyzer, resulting in "diluent empty" faults.
 he potential to lead to a variety of catheter functional failures and clinical consequences as described in the instructions for use. Patients wh



interfere with the intended conformal fields of the BrainLAB M3 during patient treatment. This may cause a critical under-dosage of the targe
to become detached from the mount and fall.


glass reagent vial while attempting to unscrew the cap prior to use.
 ents within the small black cylindrical head, called a transducer. Reduced ultrasound output may affect the progress of patient fracture healin
p and coupler of the Fowler clutch assembly.


 not sufficiently tightened.
ber of events relating to what has been generally described as clip detachments.




 tween the coverglass of the light guide cable and the ledge does not meet specifications. Production between January 2009 and May 28, 20
                            -
all for CAL B/CAL A" and /or
1005 "result cannot be calculated, final RLU read is outside the specification of the lowest calibrator".
onent size selection. The engraved numbers on the impactor cap do not agree with this information and are erroneous. As such, the number
 al Shell (LSP69) in order to clarify and highlight the differences in reaming technique.
urgically removable if the Cochlear Implant patient needs to undergo an MRI. AB reports that devices manufactured between May 27 and Ju




hen using pulsatility index tool which is sensitive to noise in spectral Doppler waveform causing mis-trace, user is unaware of miscalculations

 defect in SW version 103.0 and 104.0 of the Stellant CT injection systems may cause ISI 700 accessory to incorrectly trigger bolus tracking on a Philips C
 STM standards for titanium surgical implants. As such, areas of modified material properties may result, which may affect the intended use
plied. As a precaution and due to the potential impact on the mechanical properties of the affected products, Stryker is recalling all products
he surrounding atmosphere. If the vent does not work properly, this could result in too much or too little insulin being delivered. / Environ 2 %




met for lot numbers: M802452, M804502, M807345 and M808329. Calibration failures occur at 12 months.



ed in the module. This may result in a leak at the connection, delaying treatment.
 indicator (ERI) at 54 months post-implant. For affected pumps, the minimum time frame of 90 days between ERI and end of service (EOS)
P systems.
 and can result in an erroneous protein C chromogenic activity result.
t 2-8 c as recommended.




 head ring mounted on a floor stand or pedestal.
EDTA whole blood or plasma sample only". The kit is intended for use with urine samples not blood or plasma.
ted. The specimen was known to have a bilirubin concentration higher than the linear limit.


ally size 3. For lot KNTK, there are devices in unit boxes with labels marked size 3 and devices marked '514.0300, size 3', that are actually s


damage to a body structure.



pancy caused the CyberKnife Treatment Delivery System to post Error 103 (karel e-stop detected). Also, the robot controller detected the inc
 wire harness is pinched such that the conductive wires are exposed, they can short to the electrically conductive coating on the inside of the
ng is to be removed followed by a visual inspection prior to packaging. The problem may cause partial or complete blockage of a vessel due
eported with an incorrect result value resulting in inaccuracy, imprecision, or error comment reports together with the result.
orrectly identified as reactive for total antibodies to the core antigen of Hepatitis B virus.
the validity criteria set by the macro component of the LightCycler 2.0 instrument.


 be delayed or


STM standards for titanium surgical implants. As such, areas of modified material properties may result, which may affect the intended use
ps to indicate pulses when monitoring SP02 (oximetry).


ion. 4) Certain fluids solidify in the pumping mechanism. 5) IUI connector failure when they become corroded or contaminated.




Error 103 (karel e-stop detected) and error 342 (Deviation in absolute position value DSE - RDC) were displayed.
y the console. When this happens the stylus or EHS HP is inoperative.



al bridging between heater pins.


g or body during shipment to the end user resulting in the potential for the accidental aspiration of the tether into the patient's lungs.
n increased rate. Without routine operational checks, wear of the connection could ultimately prevent the device from sensing that the pads t




ndangering the patient or operator.




condition that prevents the lead from delivering therapy to the vagus nerve.
o all Intera 1.5T and Gyroscan Intera ACS 1.5T MR systems with a Synergy Flex M/Shoulder Coil 1.5T initially delivered as release 5.1.7, 6,



s a product 4027.
-back to MDB.
ne/ventilator and the patient monitor through the N-DISVENT-02 interface, there is the possibility of incorrect patient weight and/or height rec
condition that prevents the lead from delivering therapy to the vagus nerve.


ystem did not mark the treatment as interrupted. When the treatment was re-run, the entire treatment was delivered instead of starting at the


tasks to "done". In this rare instance it will continue to appear on the flowsheet and the pending orders list.
so that the indicator paper will not change colour.




d to serious injury or death of the patient.




e potential for a suction catheter to become lodged in a tracheal tube which may require extubation.
also causes a weekly self diagnostic test to run hourly depleting batteries faster than normal when stored without an external power source.




t in quality control results and patient results for IgG, IgA, TRF and IgM.
stablished gas chromatography flame ionization detection (GC-FID) method traceable to certified phenobarbital standards.



ity control and patient results.
he operator, an erroneous result could also be generated by the Vitros 3600 Immunodiagnostic System.




 condyle in the posterior chamfer region. Microscopic cracks have the potential to affect the performance of the implant.


te can work loose and the clip can become separated from the hand control. If both screws back out completely, the internal components of




of the implant from the package while maintaining sterility.
ad to a radiation exposure rate in excess of the 11.5 R/min Health Canada requirement. However, it will only occur if the grid switch fails duri


1, 7.0.2, 7.1 & 7.1.1



an create a second instance of the same order marked as pending, if the following conditions occur:1. An order or intervention is entered as
xel or header data.



er box information is correct as well as the barcode information on the plate frames and microplate strips.
nt to incorrect volume could result, potentially leading to serious injury.


e and 3 cm/min paper speed. This behaviour would have the most impact in Europe and Asia/Pacific where other settings are preferred. If th
ht/left annotations will be reversed on views that were created with a short curve.
onals and vice versa.
ay not be accurate.
arte de circuits imprimés de logique fluidique (numéro de pièce 450116-002) comporte un défaut de conception technique (cavalier manqua




oodstream.
ndique qu‟elle est de 10 mm x 160 mm.




 nnement de la gate du système de gate Kwiktrak, lors de ce mauvais fonctionnement, la barrure de la gate peut rester ouverte même si les
 ted. / Lorsqu‟on recourt à l‟outil conçu pour les tests d‟hématologie qui permettent de poser un diagnostic différentiel de la maladie artérielle
 des valeurs cibles et de consigne du calibrateur D-dimère ainsi que du témoin lorsque le calibrateur est utilisé avec le prochain lot du réactif
 ins défibrillateurs automatisés externes (DAE) Lifepak CR Plus comportent un câble flexible interne susceptible d‟être défaillant. Ce câble po
sseur de vibrations de l‟analyseur Cobas Amplicor a été utilisée comme pièce de remplacement d‟un analyseur Cobas AmpliPrep au lieu de



 un retrait du dispositif en raison d‟une erreur administrative.
angement de procédé peut faire glisser le cône supérieur par-dessus le ballonnet puis tomber du tube. Il y a eu une augmentation du nombre


 sur les écrans repeints ne respecte pas les normes d‟adhérence de la peinture. Par conséquent, on a observé que la peinture sur les écrans
 t. / La carte d‟étalonnage peropératoire indique un mauvais numéro de lot sur le code à barres (il s‟agit du même numéro que celui de l‟étalo


. / On a signalé des cas où les barres de suspension s‟étaient disloquées involontairement en entrant en contact avec des surfaces de glisse


vercles de compartiment à pile des pompes à insuline Animas 2020 et Animas IR 1200 ne gardent pas le contact avec le compartiment, ce q
n sur l‟écran et le titre du rapport, ce qui peut engendrer une erreur de diagnostic potentielle de l‟état du patient.
 n the extent of the lead damage and the need to use the affected lead contact(s) and/or conductor(s), lead replacement may be required. / À
 révision du texte d‟un rapport, il se peut que des groupes de mots additionnels ne soient pas générés comme prévu dans la mise en garde
nstallation ou service, ou encore se déformer en cours d‟utilisation. Cette situation peut provoquer une inclinaison et entraîner la chute du bra
 venablement.
 lsulfonate de zinc par la méthode AP008 sur la feuille de données DS008, les résultats indiqués étaient inférieurs aux résultats réels.
sonance magnétique (IRM) peut différer le retour à la perfusion normale du médicament après l‟IRM.
nctionnement potentiel en utilisant la plate-forme d‟imagerie médicale Syngo peut survenir et, par conséquent, comporter un risque pour le p
Une désinfection en profondeur des endoscopes Pentax de série 70 à l‟aide d‟un jet d‟eau propulsé dans le dispositif de retraitement automa
 e plaies par pression négative ne réussit pas à recharger suffisamment la pile d‟une pompe.
 e réactif Bilirubine totale qui utilise le processus d‟attribution des valeurs instauré comme mesure corrective à la suite de l‟alerte FA10AUG2
ed. / La friction exercée pendant le fonctionnement expose le câblage de l‟unité pneumatique. Le câblage ainsi exposé est susceptible d‟élec
 de la soie tressée traitée noire 4-0.


 Le lot touché a été fabriqué avec de l‟eau à 23 ºC, une température supérieure à la température maximale spécifiée de 22 ºC. Avant la fusio
 dié avec l‟automate M2000SP ou comme pièce de remplacement, peut avoir des bords coupants.


e RG-316 s‟est avéré ferreux et, par conséquent, composé d‟une substance magnétique plutôt qu‟à base de cuivre. Le câble coaxial est utili
 / Les plans de traitement du logiciel concernant une structure très petite (volume inférieur à 2 cc) située dans une région ayant un gradient d


mise en garde informant les clients que le protocole de balayage numérique « coronaryCTASeq » n‟est pas synchronisé avec l‟ECG du patien
mode d‟emploi est inexact : les sangles verrouillables peuvent être utilisées conjointement aux brassards de cuir synthétique pour créer une
 ne augmentation du trafic sur le réseau.
es données sur la disposition du support d‟échantillons pour l‟application non gynécologique (version 2.8) de la gestion des représentations g
 nomaly has been identified. The slice visualization of VolumeRAD exams acquired on the Wallstand receptor will be offset by 17mm. / Sujet


en raison d‟une légère concavité de la surface du détecteur.
érile de la société BD Diagnostics peuvent présenter une croissance moindre ou nulle de la levure Candida albicans 10231 à une températur
te. / Les trousses peuvent contenir l‟agent de neutralisation des virus B positif et A négatif, mais l‟étiquette indique erronément qu‟il s‟agit du
ère PROFlexx de la société Ferno sont susceptibles de présenter une fatigue du métal et de se fracturer après une à deux années d‟utilisatio
ental HeartMate II doit être remplacé pour empêcher la séparation du point de sortie flexible au connecteur.


du personnel ont observé une décoloration le long des brins du câble tressé. Selon les résultats obtenus d‟autres évaluations et tests, la déc
es niveaux élevés de salicylate sur le détecteur de chlorure. L‟interférence n‟est pas décelable au début, mais elle augmente au cours de la d
command. / Les plate-forme Access et Access-2 (avec la mise à jour de APF d‟avril 2007) qui exécutent le test sur les bêta-HCG sont susce
   2-lancement du nouveau porte-seringue d‟héparine;

el;
                                                3-lancement du nouveau manuel d‟utilisation et de la nouvelle étiquette du produit.

e des plaques a été retrouvée, l‟autre pas.
à jour du logiciel, version VE31 / 2008C, présente des améliorations qualitatives de l‟application Dual Energy (ablation osseuse, contraste vir
ur rotatif peut être compromis, ce qui entraîne une suite de problèmes avec les composantes. Le risque dans cette situation comprend le no


 slucide pour les incisives semblable.
stème Phoenix.
 tte défaillance est la contamination de la matière première de l'arbre pivot qui retient la traverse.
 h stem. / Au cours de l‟assemblage peropératoire, des utilisateurs ont signalé avoir eu de la difficulté à insérer la cupule dans la tige huméra
 ‟ensemble à trachéotomie Portex Blue Line Ultra (étiqueté 15 mm, canule fenêtrée à joint souple de 7,0 mm) a été emballé avec les tubes à
ped. / Une composante de la carte de circuits imprimés utilisée dans l‟appareil peut provoquer un déplacement de l‟icone du cathéter d‟ablati
esterase. / Lorsque la solution témoin Synchron est utilisée avec le réactif Synchron cholinestérase, on observe un échec du témoin. La solu
re fourni ne peut être fixé au cathéter d‟ablation Halo 360 ou au ballonnet de mesure Halo 360. Un lot de filtres avait un mauvais raccord Lue
 / Mise à jour sur la sécurité de la manette multifonctions sur le pupitre de commande à distance. Il est possible qu‟en cas de déplacement in
R/VR devices. / La configuration logicielle du modèle 2490C peut altérer certaines transmissions sans fil par le système Carelink de Optivol C
s de l‟ensemble d‟étalonnage 10 de Vitros Chemistry Products (lot 0198) expédiées entre le 8 août 2008 et le 16 octobre 2008 ont été entrep
La société Bio-Rad recommande de revoir attentivement le rapport sommaire afin de repérer les duplicatas de numéro de la position du tube
n days. / Les ensembles de circuit respiratoire pour adultes RT240 et RT340 fabriqués le 27 juin 2008 ou avant cette date comprennent un c
dèle maxi 500. La goupille a ressort prévenant le dévissage de l'arbre pivot était manquante.


 . / Il existe une possibilité que le couvercle protecteur en plastique qui recouvre l‟interrupteur du support mobile du TDM sur la boîte de conn
plus éloignée que la date de péremption imprimée sur les sachets de gelée lubrifiante à l‟intérieur de la trousse.
urgicale du genou.


ckage. / La société Smiths Medical International s‟est rendue compte que la pointe de certaines aiguilles contenues dans certains lots des e
s lits se détériore avec le temps, ce qui peut entraîner un risque de chute pour les patients ou de blessure pour le personnel.
 distance à utiliser dans un environnement stérile peut être insuffisante pour empêcher la déchirure du sac ou son ouverture pendant l‟utilisa
artMate II doit être assorti d‟une trousse de réparation / de remplacement pour empêcher la séparation du point de sortie flexible au connecte
 fs des tests salivaires ainsi que la solution d‟étalonnage de la valeur limite donnent des résultats hors spécifications pour la concentration en
ans le panneau d‟étalonnage, il est possible pour les utilisateurs de catégories « utilisateur privilégié » (superuser) et « ingénieur service » (f
d serial numbers. / Notre fournisseur Oscor Inc. a connu des difficultés avec l'insertion des fils d‟électrodes de stimulation dans la tête du stim
 t est plus tardive que la date de péremption inscrite sur les compresses Sali_wipes comprises dans la trousse.


 ment du réactif du lot 32892 du Corqc Test System visant les érythrocytes présentait une couleur inattendue attribuable à une contamination
xpected. / Lorsque le mouvement de rotation du bras de la caméra à rayons gamma ou de la table n‟est pas en équilibre et que le signal d'e
 arte de circuits imprimés du commutateur au pied présente un défaut de fabrication. Si la table reste branchée lorsqu‟elle n‟est pas en usag
 lie pouvant provoquer par intermittence une interruption du traitement des analyses, ce qui pourrait avoir une incidence sur les résultats.
 e. / Les pompes à galet n‟ont pu démarrer ou se sont arrêtées de manière imprévue en raison d'un problème lié à la qualité d'exécution du t
t de manière inégale et affichent des erreurs de vitesse de perfusion excessive ou insuffisante; dans certains cas, une accumulation de grais
ge présentent divers défauts de fonctionnement, dont un affichage altéré, un bouton de réglage de la vitesse difficile à ajuster et la perte du c
u des plaintes à l‟effet que certaines fioles du lot 236036 de WB Corqc avaient été affectées par l‟hémolyse. Une enquête a confirmé la prése
 taines circonstances empêcher des images de s'afficher sans que l'utilisateur en soit avisé par un avertissement ou un signal sonore.
Des limites de perfusion « sur mesure » (pré-programmées à l‟usine Curlin selon la commande-client) sont supprimées lorsque la pompe se
 / Des vis de longueur inadéquate ont été utilisées pour assembler les instruments. Comme les vis sont trop courtes, le support de fixation à
ctuosité du logiciel peut entraver le bon fonctionnement de l'alarme qui devrait être déclenchée lorsque le patient bouge ou quitte son lit. La d
des. / À la suite d‟une enquête interne, OCD a mis à jour les valeurs d‟étalonnage pour les Vitros Chemistry Products Prot Slides. On deman
ont l‟objet d‟un rappel parce que le vérin du dispositif pourrait se séparer lorsque le bras supérieur est déployé au maximum, ce qui pourrait p
Architect C16000 intégrés à un APS ne génèrent pas systématiquement une erreur de type LAS 19. Une contamination causée par un résidu
/ml figurant sur l‟étiquette du AccuTnL QC (A31022A) est erronée et devrait plutôt être ng/ml. Cette erreur d‟étiquetage n‟affecte pas la fonct
 é comme étant de 4,9 mL alors qu‟il devrait être de 4,09 mL. La mention actuelle du volume de remplissage du réactif n‟est pas nécessaire


 teur, plutôt que la version 0719I0166.
 Lorsqu‟un test dont le résultat connu est versé au dossier d‟un patient soit au moyen d‟une connexion, soit manuellement par l‟entremise du
rchitect C16000 intégrés à un APS ne génèrent pas systématiquement une erreur de type LAS 19. Une contamination causée par un résidu
 sure de l‟électrode qui raccorde la pompe Heartmate II au contrôleur de système externe peut causer des interruptions de fonctionnement d
pel de modèles et de lots précis en raison du risque de fuite à la jonction du cathéter à ballonnet et de la lumière. La fuite pourrait contribuer
 unications. / Un problème de contact entre le U25 IC et sa prise peut entraîner une erreur de communication au moment de la mise sous te
e pour ions spécifiques (EIS) du Cobas 6000 peut présenter une sous-estimation des résultats des témoins et des échantillons des patients e
n Pump 2 Blockaid présente une défectuosité du contact de la pile, ce qui provoque une perte momentanée de l‟alimentation. Une baisse du
aux de faux positifs obtenu comparativement au taux observé avec les lots précédents de ce produit.
 ner lumen. / La société Smiths Medical Canada a expédié par mégarde une petite quantité de produits qui avaient fait l‟objet d‟un rappel (n°
ple. / Ce lot est contaminé. L‟utilisation de ce produit pourrait entraîner la contamination du milieu de culture. Il est possible que la croissance
 age. / Un problème est survenu lorsque l‟examen du patient a été réalisé dans une autre position que couchée. Si les images sont sauvega


achines. / Une défectuosité du logiciel entraîne un changement de la symétrie des mâchoires dans les plans de radiothérapie conformationn
suite de la plainte d‟un client, il a été établi que l‟utilisation de la sonde LSI FUS Breakapart peut produire un modèle de signal inhabituel pou
 la température cible du VP 2000 avait été dépassée et que le système d‟affichage de la température ne pouvait pas indiquer la température
e peut donner une fausse indication de résistance au test de sensibilité amoxicilline / acide clavulanique. L‟utilisation de ce produit pourrait d
 ntrol procedure. / Le produit peut être responsable d‟un allongement du temps de réaction. Ce temps de réaction peut se situer en dehors d
can vary up to 2c. / Le fabricant du produit a reçu des signalements de température corporelle élevée chez certains nouveau-nés soignés su
aced. / Les réactions obtenues à l‟aide de la trousse peuvent se révéler lentes et faibles. Une vérification préliminaire a montré que toutes les
ans le cas de l‟examen néonatal de la tête avec le transducteur C8-5. L‟ITC est nécessaire pour maintenir le principe ALARA pendant la prise d‟images de
ly. / Dans le cas d‟un plan de traitement contenant une séquence de faisceaux dont au moins un faisceau en arc, si la séquence est terminé
 bloc de coupe avec échelle indique que le matériau qui le compose est de l‟acier inoxydable et du téflon, alors qu‟il s'agit en fait de Propylux
 cteur (partie femelle) et/ou le filage interne de la batterie produise un court-circuit.
g. / L‟appareil peut ne pas déceler qu‟une injection se produit sans le transfert de peroxyde d'hydrogène dans le vaporisateur. Il est possible
pération des données du témoin et un étalonnage invalide en raison d‟une dérive du facteur d‟étalonnage.
e qui provoque un déplacement de l‟étendue de référence des valeurs de calibration acceptées.
volution Formula 2 indique par erreur la teinte B2, mais les seringues à l‟intérieur du paquet sont étiquetées A2 et contiennent la teinte A2. C
En raison du desserrement d‟un palier de l‟interrupteur à pédale, l‟utilisation continue peut déloger du montage le ou les ressorts situés sous


red is correct. / La quantité de bolus prolongé affichée comme étant administrée sur l‟écran de la pompe et par le rapport sommaire peut êtr
tervention chirurgicale.
e clients au sujet de la stabilité du témoin de qualité de Advia Centaur Systems BNP (peptide natriurétique de type B) 1, 2, 3 montrent que le
 ne mauvaise technique opératoire a été utilisée et a provoqué le bris de la pointe du tournevis qui s‟est coincée dans la tête de la vis. Un rap
 c. / La société a reçu des plaintes au sujet de la stabilité des solutions d‟étalonnage et témoins de Irma SHBG, qui ne respectent pas les cr
tériau à empreinte dentaire, Take 1 Advanced Volume FS, a été rappelé à la suite de plaintes selon lesquelles le produit prenait trop de tem
 rtant le numéro de lot PFFA211107 ont été étiquetées PMF20 100 10CS, elles auraient dû porter le code PMF20 100 10CS/l.
erator. / La génératrice haute tension peut cesser de fonctionner empêchant la production de rayons X et l‟affichage de l‟image. Après la réin
 yzer to PSM. / Limites du système de gestion des processus (logiciel PSM) lorsqu‟il est utilisé avec les instruments modulaires de Hitachi. L


tomographie par ordinateur (augmentation de l‟ampérage [mA]) en mode de synchronisation prospective, lorsque certaines interventions son
t dose. / Lorsque l‟appareil est utilisé avec le détecteur plat, dans des situations particulières utilisant des tensions supérieures à 115 kv, il es
on. / La gaine interne en nylon peut dépasser de l‟extrémité du ballon de la canule de silicone de 0,57 à 0,76 mm et peut rendre le bord légèr
ers. / Le système logiciel CELL-DYN Ruby (v 1,0 ml et 2,0 ml) ne respecte pas les données sur le pourcentage de contamination publiées da
ge et le revêtement intérieur étaient étiquetés 32 mm, mais le revêtement de 32 mm ne s‟adapte pas à la tête de 32 mm. Le diamètre intérie
aintes au sujet d‟erreurs d'étalonnage et de résultats de la cartouche de réactif Flex Ferritine, pour le système Dimension Vista. Environ 11 %
 c. / La société a reçu des plaintes au sujet de la stabilité des solutions d‟étalonnage et témoins de Irma SHBG, qui ne respectent pas les crit


 isolats de Shigella sonnei ont été identifiés comme étant Escherichia hermanii par la carte Vitek 2 GN. Ces souches de Shigella sonnei son
orsqu‟on met l‟angiographie numérisée rotationnelle (DRA) en fonction, le logiciel de géométrie peut, par intermittence, cesser de fonctionne
 e une défaillance partielle de la grille de rotation qui peut entraîner une plus grande libération de rayonnements que prévu. La défaillance po
 nts sont intervenus dans les méthodes de nettoyage et de stérilisation des palettes et des fixations de palettes pédiatriques utilisées avec le
mplemented. / Les fissures microscopiques qui se forment dans les godets en métal des centrifugeuses utilisées dans le module de centrifu
 e rayonnement que prévu.
e a été envoyée aux clients sans mode d‟emploi. Les forets 915 3008 ou 915 3009 contenus dans la trousse sont destinés à un usage unique
h. / La gaine jaune de protection du ballonnet du dispositif de 4,5 mm de diamètre est serrée. Si l‟utilisateur ne s‟en aperçoit pas, le ballonnet
s Invacare peut exposer les utilisateurs à un risque accru de coincement.
e sortie du transducteur du système de soufflets peut provoquer une défaillance dans la production des images liées au cycle respiratoire.
. / Le dispositif XIO est sensé recalculer la distribution de la dose pour la forme de la fenêtre mais pour une série d‟étapes en particulier une
solutions témoins fraîchement préparées donnent des résultats dans les limites prévues, mais les résultats augmentent le jour suivant et ne
a) de canules de drainage DLP Pericardial/Intracardiac sont rappelés parce que l‟extrémité du drain peut se séparer de la tubulure au cours d
ées du système et des câbles électriques laissés en place. Si ces câbles entrent en contact avec du liquide d‟amorçage, le débordement peu
 extrémités en acier inoxydable des dispositifs touchés (sonde à crochet, sonde à angle droit, sonde à aiguille) se dégradent, entraînant la lib
n entre la version française du logiciel ezManager Plus et le guide de l‟utilisateur.


 voquant un arrêt préventif des mouvements du lit.
ompre le mouvement permettant de retourner le patient fonctionne par intermittence. Cette situation peut empêcher le soignant d'effectuer l
 ociété a reçu des plaintes de clients au sujet d'une légère augmentation de la fréquence de résultats positifs dans l‟intervalle des valeurs seu
e units. / L‟étiquetage de l‟appareil Eclipse SW ne comprend pas d‟information sur l'effet des mises à jour sur la conservation des valeurs sé
 ioning errors. / Des erreurs de type SW entre les systèmes Impac Multi Access ou Mosaic et les versions OBI 1.0.15 et 1.2.05 avec un troisi
 cartes des systèmes Vitek 2 incluses dans Observa ne comprennent pas toutes les limitations des sensibilités aux antimicrobiens de Vitek

 petites quantités de sulfate de chondroïtine trop sulfaté présentes dans l‟héparine. La contamination n‟a pas affecté la qualité, l'efficacité ou

 pack était incorrectement étiqueté sous le nom K3 engine file VTVT pack. De plus, une des lames portait l'inscription .20 gravée au laser, m
. / Erreur de logiciel (SW) dans le logiciel graphique Aria SW RT. Le logiciel Aria Radonc 8.1 doit valider tous les champs du collimateur mul
 properly. / Le logiciel Varis comporte un défaut de fonctionnement qui, non détecté, pourrait entraîner l‟administration d‟une dose pouvant êt
ph AP ou ceph PA du volume de Galileos 3D est générée dans Galaxis et imprimée par Galaxis ou Sidexis, la copie montre un repère latéra

uite de 8 à 6 semaines sur toutes les plate-formes porte-instruments.
 igurant sur les étiquettes préimprimées des tubes est erronée et devrait être « LH Lithium Heparin ».
a société Source Medical procède au rappel du Cardinal Sterile Pack parce qu‟une composante de l‟ensemble d‟administration de l‟agent de
 IBP) chez les patients dont la pression est de 230 mm Hg et plus.
e nettoyage, de désinfection et de stérilisation sont inadéquates ou incomplètes. Le fabricant a émis un avis à l‟intention de tous les clients e
  stylet se détache de celui-ci.
B) figurant sur l‟étiquette extérieure de la boîte du réactif Access DHEA-S est erroné. Le flacon de réactif contient en fait le volume correct, soit la quantité
  Dans un petit nombre d‟unités d‟oxygène liquide comprenant l‟indicateur de niveau de liquide de 4e génération, la présence d‟humidité dans
 s puits des tests Capture-R Ready-screen et Ready-ID présents sur la plaque pendant les étapes du processus, mais pas utilisés pour un te
vec des bandes précédemment utilisées pour équilibrer avec l‟essai subséquent Capture-R Ready-screen (3).
 ed. / L‟unité d‟alimentation de l‟appareil qui contrôle l‟exposition aux rayons-X peut tomber en panne sous l‟effet répété des forces centrifuge
   / L'incidence de la désolidarisation de la canule et de la glissière de déploiement de la poignée des cathéters est plus importante que prévu
   les réactifs des trousses pour le test de dépistage des amphétamines (lot no 15606300) utilisés avec les analyseurs Roche Hitachi et Cabs
nt, une notice imprimée d‟un seul côté a été insérée dans 45 unités du produit et est donc incomplète.
  reen. / Les médicaments qui ont un statut inactif ne sont pas reflétés dans tout le système, à savoir dans les plans de soins, les écrans de s
mage est calibrée avec un cathéter de la mauvaise taille; cette calibration incorrecte peut mener à une erreur de mesure.
er les doigts entre certaines parties du lit (sous le lit, entre les ridelles) au moment d‟adapter le dossier du lit, ce qui pourrait entraîner des ble
u test Access HAV AB a dérivé avec le temps, entraînant une surestimation de 20 à 30 % des résultats des patients avec le lot de calibrateu
e du test FT4 Access a la mauvaise date de péremption intégrée dans le code à barres. La date de péremption est correctement imprimée s
 il Aristos FX. Une inspection visuelle devrait être effectuée afin de déceler toute vis d‟assemblage qui risque de se desserrer.
  bles Attain peuvent être mal scellés ou manquer de rainures dans le sceau, ce qui pourrait compromettre la stérilité du produit.
u d'indice thermique (IT) incorrectes ou pourrait ne pas afficher les indices lorsqu‟il le devrait.
u d'indice thermique (IT) incorrectes ou pourrait ne pas afficher les indices lorsqu‟il le devrait.
 plastic lid. / Certains défibrillateurs externes entièrement automatisés ont été configurés par erreur comme des défibrillateurs semi-automatiq
  EMI. / Les rallonges Ophit DVI (composante de l‟appareil) ne répondent pas aux exigences en matière d‟immunité contre les interférences é
 in into the corner casting. / La société Ferno a reçu des pièces de coin d‟un ancien fournisseur avec des trous coniques surdimensionnés, ce
a stérilité du produit pourrait être compromise.
 ave (courbée vers l‟intérieur) plutôt qu‟une lame convexe, conformément à la conception de ce produit.

 s a reçu des plaintes au sujet des règles Trugene HIV-1 Guidelines 12.0 et 13.0 (une composante du logiciel Opengene) qui donnent des in
 bias. / La société a confirmé l‟existence d‟un biais positif non linéaire sur les résultats obtenus avec la trousse Progestérone. Les valeurs so
certaines unités présentées dans des emballages stériles et leur stérilité ne peut donc pas être garantie.
ui se forment dans les godets en métal des centrifugeuses utilisées dans le module de centrifugation (Centrifuge Module, CM) du système de
 e sur l‟étiquette est incorrecte et aurait dû être 266. Seule la méthode semi-quantitative est affectée.
er les doigts entre certaines parties du lit (sous le lit, entre les ridelles) au moment d‟adapter le dossier du lit, ce qui pourrait entraîner des ble
  des tests de contrôle de qualité de routine effectués après le lancement, les produits de ce lot ont fait preuve d‟une tendance à manifester d
ce négative sur le plan de la stabilité pourrait entraîner une diminution importante dans les pentes des ajustements (réduites à 0,7) et un déc
 rticulière qui pourrait potentiellement faire en sorte que la luminosité de l‟affichage soit réduite et que l‟affichage cesse éventuellement de fo
concernant des taches sur les sachets en Tyvek ou sur le couvercle. Une enquête menée sur les plaintes formulées sur les produits retourn
 er que le mode service doit seulement être utilisé par le personnel autorisé et que des modifications non autorisées ou faites au potentiomè
rappel important en matière de renseignements concernant la sécurité. La lettre contenait des renseignements qui ne figuraient pas dans le
 uette indique « postopératoire pour urostomie ». L‟étiquette devrait indiquer « postopératoire pour colostomie ou iléostomie ».
 ne absorption de fond.
mboles sur le côté et sur les rabats de chaque boîte de IntraStent sont inversés – le symbole pour le diamètre et le symbole pour la longueur

x déplacements de filtres ont été signalés en France. Le fabricant indique que les déplacements sont probablement attribuables aux circons
 nneau de circuits du processeur de signaux numériques du réflectomètre dans le système Vitros 5,1 FS est tombé en panne, et ce condens
e fraisage contenus dans l‟emballage pourraient être incorrectement marqués comme étant de teinte E (émail) plutôt que d‟être de teinte A1.
ciel Selenia V.3.3.1.1 comportait un facteur d‟amplification qui faisait en sorte que les marqueurs d‟aide à la détection n‟avaient pas été placé
m. / Renforcer les instructions d‟utilisation actuelles concernant le détachement de la capsule du système de largage et fournir de plus ample

  . / Les deux produits ont gelé durant leur expédition à Roche Canada. La cocaïne et la gentamicine sont sensibles au gel. À une températur
s lames chirurgicales HallMD de la société Conmed Linvatec portant certains numéros de catalogue et de lots pourraient avoir un ou des trou
 me restauratrice de l‟implant, laissant un espace entre la coiffe et l‟implant.
 îne de transmission du collimateur peut casser ou glisser de sa voie d‟entraînement, permettant au collimateur de glisser ou de tourner libre
ant un collimateur multilame dynamique pour un traitement de radiothérapie à intensité modulée ne seront pas reconnus par le système. En
  désinfection (touche F8).
  No 765291 pourrait avoir été emballée en tant que LOA003, lot No 765295, et une partie de LOA003, lot No 765295 pourrait avoir été emba
akpoints. / La surveillance par bioMérieux du produit de Vitek a permis la détection de CMI élevées. Cela pourrait entraîner une interprétation
 est wedge). / Une erreur de programmation dans le PBC 8.1.14 et 8.1.17 fait en sorte qu‟un accessoire de calage ajouté dans le champ d‟un
 semblage du mât ou mât de charge.
ches de réactif de certains lots présentent un manque de précision qui pourrait entraîner des résultats faussement élevés. Des résultats allan
  ajoutée à la source Elekta Synergy KV afin de renforcer les dispositifs de sécurité du système Elekta Synergy.
yage 1, ce qui peut avoir une incidence sur les résultats.
e » sur les directives d‟utilisation des aiguilles Phaco non stériles et réutilisables.
  e. / Pour communiquer aux médecins de nouvelles informations sur l‟incidence post-commercialisation actuelle de masses inflammatoires à
Le condensateur au tantale a été installé à l‟envers lors du montage, ce qui peut entraîner des pannes prématurées. La panne peut avoir pou
e. / Lorsque le cathéter est entièrement fléchi et que la boucle variable est complètement tendue, il est possible que le mécanisme de cathét
Un certain nombre de valves ont été incorrectement suturées au système de porte-valve. L‟erreur rend la séparation de la valve de son supp
 irurgie Valleylab Force FX-CMD.
53-01) qui présente l‟algorithme de diagnostic proposé pour la maladie de Crohn soupçonnée contient une erreur. Les symboles (+) et (-) son
al geometry. / Mesures par reconstruction multi-planaire (quadrants de reconstruction multi-planaire 2D) acquises par balayage 3D en mode
  ur définit les mesures d‟inspection additionnelles s‟appliquant à tous les types d‟aimants OR24 et OR70 (Harmony et Symphony) mobiles en
  olé de la lame chirurgicale Conmed Livatec Hall de la trousse Cardinal pourrait être perforé dans les coins, ce qui peut compromettre la stér
  ions auxquelles est soumis le câble de connexion du capteur de spirométrie interne (Spirolog) et le connecteur pourraient entraîner la désol
dans la version 5.02 pourrait avoir donné lieu à des résultats incorrects (faux positifs ou faux négatifs). Corruption de la mise en mémoire de
xamen rétrospectif d‟études portant sur la stabilité de l‟emballage a mis en évidence la présence de perforations dans l‟emballage primaire d
cessif de liquide durant le traitement d‟ultrafiltration et pour diminuer la possibilité que cette situation se reproduise.
  ièces que contient l‟emballage. L‟emballage ne comportait qu‟une seule pièce plutôt que six.
 indiqué que la sensibilité du réactif a diminué et cela risque de produire des résultats faussement négatifs pour le HCG. La durée de conserv
  lf life. / La société Bio-Rad a noté que la performance des lots susmentionnés pourrait être affectée: la troponine T n‟est pas conforme à l‟al
26, 2007. / Augmentation des taux de reprise pour l'implantation de prothèses contenant des composants de polyéthylène stérilisés
Georg Kramer est facile à déverrouiller de façon à faire retomber l‟appuie-dos.
nne du dispositif. Dans certains cas, une odeur de brûlé se dégage de l‟intérieur du dispositif.
 ccuracy. / L‟absence d‟un programme de maintenance préventive peut avoir un effet sur l‟utilisation sécuritaire de l‟équipement durant le tran
dossier du patient pourraient indiquer le mauvais nom de produit, c‟est à dire, Amplatzer Septal plutôt que Amplatzer PFO. L‟étiquette extérie
  / La présente fait suite à une plainte en provenance d‟un client selon laquelle le manuel de l‟opérateur comporterait une erreur d‟étiquetage
 orté un nombre plus grand qu‟escompté de valeurs non réactives pour les échantillons réactifs de faible niveau durant un essai interne ayan
 sure (NBP) mode. / Il est possible que certains utilisateurs aient présumé que les alarmes techniques SpO2 non-pulsatiles et sans capteur é
 e par la suite la pile surchauffe, qu‟elle se fende ou qu‟elle dégage une odeur désagréable.
 ousses de stabilisation du poignet pourraient avoir des ouvertures ou des vides et ainsi compromettre la stérilité des produits. Pourtant, le pr
ualité interne a confirmé que la linéarité de l‟ensemble n‟est pas conforme à celle prétendue de 11,4 mmol/L. Un examen approfondi a déterm
mponents. / L‟unité de conditionnement d‟énergie peut subir une panne et dégager de la fumée ainsi que de la chaleur. Les unités sont conte
ments are incorrect. / Lorsque l‟opérateur utilise les fonctions de distance ou de mesure de la surface pour des images agrandies et sauvega
 high battery impedance. / Le fabricant a remarqué un type de comportement récurrent du dispositif dans lequel les messages ERO et EOL s
 eleased. / Le doigt d‟un jeune enfant a été sectionné lorsque ce dernier jouait autour du côté droit du lit. Il a fallu que l‟enfant place volontaire

que celui-ci est conservé dans le dispositif Elecsys.
  to fall. / Le service de gestion des services de santé de la société Tyco a été informée de pannes affectant les systèmes de suspension CT
  to fall. / Les vis retenant la pince Mavig Powerhead (appelée j-blow) sur l‟OptiVantage DH peuvent se desserrer. Dans certains cas, cela pe
 est telle que le programme ne pourrait pas fonctionner. L'appareil ne pourrait pas analyser des hémoglobines A2 avec un programme destin
nti-S pour la détermination des groupes sanguins pour les tests de Coombs indirects ont fait l‟objet de plaintes concernant une réactivité amo
 s inférieures de 20 %, peut être observé dans le pourcentage de la CDT (transferrine déficiente en carbohydrates) pour les numéros de lot a
a été signalé que les produits comportant le code 210711 (lot no 3069512) auraient fait l‟objet d‟un problème d‟assemblage durant la fabricat
ulation sanguine durant l‟utilisation.
atériel du mécanisme position haute / basse utilisé pour soutenir la partie supérieure peut céder et faire tomber la partie supérieure à la posi
 . / Tel qu‟allégué, la stabilité du bicarbonate dans les sérums témoins reconstitués Precinorm U Plus et Precipath U Plus ne peut être obtenu
s utilisés pour le transport des supports de greffon n‟ont pas été scellés avant la stérilisation. Il est possible que le scellage à l'extrémité du s
nage erronée pour le magnésium CAL 2 (CAL 2) a été fournie pour un lot. La valeur inscrite sur l'étiquette est 3,2 mEQ/L; il faudrait plutôt lire
 le dispositif de calcul cardiaque de SyngoDynamics pour réaliser certaines mesures de l‟intégrale temps-vitesse (ITV) au poste de travail Sy
 nt de la carte de circuits imprimés peut entraîner une défaillance du ventilateur assistant la respiration du patient (vent inop) et (ou) une défa
te du contact dans le connecteur et il est possible que la pile ne se charge pas correctement.
 Des lettres de mise en garde ont été envoyées aux clients pour les aviser que les charnières des portes de la structure fixe peuvent s‟user a
ow 3.0 mg/l. / Le fabricant a confirmé la présence de résultats faussement élevés de RCRP lorsque les échantillons de plasma proviennent
 qué avec le matériau original. Ce changement s‟est révélé important et la licence n‟a pas été modifiée.
 ophilus influenza. L‟absence de croissance sera évidente une fois comparée à la croissance sur la gélose chocolat qui accompagne la cultu
 hine. / L‟information relative à la diffusion du rayonnement dans le manuel d‟utilisation de l‟appareil I-Cat doit être corrigée. Les nouvelles va
sur mesure comprenant une composante Zimmer Hemovac Systems en raison de la présence possible de trous d‟épingle sur certains sach
ient apposés sur des images provenant d‟un autre patient en raison d‟une défaillance du logiciel.

s lors de l‟utilisation de produits BD Tensor Heat Therapy.
ptible de faire en sorte que la cartouche entraîne la formation de lignes d‟agrafage incomplètes.
uette donnent la longueur de l‟enroulement en mm, toutefois la longueur devait être indiquée en cm. Le numéro de catalogue et les dimensio
me n‟affiche pas les bonnes valeurs de l'indice mécanique (IM) et de l'indice thermique (IT) ou peut ne pas donner les indices lorsqu‟il devrai

y. / Le fabricant a reçu des rapports de clients l‟informant que les stérilisateurs Sterrad émettaient une bruine produite par une défaillance m
il. / Les méthodes de stérilisation décrites sur l‟étiquette peuvent être inefficaces et peuvent endommager ou corroder les électrodes. Dans le
nsemble 6 FR permettant l‟introduction du cathéter de stimulation cardiaque temporaire 5 FR (110 cm) ne contient pas d‟ensemble introduct
  . / Un fournisseur a étiqueté par erreur un lot de piles Fastpak ayant une capacité de 1,0 ampère-heure avec le numéro 3009376 004 NI CD
  ajoutée à la source Elekta Synergy KV afin de renforcer les dispositifs de sécurité du système Elekta Synergy.
En raison d‟une erreur de conditionnement, un faible nombre d‟articles d‟un lot de dispositifs servant à préparer et à appliquer le ciment acry
  Dans le tomodensitomètre Aquillion One, il est possible que la fonction SureStart ne fonctionne pas normalement; il se produit aussi parfois
  h test results transfer message, e.g. record ID 16 = HGB for hemoglobin. Above the table listing the mapping data, a statement exists that s
 sage to the operator console for service. In some replaced or adjusted switches the error is not displayed and normal table operation is allow
 / Une enquête interne indique qu‟il pourrait y avoir un problème de fiabilité dans le lot concerné. On a découvert que certaines plaques ELISA
ment positifs en employant le système Advia Centaur pour la détection du virus de l'hépatite A et de l'IgM, ce qui peut amener de la confusio
cuit. / Les coussinets de détection de niveau se détachent de la surface du réservoir veineux. Ces coussinets sont des dispositifs à usage un
(8_5101) n‟ont pas subi, en tant que test préalable au lancement de la fabrication, d‟essai de détection des endotoxines à l'aide du test LAL
 ide de la fonction de reconstruction multicoupe native de Isite pourraient être mal orientées si le patient est placé pour la tomodensitométrie
/ Il y a un bogue dans le logiciel du XIO; c'est-à-dire qu'il y a divergence entre l'intensité du faisceau et la dose affichées. Lorsque l'intensité d
nt une hémolyse importante ou une couleur inattendue.
 les instruments équipés de la version 2.0.9, ou d‟une version précédente, du système.
 ator with CBAS. / Deux lots d‟héparine contaminés par du sulfate de chondroïtine persulfatée ont été employés dans la fabrication de certain
 el (rouge) au dialyseur, ce qui pourrait présenter un risque d'hémodialyse pour le patient.
que dur de certains appareils OEC 9800 entraîne une défaillance précoce du disque dur et l‟empêche de stocker correctement les images.
  sage. / Plus grande fréquence d‟apparition de certains messages d‟erreur, p. ex. « on-board QC out of range try again » ou « sample not se
 s lots de Cardiac Troponin I (cTnI) Calpaks (CCTNI-CR) présentent un défaut d‟étalonnage en lien avec la date d‟expiration. Les TestPaks C
uent de descendre de manière inattendue jusqu‟à leur position la plus basse lorsqu‟on ajuste la position verticale; après cela, le mouvement
ue l‟outil SUV donne différentes valeurs de fixation normalisée (MAX SUV) pour une petite tumeur selon que les images de la TEP soient ou
 nt susceptibles de ne pas s‟illuminer sur toute leur longueur; une mauvaise visibilité des structures urétrales en cours de chirurgie peut en ré
  Des erreurs de mesure peuvent se produire lorsqu‟on utilise le logiciel d‟analyse de sténose. Si la fonction Innova Sense Patient Contouring
ss. / La partie centrale de la composante peut se desserrer et (ou) se détacher du boîtier de l‟adaptateur. Si le centre devait se desserrer ou
  t. / Les composantes de l‟aiguille d‟électrochirurgie Conmed des ensembles stériles préparés pour Cardinal Health sont emballées dans un

artefacts, à des arrêts sporadiques du balayage, aux téléchargements à distance et à la révision des cartes électroniques ETX.
  préparation microscopique faite avec l‟échantillon du patient suivant lorsque le taux de globules blancs est d‟environ 90 000/UL.
 porté des mouvements involontaires du support du tube qui vient s‟appuyer sur le patient pendant que celui-ci est sur la table d‟examen. Le
 nation. / Dans certaines circonstances, des images uniques provenant d‟autres patients ou d‟autres examens sont déplacées dans le visual
errupteurs a été changé en 2005 et il était disponible uniquement en pièces de rechange. Un des blocs était défectueux et il est nécessaire d
e problem. / Le D Dimer High Control (produit de contrôle D-dimères haute concentration – numéro : 1468, lot R194025) ne permet pas d‟ob
cimen. / Lorsqu'on procède manuellement à la reprise de l‟analyse d‟un lot de tubes non lus, l‟appareil provoque la lyse du contenu des tubes
 lacons des réservoirs d'origine ont été utilisées pour quatre lots de calibrateur. Cette situation a entraîné une diminution d‟environ 6 à 7 % de

elatives à la conformité des normes CEI et corrige plusieurs autres problèmes.
peut montrer le modèle 2500A plutôt que le modèle 2500, le « A » indiquant que l'appareil possède des fonctions d'alarme.
  un entretien de routine de la valve de cisaillement, il est possible qu‟un lavage automatique prévu se produise lorsque la valve est démonté
 ction de Drystar Axys précise que la valeur par défaut pour l‟étalonnage de la pellicule doit être mise à « on ». Un certain nombre d‟impriman
e dans les versions 6.1, 6.2 et 7.0 du logiciel Desktop Pro de la Precise Treatment Table. On a signalé un risque possible d‟erreur (pouvant a
g through the instrument's flow cell declines during the period of data collection. In this situation the WBC optical count (WOC) is recalculate
 èmes de chimie Advia vendus entre octobre 2007 et mars 2008 étaient incorrectes.
 ded. / Les pompes rappelées contiennent l'une des versions précédentes du logiciel d‟application. Par conséquent, il est possible que les ut
mbre limité d‟appareils ont été fabriqués avec un panneau de circuits imprimés pouvant entraîner des pannes intermittentes. Si cette situatio
 Un des fournisseurs n‟a pas respecté les normes du fabricant. Par conséquent, le dispositif risque davantage de se briser pendant son utilis
ulusion. / Des lots fabriqués avec une ancienne version du matériau utilisé dans la composition de la lumière du fil-guide, laquelle n'est pas v
ème relatif au collimateur d‟un système de radiographies qui peut se desserrer et se détacher de son socle.
 iminuée de 24 heures à 8 heures à la température ambiante, de 30 jours à 7 jours au réfrigérateur et de 3 mois à 2 semaines au congélateu
 & tubing packs. / Trois lots d‟héparine contaminée par du sulfate de chondroïtine sursulfaté ont été utilisés pour fabriquer certains lots de pr
 d‟accompagnement du logiciel affirme que certains disques logiciels doivent être installés afin de réaliser le dosage Digoxin II, mais les disq
 i le bouton Suivante est utilisé pendant la phase 2 de la segmentation, le système peut calculer la dose finale avec l‟algorithme du faisceau p
version 1.7 du système RPM. Un défaut peut affecter les traitements de la radiothérapie synchronisée à la respiration lorsque la synchronisa

 ly. / La société Cardinal Health a reçu des rapports selon lesquels le débit du module de pompe à perfusion Alaris était incorrect à cause d‟u
  produire une fluorescence réduite.
  échantillons par codes barres peut se produire si des erreurs ou des défaillances de l'appareil n'étaient pas corrigées selon les directives de
La réactivité et la performance de l'amplichek swab ct/gc control, amplifié positive (contrôle positif pour neisseria gonorrhoeae) peuvent varie
 tation des données sur les interférences lors d'hémolyse ou avec les triglycérides et les héparines fractionnes.



a pompe à insuline Animas 2020.
e du masque pour le calque SmartMask peut ne pas correspondre à l‟image de la fluoroscopie réelle si l‟opérateur change la taille du champ
 ilisation indique qu‟une aspiration plus importante peut être réalisée en effectuant une rotation de l‟aiguille (“needle”) régulatrice dans le sens
  software interrupt handler. / L‟arceau du BV Endura (version 2) s‟éteint subitement durant l‟utilisation de la fonctionnalité optionnelle de co
d. / Il existe un risque de dommage à l‟anneau d‟arrêt sur le piston du moteur Hi/Lo lorsque le lit est en position basse durant l‟utilisation de lè
e numéro du lot indiqué à la fois sur le flacon et sur le feuillet était différent de celui indiqué sur l‟étiquette de l‟emballage.
ar le fait que dans certains cas, il est impossible d‟activer le mécanisme de sécurité du BD Vacutainer. En conséquence, l‟aiguille ne peut pa

lissage, si le système est éteint ou s‟il y a une panne de courant, il est possible que le système n‟enregistre pas les premières à quatre derni
relatives aux fuites lorsque le clamp régulateur de débit en verre a été remplacé par un un clamp coulissant en plastique pour tubulure, ce qu
ff. / Une faille survenue au cours du procédé de fabrication est à l‟origine de petites entailles sous les plis de certains masques, ceux-ci ne p
 valves à trois voies peuvent ne pas être étanches et laisser la solution de nettoyage, qui contient un agent de blanchiment, pénétrer dans le



acons de calibrateurs et des contrôles NH3/ETOH/CO2 (utilisés avec le système Cobas Integra).
 racture de la tige fémorale lorsqu‟une tête fémorale V40 +16 mm est couplée à certaines tiges fémorales Accolade TMZF chez des patients
  à l‟hélium. La fuite déclenche une alarme de perte d‟hélium (« helium loss 2 »). La perte de soutien au patient est intermittente et variable.
eisseria meningitidis ATCC 13090.

  nal. / Il est possible que le système ne reconnaisse pas la position « couchée » lorsque la table d‟examen passe rapidement du mode « libre
  0, n‟a pas reçu l‟autorisation de mise en marché (il est considéré comme un dispositif non homologué) et présente donc un danger potentiel
 rcuits imprimés peut causer un dysfonctionnement intermittent de la pompe et notamment l‟impossibilité d‟initialiser ou de réinitialiser l‟écran
 r. / L'applicateur variable d'électrons numérique (Digital electron variable applicator, DEVA) est conforme à IEC60601-2-1, sauf en ce qui con
 ge des spécifications. Ces écarts varient d‟une tige à l‟autre, ce qui entraîne des différences de courbure entre les tiges utilisées dans les es
és avant ou pendant l‟implantation.
  function. / Dans certaines unités, les câbles des transducteurs étaient déjà tordues, sans toutefois présenter un bris du sceau de colle. Aucu
S4-IR de VISX commençait à monter sans vouloir s‟arrêter.
wed. / Depuis mai 2005, des dispositifs de mesure ont été vendus avec une vieille version du manuel d‟opération plutôt qu‟avec la version m
 ion de licences n‟ait été remplie.
  ans un faible pourcentage de lots de trousses, la bandelette pour l'antigène commun du HSV semble plus claire (moins réactive) que la ban
Un mouvement n‟ayant pas été commandé par l‟opérateur et un mouvement inattendu peuvent se produire avec le bras en forme de U du sy

ransmettre ou faire imprimer les mauvais dossiers de patient.
ue de ralentissement ou d‟aucun dégonflement, ce qui pourrait entraîner une occlusion totale du vaisseau et provoquer une arythmie, une fib
 esidual. / On a découvert que certaines cupules acétabulaires Trident recouvertes ou non d'hydroxyapatite présentaient un taux de résidus
 racture de la tige fémorale lorsqu‟une tête fémorale V40 +16 mm est couplée à certaines tiges fémorales Accolade TMZF chez des patients
  / Retrait des applicateurs endoscopiques d‟agrafes pour ligature (530). Certains dispositifs ELC fabriqués entre le mois d‟octobre 2005 et le
ens tomographiques comprend certaines différences au niveau de la représentation (des points de la 2e étude ne s‟affichent pas comme pré
 passant la limite de manière évidente (DO > 4 000) entraîne l‟émission d‟un signal « 4 000 » qui remplace la valeur attendue mesurée. Ce s
 version 1.7 du système RPM. Un défaut peut affecter les traitements de la radiothérapie synchronisée à la respiration lorsque la synchronisa
 égénérer la structure du dictionnaire des tests combinés (sdive tool) peut, dans certaines conditions, provoquer la perte de données dans le
  signal. / Il est possible que le système ne reconnaisse pas la position « couchée » lorsque la table d‟examen passe rapidement du mode « l
 anisme en Z au bras (ISO-base) ont cédé, ce qui empêche la table électrique de fonctionner.
 ultats erronés avec les cartouches de réactif Flex pour le test d‟azote uréique du sang dans le lot FC8283. Une partie seulement du lot est to

 très rares occasions, donner un résultat faussement faible. Le test QMS® Vancomycin est équivalent au test Multigent® Vancomycin.
Lors de l‟assemblage de certaines seringues, un lubrifiant à base de silicone a été appliqué par erreur sur la pointe du piston et non pas sur
 Quand les valeurs seuils positives et négatives (essai 116 et 117) du test amphétamine ou méthamphétamine de Axsym sont éditées après
 .02, 2.03, 2.10 et 2.11 pour SGI et 2.15 pour Linux du logiciel Precise Plan produisent des radiographies reconstruites numériquement (DRR
ersions 2.00, 2.01, 2.02, 2.03, 2.10 et 2.11 pour SGI et 2.15 pour Linux du logiciel Precise Plan produisent des radiographies reconstruites nu
eated
WBC.
/
Une
contamination
microbiologique
survenue
dans
certains
flacons
des
lots
identifiés
entraîne
une
élévation
du
bruit
de
fon
une arythmie.
 auser des blessures.
  itself. / Il est possible qu‟un bolus non programmé s‟écoule si la porte de la pompe est ouverte puis refermée immédiatement après l‟arrêt d
se à niveau du logiciel, on a constaté que deux séquences de programmation précises peuvent entraîner une désynchronisation temporaire
 lots actuellement sur le marché du réactif IMMAGE CRP présentaient un effet prozone ou crochet (excès d‟antigène). Leurs valeurs se situe

on continue de ces lots de Streptex groupe A peut entraîner une erreur d‟identification des streptocoques n‟appartenant pas au groupe A.
ol. / Si vous utilisez le signe « ) » au lieu de « , » (virgule décimale) dans les paramètres de configuration régionaux de l‟affichage, les valeur

 suite de plaintes concernant une diminution de la réactivité ou les réactions faussement négatives de certains lots, une enquête a confirmé u
pule Allofit de dimension 50 (catalogue no 4244, lot no 2406181) a pu être emballée sous le nom « cupule Allofit de dimension 52 » (catalogu
et implant avec verrou de sûreté universel de 3,5 mm (no 00 4836 090 00), l‟illustration de la canule percutanée de 1,6 mm comporte une er
 ) ont pu se produire.
de modifier les propriétés de la structure – couleur, rendu de l‟image – dans Focal peut avoir les répercussions suivantes : 1) le collimateur m
nt susceptibles de modifier la barrière de stérilité de l‟emballage et de présenter ainsi un risque accru d‟infection chez le patient.
du chauffe-eau rouille, ce qui occasionne une obstruction prématurée dans le filtre en ligne de 0,2 micromètre et un dysfonctionnement de la

dispositifs, ce qui peut entraîner une interprétation erronée des positions de l‟électroencéphalographe.
se. / Une bavure (semblable à un ruban, un matériau résiduel de métal) a été détectée pendant le contrôle d‟un lot du produit en cours de fab
 Certains lots présentent une séparation moins marquée du coude à 90 degrés qui permet le raccord au bec verseur. Une séparation peut se
  tation des données sur les interférences lors d'hémolyse ou avec les triglycérides et les héparines fractionnes.
 roissant de fuites touche certains lots. Si une fuite se produit, celle-ci peut provoquer un écoulement du médicament, une contamination du
  / La phénytoïne pour épreuve biochimique ne respecte pas les conditions de la stabilité d‟utilisation de 28 jours et l‟étalonnage de 14 jours a
 atient. / Si le capuchon de la pile n‟est pas complètement resserré ou s‟il est endommagé, la pompe peut être mise hors circuit et émettre un
 ml. / L‟utilisation du calibrateur de microalbumine lot 7HD049 conduit à des calibrations non satisfaisantes et à des résultats de contrôle de q
ande variabilité inattendue des résultats, généralement mise en évidence par des valeurs des contrôles N et P se situant en dehors des limite
suite de l‟examen des plaintes retournées concernant des taches de silicone visibles sur le sachet ou le matériau d‟operculage Tyvek, on a id
   de données tridimensionnelles obtenues à partir d‟images de projection autres que la tête d‟abord en position couchée. Les coupes généré
ccouchement, ce qui entraînera une perte de puissance de l‟aspiration.
 t no ID098 de Capture-R Ready-ID comporte une erreur pour le typage N2397 du patient. Le typage N2397 du patient devrait indiquer F+ (F
ci se remettait en marche seulement 30 minutes après l‟autotest.
nstaté que deux paramètres dérivés, ajoutés à la dernière version du logiciel (v. 1.10), ont été calculés à partir d‟équations erronées. Il s‟agis
  société Encore Medical a constaté que deux unités non brevetées (no 400-01-290 au catalogue) ont été implantées. D‟autres unités non bre
 oins peut être transférée sur une lame où sera déposé l‟échantillon d‟un patient ultérieur
décongélation des flacons est plus courte que prévue par les tests de stabilité accélérée et Bio-Rad ne rapporte plus les valeurs de la T3 libr
Les nombres apparaissant dans les champs d‟enregistrement des pages imprimées de la languette enregistrée semblent différer de ceux qu
e une erreur de concordance. Une anomalie mécanique du support provoque sa progression vers la 3e position au lieu de la 1er, produisant
OXimeter 1000E ait été envoyés aux clients avec la fonction « diagnostique » activée, ce qui est susceptible de provoquer l‟affichage de résu
   erreur « Seringue d‟évacuation Toomey de Perfektum » au lieu de « Seringue hypodermique interchangeable de Popper ».
 isation en utilisant le plateau C1160, il est possible que le processeur du SYSTEM 1 ne parvienne pas à s‟arrêter, même si la pompe haute
   Une défaillance du logiciel O-Arm Imaging System, version 3.0, occasionne une erreur d‟affichage de la position des instruments chirurgica
 stent. / Les tomodensitomètres de la gamme PQ (Picker) fournissent de l‟information au logiciel de planification de radiothérapie Pinnacle3 a
  l be incorrect. / Lorsque l‟opérateur utilise les fonctions de mesure linéaire ou de surface sur des images agrandies et archivées, depuis l‟ap

 entiel que le mécanisme de verrouillage se relâche par inadvertance. Si la botte à traction se déloge au cours d‟une interaction à un membre
nsion afin d‟augmenter la protection et de sensibiliser à la présence du bloc d‟alimentation électrique.
n contradiction avec les spécifications du produit. On a observé certains cas de carbonisation et de coagulum.
dged. / Certaines commandes et (ou) interventions n‟apparaissent pas toujours sur la liste de travail du système, comme elles le devraient. T
 a pas été analysée avant la remise en fabrication des produits en stock. Les tests réalisés en vue de démontrer l‟adéquation entre la stérilisa
 genation. / À cause d‟un problème de moulage d‟une composante, le dispositif peut ne pas fournir la concentration d‟oxygène et (ou) le débi
ue le contrôle est analysé avec l'appareil immulyte de siemens.
 ) de dépistage du virus varicelle-zona (VZV).
 ed. / À cause de l‟absence de la goupille de la charnière de porte, il peut y avoir un engagement incomplet ou nul des bras radiaux dans les
 irritations de la peau. Au Canada, 4 rapports indiquent que lors du retrait du timbre, de la peau a été arrachée.
 produit a entraîné des réactions faussement positives lors d‟épreuves sur des spécimens négatifs et le témoin négatif. Ces résultats faux-po
 se causé par l‟irradiation aux rayons gamma dans l‟air des composants en polyéthylène. Ce rappel fait suite à la mise en garde émise par S
  alarm. / La polarité des condensateurs situés sur la carte mère peut être inversée. Les moniteurs touchés peuvent s‟éteindre sans émettre d
 dant l‟administration d‟un traitement séquentiel automatisé.
 suite d‟une erreur de fabrication d‟une composante du moteur, le fonctionnement du moteur de certaines pompes peut être touché et provoq
ant. / L‟article n°122 242, un foret pour élargir de 4,4 mm de diamètre, a remplacé par erreur l‟article n°122 237, un foret pour élargir de 3,9 m
  l‟utilisateur à modifier involontairement un groupe de fractions verrouillé lorsqu‟il utilise la fonction « beam edit » pour modifier un faisceau d
   iViewGTR.3.4.
 ps. / Les pompes à perfusion Sigma 8000/8002 ne sont pas compatibles avec la nouvelle pince à roulettes Hospira Cair reconfigurée. Les cl
a droite) une fois que le soignant a relâché le bouton gauche (ou droit) de la télécommande à infrarouge.

ccessoire (une cale de 60 degrés) a glissé en dehors de l‟interface du porte-accessoire et est tombé au sol pendant le déplacement du supp
 t que les deux lots nommés ci-dessus pouvaient présenter une erreur au niveau de l‟étiquetage du cathéter de remplissage. Le nom comple
d. / Une défaillance du code de logiciel a été découverte dans le Ximavision / Ximatron digital imaging v7.5.51.6 sp2. Ce problème touche un

 / Le prolongateur de la clé à cliquet ne tient pas bien en place dans la clé à cliquet. Les joints toriques utilisés avec le prolongateur ne perme


lectronique
sur
une
carte
de
circuits
imprimés
interne.
un
risque
de
fuite
lorsque
le
protecteur
et
(ou)
l’injecteur
PhaSeal
sont
utilisés
avec
une
fiole
de
médicament
munie
d’un
bouchon
de
cao
ne
limitation
dans
les
versions
2.X,
3.X
et
4.X
du
logiciel
Petsyngo.
Les
données
d’une
TEP
peuvent
être
sauvegardées
chez
le
mauvais
patie
a
découvert
que
des
circuits
de
remplacement
expédiés
à
la
suite
d’un
rappel
effectué
en
juin
2007
avaient
été
mal
emballés,
ce
qui
les
a

on
:
15
août
2006),
identifiée
sur
l’antigramme
comme
ayant
un
antigène
de
type
(A+),
est
plutôt
de
type
(A-).

s
positif
d’environ
0,1
unité
de
pH
sur
l’analyseur
Nova
8
peut
entraîner
des
valeurs
de
rétablissement
normalisées
du
calcium
et
du
magn
 zer.
/
À
la
suite
de
plaintes
qu’il
a
reçues,
le
fabricant
a
décelé
plusieurs
problèmes
relatifs
au
logiciel.
Ces
problèmes
ne
sont
pas
suscepti
ep
10
ne
supportent
pas
le
niveau
de
pression
demandé
lorsqu’elles
sont
utilisées
dans
certaines
conditions.
érogroupe
Y
s’il
est
utilisé
de
façon
incorrecte
et
non
conforme
aux
directives
figurant
sur
la
notice
d’emballage.
aires ne se ferment pas correctement sur les tubes, ce qui entraîne un risque de fuites.
ntenu
du
flacon
peut
se
solidifier
et
il
ne
peut
pas
être
appliqué.
Il
n’y
a
pas
de
risque
pour
la
santé
puisqu’une
fois
que
le
produit
est
solidi
e
de
fuite
a
été
observé
lorsque
le
protecteur
et
l’injecteur
Phaseal
sont
utilisés
avec
des
flacons
fermés
par
un
bouchon
de
caoutchouc
ép

 Informer
les
utilisateurs
qu’une
erreur
d’emplacement
des
mâchoires
X
et
(ou)
Y
peut
se
produire
si
le
verrouillage
n°
51
de
la
position
du
ocution
en
cas
de
contact
avec
le
filament
du
bloc
d’alimentation
Klystron
.
days. 
/

Informer
les
clients
que
l’activation
simultanée
des
touches
de
commande
manuelle
de
la
collision
et
du
mouvement
peut
entraîn
 
 Augmentation
du
nombre
de
plaintes
confirmées
au
sujet
de
la
séparation
complète
ou
partielle
du
tube
et
de
la
connexion
Luer
Lock
de
       Des
plaintes
ont
été
reçues
concernant
des
valeurs
de
troponine
faussement
élevées
obtenues
par
ces
essais.
Ces
résultats
faussem
 ys. 
/

nformité
des
normes
CEI
et
corrige
plusieurs
autres
problèmes.

 va
est
relié
à
un
système
de
gestion
des
données
de
laboratoire,
certaines
conditions
d’erreur
peuvent
entraîner
un
retard
du
signalement
mois
d’août
2007,
la
société
Philips
a
été
informée
que
deux
appareils
Pagewriter
(version
C)
récemment
commercialisés
fournissaient
de
l
 concernant
la
quantité
de
plasma
qui
demeure
dans
les
ensembles
après
la
réinjection
et
le
transfert
du
produit.
Cette
information
sera
a
ppear blank. 
/
 Les
lecteurs
distribués
entre
les
mois
de
mai
et
d’août
2007
peuvent
présenter
des
problèmes
d’affichage
lorsqu’ils
tomben
       Une
modification
du
rappel
précédent
au
sujet
d’une
erreur
d’étiquetage
de
la
pochette
des
produits
finis
a
donnée
lieu
à
l'omission
 de. 
/

associated rods. 
/
  Les
vis
incluses
dans
les
ensembles
d’implants
de
type
S40
fabriqués
avant
le
1er
janvier
2006
peuvent
se
détacher
pen
                                                                                                                                ̊
ossible que les fils-guides conditionnés dans les trousses mises en cause se positionnent de manière incorrecte dans la gaine de mise en pl
 e ne respectent pas les spécifications de la durée de conservation (12 mois) et de la température de conservation (de 2 à 8 C).
a Sensible varient selon que le test est effectué avec des échantillons prélevés dans du sérum ou dans du plasma.
  ont été signalés dans certaines conditions d‟utilisation. La pompe émet un signal sonore et un avis visuel d‟alerte. Le code correspondant a
es de certains lots ne soient pas étanches. Ces canules équipent deux dispositifs distribués au Canada.
 e. / Il est possible que les collimateurs se mettent en mouvement en présence de faisceaux segmentés, par exemple lors d‟une radiothérapi
eur à glissière défectueux dans le bras du détecteur du dispositif Elekta Synergy XVI risque de se traduire par un positionnement incorrect du
mettre la capacité de lavage de l‟appareil pendant son fonctionnement.
nt après l‟étalonnage risquent d‟augmenter la variance des dosages réalisés à l‟aide de dispositifs Unicel DXL 800 dont les paramètres sonor
ent inférieures à la limite inférieure de la fourchette de valeurs prévues.
 re à 8 %, tel qu‟indiqué.

 ccur. / Si un patient est surveillé avec l‟analyse ST désactivée et qu‟une alarme permanente de type « Message » ou de type « Appel » est d
 n raison d‟une erreur de transcription, une valeur d‟étalonnage du C02 a été programmée incorrectement dans le code à barres de la trouss

 it la durée d‟utilisation du dispositif.


ectre Doppler à onde pulsée affichant un angle de correction différent de 0 est rechargé à partir des archives ou envoyé via DICOM, le systè
 lorsque le dispositif est utilisé avec certains médicaments et certains sacs pour perfusion.
ion volontaire de la distribution en raison de la fissuration possible des sondes. Les médecins ne doivent plus implanter ces dispositifs. Les
delivered. / Lorsque les paramètres d‟injection sont programmés simultanément sur la console principale et la console auxiliaire, la désynchr

s de l‟étalonneur du dispositif de chimie clinique ICTMD, certains produisent des courbes de potassium basses mais acceptables qui échoue
 mposant cotyloïdien Durom de taille 54 (no de catalogue 01.00214.054, lot no 2380677) soit emballé avec le composant cotyloïdien Durom
vements de liquide céphalo-rachidien néonatal avec le test au latex par le réactif Neisseria meningitidis B/E. coli K1 de Wellcogen®.
/ La société BD a déterminé que si la fonction « annuler » est utilisée pour annuler la suppression de la fonction « gate », les résultats statis
correct). / Le fabricant a identifié trois problèmes : la température de surface peut dépasser la limite établie, le TI (index thermique) affiche de
eut entraîner un verrouillage du panneau de commande dans le Aplio XG, numéro de modèle SSA-790A.
 rt », et la pompe ne s‟active pas.
 ues à l‟intérieur d‟un même ensemble de réactifs.



 ches peuvent entraîner une diminution du contrôle de qualité ou des résultats des patients, augmenter l‟imprécision et produire l‟erreur no 1
aspiration Frazier et Poole a été affaiblie. Ceci est une prolongation du rappel initié en octobre 2006.
dans certaines circonstances, pourraient associer des résultats au mauvais patient, contaminer un échantillon ou retarder les résultats.
 rrect. / Les couronnes pour molaire permanentes en acier inoxydable de Unitek (900321) ont été emballées et mal étiquetées, à savoir comm
pour ces dispositifs par mesure de précaution car la stérilité de l‟emballage du produit pourrait être affaiblie au niveau du plateau extérieur et
  elease. / Cette mise à jour rectifie un problème au niveau de la logique du contrôleur de mouvement de la table du patient, exécute les restr
 atalogue 00-5755-016-02) peuvent être étiquetés et emballés comme des articles de taille “G” (no de catalogue 00-5755-017-02, lot no 606
 entre le 10 et le 12 octobre contiennent des particules provenant d‟un fournisseur de sacs de plastique.
 r. / L‟applicateur variable d‟électrons numérique (Digital electron variable applicator, DEVA) est conforme à IEC60601-2-1, sauf en ce qui con
  Un certain nombre de plaintes ont été reçues concernant des résultats faussement positifs pour le lot no 97266. Une évaluation a été effect
es numéros 240 et 242 de supports à tubes de trachéotomie bleus de Dale se brisent suite à une modification du produit effectuée par le clie
en garde sur l‟innocuité aux sites potentiellement aux prises avec un problème de sûreté de l‟affichage des images du portail utilisées pour la
  mbre d‟appareils pourraient être sujets à une séparation des connexions internes (la connexion par fils pourrait se rompre) entre le circuit él

ne supportent pas le niveau de pression demandé lorsqu'elles sont utilisées dans certaines conditions.
n event. / En utilisant certains types de capteurs jetables, un niveau de saturation de SpO2 de 100 % peut s‟afficher même si le capteur n‟es
a société Hill-Rom a découvert que le blocage des rails latéraux de certains lits Versacare était défectueux, ce qui peut causer des blessures
 cartouches i-STAT ont des boutons-pression difficiles à fermer, qui ne ferment pas ou qui ne restent pas fermés. Cela peut exposer l‟utilisa

s utilisant une combinaison du système d‟exploitation OSX Multiset version 2.1 avec une version plus récente.

yse d‟aorte peut être surévaluée. L‟utilisation de cette mesure erronée pourrait entraîner le choix d‟une prothèse endovasculaire (stent-graft)
 es supports pour la rétr