Archiv

Archiv Rückrufe Medizinprodukte

Rückrufe und andere Sicherheitsmassnahmen (FSCA) – Archiv
Datum Hersteller Handelsname Produktbeschreibung Informationen Referenz Nr. Swissmedic
27.12.2010 Stryker Leibinger GmbH+Co KG

Stryker Navigation
Model see letter
Software Version: see letter

MD: Robotic surgical navigation system

English1

English2

English3

Vk_20101221_04
27.12.2010 St. Jude Medical

Libra
Model 6608
S/N: all

 

Libra XP
Model 6644
S/N: all

AIMD: Brain electrical stimulation system, antitremor

Deutsch

Français

Italiano

Vk_20101221_05
27.12.2010 Beckman Coulter Inc.

UniCel DxC Clinical Systems

IVD: Expired gas sample collector

Deutsch

Français

English

Vk_20101223_04
27.12.2010 Beckman Coulter Inc.

UniCel DxC and Synchron LX Clinical Systems
Model 600/600PRO/600i/800/800PRO/880i/660i/680i/860i, LX20/LX20PRO/LXi 725

IVD: Clinical chemistry analyser

Deutsch

Français

Vk_20101223_09
27.12.2010 Beckman Coulter Inc.

SYNCHRON System Immunoglobulin A (Ig-A) Reagent
Model Partnumber: 467920
Lot: M808240, M810152; M904324, M909608

IVD: Immunoglobulin A kit

Deutsch

Français

English

Vk_20101223_16
27.12.2010 St. Jude Medical

Riata Lead Riata ST
Model 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592, 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042
S/N: all
Lot: all

AIMD: Implantable defibrillator lead

English

Deutsch

Français

Italiano

Vk_20101223_10
27.12.2010 Sunrise Medical GmbH

Delphin
Model 300900000

MD: Wheelchair

Deutsch

Vk_20100831_03
20.12.2010 Advanced Bionics Corporationy

Update

HiRes 90K
Model Cl-1400-01, Cl-1400-02H
S/N: see letter

AIMD: Cochlear implant system

Deutsch

Français

English

Vk_20101129_03
20.12.2010 CareFusion Switzerland 317 Sàrl

Alaris Syringe Pumps
All Models (CC, GH, GS, PK, TIVA)

MD: Syringe pump

Deutsch

Français

Italiano

English

Vk_20101130_08
20.12.2010 Beckman Coulter Inc.

DHEA RIA Reagent
Model DSL-8900
Lot: see letter

IVD: Radioimmunoassay, dehydroepiandrosterone (free and sulfate)

Deutsch

Français

English

Vk_20101216_04
20.12.2010 Stryker Medical Kalamazoo

5190 TPS Burs
Model see letter
Lot: see letter

MD: Orthopaedic bur, reusable

English

Vk_20101214_04
20.12.2010 Intuitive Surgical

EndoWrist Stabilizer
Model 420182-06, 420182-07, 4210182-T, 420182-E
S/N: Refer to FSN
Lot: refer to FSN

MD: Endotherapy electrosurgical diathermy system electrode, reusable

Français

English

Vk_20101215_06
20.12.2010 Akkuplanet GmbH

AKKUmed NiMH Akku, 3,6 Volt 0.7 Ah
Model 110901-AN
Lot: LOT 1050-01- bis LOT 5260-01

 

AKKUmed NiMH Akku, 2,4 Volt 0,7 Ah
Model 110900-AN
Lot: LOT 1050-01- bis LOT 5260-01

MD: Medical device battery

Deutsch

English

Vk_20101214_06
20.12.2010 Terumo Cardiovascular Systems

CDI 500 Blood Parameter Monitoring System
Model 500AVHCT, 500AHCT, 500AV, 500A
S/N: 1000-4371

MD: Cardiopulmonary bypass system blood gas monitor, in-line

Deutsch

Français

English

Vk_20101215_02
20.12.2010 Medtron AG

ES 224 Patient Line
Model 318081, 318101, 348151
Lot: V015109 (partly), V018118, V015110,V018119, V018112, V022103, V026112

MD: Angiography kit

Deutsch

Vk_20101214_07
20.12.2010 Caridian BCT, Inc.

Spectra Optia Apheresis System
Model 61000
S/N: 1P00100 - 1P0719

MD: Apheresis system

Deutsch

Italiano

English

Vk_20101216_01
20.12.2010 Bausch & Lomb Inc.

ReNu Multi-Purpose Solution
Lot: See list

MD: Contact lens solution

Deutsch

Français

Italiano

English

Vk_20101214_08
20.12.2010 DePuy MITEK Inc.

Intermediary tubing
Model 281102 and 281142
S/N: see attached customer notification

MD: Surgical irrigation tubing set, general-purpose

Deutsch

Vk_20101214_10
20.12.2010 bioMérieux Inc.

BacT/ALERT SA, SN, FA, FN, PF, MB
Model 259789, 259790, 259791, 259793, 259794, 251011

IVD: Culture medium, non-selective/non-differential

Deutsch

Français

English

Vk_20101215_04
20.12.2010 Inverness Medical Japan Co. Ltd

Determine HIV-1/2 Ag/Ab Combo
Model 7D2646, 7D2647
Lot: 100504

IVD: Human immunodeficiency virus 1/2 rapid test device

Deutsch

Françqais

English

Vk_20101214_09
20.12.2010 Terumo Cardiovascular Systems

CDI 100 and 101 Hematocrit/Oxygen Saturation Monitoring System
Model 100, 101
S/N: Model 100: 100-001 to 100-1687; Model 101: 1070 to 1697

MD: Cardiopulmonary bypass system blood gas monitor, in-line

Deutsch

English

Vk_20101215_01
13.12.2010 MACHEREY-NAGEL GmbH & Co. KG

Medi-Test Combi 9
Lot: 32928

IVD: Urine rapid test device, multiple-constituent

Deutsch

Vk_20101207_08
13.12.2010 GE Hangwei Medical Systems Co., Ltd

All GE MR Cylindrical systems

MD: Magnetic resonance imaging system

Deutsch

Français

Italiano

Vk_20101208_03
13.12.2010 Abbott Point of Care

i-STAT Celite ACT cartridge
Model 07G01-0l, 07G01-02, 03P86-25, 600-9006-25

IVD: Activated whole blood clotting time kit

English

Vk_20101207_15
13.12.2010 AngioScore Inc.

AngioSculpt PTA Scoring Ballon Catheter
Model see letter
S/N: see letter

MD: Angioplasty catheter

Deutsch

Français

Italiano

Vk_20101207_03
13.12.2010 GE Hangwei Medical Systems Co., Ltd

GE Medical Systems LLC

GE Healthcare Japan Corporation

MRI System
Model all
S/N: see letter
Lot: see letter

MD: Magnetic resonance imaging system

Deutsch

Français

Italiano

Vk_20101207_01
13.12.2010 UROMED Kurt Drews GmbH

Uromed Soft Silikon-Ballon-Katheter
Model REF 1095 & REF 1148
Lot: Various

MD: Urethral catheter, drainage, indwelling, standard

Deutsch

English

Vk_20101203_03
13.12.2010 GE Medical Systems LLC

GE Hangwei Medical Systems Co., Ltd

GE Healthcare Japan Corporation

MRI System
Model Signa, Infinity, Optima, Brivo
S/N: see letter
Lot: see letter

MD: Magnetic resonance imaging system

Deutsch

Français

Italiano

Vk_20101207_02
13.12.2010 Siemens Healthcare Diagnostics Products Limited

Immulite/lmmulite 1000/2000 & 2500 LBP and LBP Control Module
Model LKLB, L2KLB, L5KLB, LLBCM
Lot: LKLB: 304 and below, L2KLB: 208 and below, L5KLB: 157 and below, LLBCM: 040 and below

IVD: Lipopolysaccharide binding protein (LBP) kit and controls

Deutsch

English

Vk_20101207_17
13.12.2010 BrainLAB AG

KOLIBRI Navigation Station 2.0 (with mobile camera stand 2.0)
Model 19506C
S/N: See List

MD: Robotic surgical navigation system

Deutsch

English

Vk_20101208_04
06.12.2010 Accuray Inc.

CyberKnife Robotic Radiosurgery System

MD: Linear accelerator system

Deutsch

Vk_20101202_04
06.12.2010 Unomedical A/S

Unomedical Sterile Urine Drainage Bag
Model See list

MD: Urine collection bag

Deutsch

English

Vk_20101203_01
06.12.2010 Roche Diagnostics Ltd

cobas u 411
Model 04906969001
Software Version: 3.1.0.0901, 3.0.4.0801

IVD: Laboratory urine analyser IVD, automated

Deutsch

Français

English

Vk_20101130_01
06.12.2010 GE Healthcare

GE Centricity PACS IW
Software Version: 2.1.x, 3.0.x and 3.1.x

MD: Picture archiving and communication system, radiology

Deutsch

Français

Vk_20101130_11
06.12.2010 Thermo Fisher Scientific Microbiology Basingstoke

Salmonella Selective Supplement
Model SR0194E
Lot: 936625

IVD: Culture medium supplement, enriched

English

Vk_20101201_07
06.12.2010 Beckman Coulter Inc.

SYNCHRON Systems Glucose (GLU) Cartridge Reagent For Use on UniCel and SYNCHRON Systems
Model 442640
Lot: all

IVD: Glucose kit

Deutsch

Français

English

Vk_20101201_01
06.12.2010 Medtronic Ablation Frontiers LLC

GENius Multi-Channel RF generator
Model 990018
S/N: 09163054, 09163121, 07128059, 09163054, 2010004161
Software Version: All current versions of the GENius Multi-Channel RF generator

MD: Cardiac tissue ablation system

Deutsch

Français

Vk_20101130_09
06.12.2010 Stanmore Implants Worldwide Limited

METS Modular Tumour System
Model Mkrhm/SmSt
S/N: A7203

MD: Implant, Stem

English

Vk_20101201_02
06.12.2010 Vital Images Inc.

VitalConnect, Vitrea Enterprise Suite (VES)

MD: Basic diagnostic x-ray system application software

Deutsch1

Français1

English1

Vk_20101202_02
06.12.2010 Merit Medical Systems, Inc.

Valved One-Step Centesis Drainage Catheter
Model OSC
Lot: see letter

MD: Catheter

Deutsch

Français

English

Vk_20101201_03
06.12.2010 Beckman Coulter Inc.

Access Total Beta-hCG Assay
Model 33500
Lot: all

IVD: Beta-human chorionic gonadotropin kit

Deutsch

Français

English

Vk_20101201_04
06.12.2010 Nestlé Healthcare Nutrition GmbH

COMPAT Go Pump
Model 12062342
S/N: All pumps with serial Number between 19325926 and 20737393
Software Version: All bellow 5.1j

MD: Enteral feeding pump

Deutsch

Français

Italiano

Vk_20101116_04
06.12.2010 Stryker Orthopaedics Mahwah

Straight Cuting Edge Advantage Rasp Handle
Model 1100-1000
S/N: all
Lot: all

 

Custom Rasp Handle
Model I-H0889HF00, I-H1389HF00

 

Accolade Rasp Handle
Model 1440-1400
S/N: all

MD: Orthopaedic prosthesis implantation instrument

Deutsch

Italiano

Vk_20101125_03
06.12.2010 Coloplast A/S

Prostaflow, Prostatectomy catheter
Model AB7018, AB7020,AB7022, AB7024AB7218, AB7220, AB7222, AB7224AB7520, AB7522AB7620AB7718, AB7720,AB7722,AB7724AB7818, AB7820,AB7822,AB7824AB7922AB7A20, AB7A22AB7C18, AB7C22AB7E18 -AB7K22
S/N: see list
Lot: see list

MD: Urethral catheter, drainage, indwelling, standard

Deutsch

Français

Italiano

English

Vk_20101202_03
06.12.2010 Roche Diagnostics GmbH

cobas c311. c501/c502; Roche/Hitachi 912, 917, MODULAR ANALYTICS P; cobas Integra 400/400 plus 800

 

Acetaminophen
Model 20767174322, 03255379190

IVD: Clinical chemistry analyser; Acetaminophene kit

cobas c (Deutsch)

cobas c (Français)

Hitachi, MODULAR (Deutsch)

Hitachi, MODULAR (Français)

cobas Integra (Deutsch)

cobas Integra (Français)

Vk_20101124_20
29.11.2010 Beckman Coulter Inc.

Update

UniCel DxC 600, UniCel DxC 600 PRO, UniCel DxC 600i, UniCel DxC 680i, UniCel DxC 660i
S/N: all

 

UniCel DxC 800, UniCel DxC 800 PRO, UniCel DxC 880i, UniCel DxC 860i
S/N: all

IVD: Clinical chemistry analyzer for special purpose

Deutsch

Update Deutsch

Français

Update Français

English

Update English

Vk_20100126_12
29.11.2010 Siemens Healthcare Diagnostics Products GmbH

BCS System
Model OVIO032

IVD: Haematology analyser, coagulation

Deutsch

Français

English

Vk_20101124_07
29.11.2010 GE Medical Systems

Transport Pro
S/N: see letter
Software Version: all

MD: Patient monitoring system, general physiology, single-patient

Deutsch

Français

Vk_20101124_01
29.11.2010 Innogenetics NV

INNOTEST hTau Ag
Model 80323
Lot: 212537

IVD: human tau antigen

Deutsch

Français

English

Vk_20101125_06
29.11.2010 Biomet Orthopaedics Switzerland GmbH

Refobacin Bone Cement, Refobacin Plus Bone Cement, Refobacin Revision
Model See letter
Lot: See letter

 

Biomet Bone Cement, Biomet Plus Bone Cement
Model See letter
Lot: See letter

MD: Cement, bone

Deutsch

English

Vk_20101124_09
29.11.2010 Roche Diagnostics GmbH

Accu-Chek Inform
Model 03035123001, 03035123971

IVD: Glucose rapid test system analyser

Deutsch

Français

English

Vk_20101124_19
29.11.2010 Welch Allyn Inc

Pressure Infusion Cuff
Model 51-08-040 / 51-08-040DS
Lot: 100999, 101024, 101037, 101048, 101082, 101084, 101117,101119, 101126, 101199

MD: Pressure infusor, manual

English

Vk_20101124_06
22.11.2010 Siemens Healthcare Diagnostics Inc.

Dimension Vista Free Prostate Specific Antigen
Model K6452

 

Dimension Vista Total Prostate Specific Antigen
Model K6451

 

Dimension Vista PSA Calibrator
Model KC602

IVD: Free (unbound) prostate specific antigen (PSA) IVD, reagent; Total prostate specific antigen (PSA) IVD, reagent; Multicomponent clinical chemistry calibrator

Français

English

Vk_20101117_15
22.11.2010 Siemens Healthcare Diagnostics Inc.

Dimension Vista Gentamicin (GENT) Flex reagent cartridge
Model K4012
Lot: all

IVD: Gentamicin kit

Deutsch

Français

English

Vk_20101117_09
22.11.2010 TomoTherapy Inc.

TOMO Hi-Art System
Model TomoDirect

MD: Linear accelerator system

Deutsch

Français

Italiano

English

Vk_20101117_17
22.11.2010 Ulrich Medical GmbH & Co.KG

CO2 Insuflator / CO2 Flow
S/N: 10.890191
Software Version: 1.5

MD: Hysteroscopic gas distention system

Deutsch

Vk_20101109_08
22.11.2010 LUMEN BIOMEDICAL, Inc.; Volcano Corporation

Lumen Xtract Aspiration Catheter
Model 1451-001 Groesse und 4.2f 1451-003 Groesse 5.8F

MD: Embolectomy/thrombectomy catheter

Deutsch

Vk_20101116_06
22.11.2010 GE Healthcare

GE Centricity PACS IW
Software Version: 3.7.1 and above

MD: Picture archiving and communication system, radiology

Deutsch

Français

Vk_20101116_03
22.11.2010 Philips Medical Systems

IntelliVue Information Center
Model see letter
S/N: see letter

MD: Patient monitoring system central unit

Deutsch

English

Français

Italiano

Vk_20101117_01
22.11.2010 Aesculap AG & Co. KG

Microspeed Uni Steuereinheit mit Kühleinheit
Model GD670
S/N: all

 

Microspeed Arthro Steuereinheit
Model GD665
S/N: all

MD: Remotely-driven surgical drilling system motor

English

Vk_20101117_04
22.11.2010 Heraeus Kulzer GmbH

SOPIRA Carpule Needle Free Flow
Model 27G, 04x38mm
S/N: see letter
Lot: see letter

 

SOPIRA Carpule Needle
Model 27G, 04x38mm; 27G, 04x35mm
S/N: see letter
Lot: see letter

MD: Cannulae, Other

Deutsch

Vk_20101027_06
22.11.2010 Varian BrachyTherapy

BrachyVision
Software Version: 8.2, 8.5, 8.6, 8.8, 8.9

MD: Brachytherapy system application software

Deutsch

Français

Italiano

English

Vk_20101105_01
22.11.2010 Zimmer, Inc.

Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter
Model 00-2490-003-50
Lot: 00111903; 07890923

MD: Orthopaedic prosthesis implantation instrument

Deutsch

English

Vk_20101116_01
22.11.2010 Radiometer Medical ApS

ABL90 FLEX
Model 393-090
S/N: all
Software Version: 2.4.1680.5; 2.4.1680.6; 2.4.1680.21

IVD: Blood gas/pH/electrolyte/metabolite analyser

English

Vk_20101116_05
22.11.2010 Philips Medical Systems

IntelliVue Clinical Information Portfolio (ICIP)
Model 865047
S/N: see letter
Software Version: Software D.00 bis D.03

MD: Data management system, patient

Deutsch

English

Vk_20101116_02
22.11.2010 Ossur Head Office

Resolve Halo Vest
Model 545700K, 545700L, 545800K, 545800L

MD: Stabilization System for cervical spine

English

Vk_20101118_01
15.11.2010 Scient'x

TeCorp implants Borrows 13mm (Fuchsia)
Model 11ICC13-20; 11ICC13-26; 11ICC13-38
Lot: all

MD: corpectomy implants

English

Vk_20101102_09
15.11.2010 Otto Bock Health Care GmbH / Otto Bock Mobility Solutions GmbH

Skippi power wheelchair
Model 490ESS

MD: Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, collapsible

Deutsch

Vk_20100908_05
15.11.2010 Smiths Medical ASD, Inc.

D-60HL and DI-60HL Normothermic I.V. Fluid Administration Sets
Model D-60HL, DI-60HL
S/N: See list
Lot: See list

MD: Intravenous administration set, heat-exchanging

Deutsch

Français

English

Vk_20101014_04
15.11.2010 Leica Biosystems Newcastle Ltd

Bond Polymer Refine Detection
Model DS9800
Lot: 10818,10926,10935,11279,11297,11315,11485, 11604,11693,11967

IVD: IVD for immunohistochemical staining

Deutsch

English

Français

Vk_20101109_14
15.11.2010 Becton Dickinson and Company

BD 5ml Plastipak Syringe Luer-Lok Tip
Model 300911
Lot: 10E05F

MD: Sterile injection syringe, general use

Deutsch

Français

Vk_20101110_02
15.11.2010 Gambro Industries

UltraSteriSet
Lot: See list

MD: Intravenous line filter

English

Vk_20101111_01
15.11.2010 Beckman Coulter Inc.

Access Immunoassay Systems Thyroglobulin
Model 33860
Lot: all

IVD: Thyroglobulin kit

Deutsch

Français

English

Vk_20101109_20
15.11.2010 Arrow International, Inc.

Arrow arterial line kits
Model see letter

 

Arrow Venous access kits
Model see letter

 

Arrow Single shot epidural kits
Model see letter

MD: Arterial blood pressure catheter; Central venous catheterization kit; Epidural needle

Deutsch

Français

Italiano

English

Vk_20101109_10
15.11.2010 Linet spol. s r.o.

Eleganza 3, Eleganza 3XC
S/N: all

MD: Basic electric hospital bed

English

Vk_20100915_01
15.11.2010 Beckman Coulter Inc.

Access Immunoassay System and Access 2 Immunoassay System (which use an external waste bottle)
S/N: all

 

SYNCHRON LXi 725 Clinical System and UniCel DxC 600i System (which use an external waste bottle)
S/N: all

IVD: Immunoassay analyser

Deutsch

Français

English

Vk_20101109_11
08.11.2010 Beckman Coulter Inc.

Synchron CX Clinical Systems
Model CX4, CX4 Delta, CX4CE, CX5, CX5 Delta, CX5CE, CX7, CX7 Delta, CX9ALX

IVD: Clinical chemistry analyser

Deutsch

Français

English

Vk_20101103_01
08.11.2010 BioMérieux SA

VIDAS HIV DUO Quick
Model 30447
Lot: 841193701, 841193801

IVD: HIV - multiple (1/2)

Deutsch

Français

English

Vk_20101026_02
08.11.2010 Siemens Healthcare Diagnostics Inc.

2. Update

Dimension Vista V-LYTE Standard A
Model K820
Lot: KA0C03, KA0D01, KA0E01, KA0E02, KA0F01, KA0G01, KA0H01 and following lots

IVD: Calibrators and standards (clinical chemistry)

Deutsch

Update Deutsch

2. Update Deutsch

Français

Update Français

2. Update Français

Vk_20100915_05
08.11.2010 Beckman Coulter Inc.

CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5
Model PN 6607013
Lot: All lots since 08/2003

 

CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5
Model PN 6607073
Lot: All lots since 08/2003

IVD: B/T-cell subtyping antibody kit

Deutsch

English

Vk_20101102_12
08.11.2010 Philips Medical Systems

Brilliance EBW
Model 728260, 728269
Software Version: v2.0.5, v2.0.11. v3.0, v3.0.1, v3.0.2, v3.5, v3.5.2, v3.5.3, v3.5.4, v3.5.35, v4.0.1, v4.0.2, v4.0.3, v4.5.1 and Brilliance Workspace Portal v2.5.1.17, v2.5.1.19

MD: Full-body CT system

Deutsch

Français

English

Vk_20101102_11
08.11.2010 BioMérieux SA

VITEK 2 Piperacillin/Tazobactam Test
Model see letter
Lot: all

IVD: Culture medium, antimicrobial susceptibility test

Deutsch

Français

English

Vk_20101102_10
08.11.2010 Terumo Cardiovascular Systems

Sarns Ultrasonic air sensor - Air sensor cable
Model 149892, 78-8067-7375-6
Lot: All lots

MD: Cardiopulmonary bypass system, roller type

Deutsch

English

Vk_20101102_07
08.11.2010 Codman and DePuy Spine

DePuy S-ROM Noiles Distal Femoral Cutting Guide
Model 216311001 and 216311004

MD: Orthopaedic prosthesis implantation instrument

English

Vk_20101105_02
08.11.2010 Philips Medical Systems BV

Allura Xper and Integris
Model see letter

MD: Fluoroscopic x-ray system, general-purpose, stationary, analogue

Deutsch

Français

Italiano

English

Vk_20101102_06
08.11.2010 Micrus Endovascular

Micrus Endovascular Microcoil Delivery System
Model see list
Lot: see list

MD: Embolization implant kit

Deutsch

English

Vk_20101102_02
08.11.2010 Johnson & Johnson AG Medical

Update

1 DAY ACUVUE TruEye
Lot: 4922370104, 4922920101, 4922920102, 4922920301, 4922920401, 4922500109, 4922510101, 4922510103, 4922510104, 4922510107, 4922870109, 4922881204, 4922820708, 4922840102, 4922810600, 4922811102, 4922540101; update: 492237-492498, 502080-502269

MD: Contact lens

Update Deutsch

Update Français

Update Italiano

Update English

Vk_20100826_05
08.11.2010 Beckman Coulter Inc.

UniCel DxH 800 Coulter Cellular Analysis System
S/N: all
Software Version: 1.1.3.0

IVD: Haematological cell analyser IVD, automated

Deutsch

English

Vk_20101104_02
01.11.2010 Gambro Dasco S.p.A.

S-660-C Accessory for haemodialysis
Model 6431233
Lot: 1035-1036-1037

MD: Haemodialysis tubing set, single-use

Deutsch

Vk_20101028_04
01.11.2010 Dräger Medical AG & Co.

NIBP cuffs Neonatal
Model MP00901, MP00902, MP00903, MP00904,MP00905

MD: Blood pressure cuff, single-use

Deutsch

Vk_20101028_05
01.11.2010 Trinity Biotech USA

G-6-PDH Normal Control Kit
Model G6888
Lot: 027, 028, 029

IVD: Enzyme controls (assayed and unassayed)

Deutsch

English

Vk_20101027_03
01.11.2010 Boston Scientific Corporation

Matrix2 Detachable Coil
Model See letter
Lot: See letter

MD: Neurovascular embolization implant

Deutsch

English

Vk_20101028_07
25.10.2010 Medtronic Inc.

Dual-Chamber External Temporary Pulse Generator
Model 5388

MD: External pacemaker, invasive

Deutsch

Vk_20101019_01
25.10.2010 Abbott GmbH & Co. KG

Update

CELL_DYN Analyser
Model 1700, 1700CS, 3200CS, 3200SL, 3500CS, 3500SL

IVD: Haematological cell analyser IVD, automated

English

English2

Vk_20100915_10
25.10.2010 GS Elektromed. Geräte

Corpuls 3 Defibrillator
Model 04000
Software Version: 1.6.0, 1.6.2

MD: Defibrillation/physiologic monitoring system

Deutsch

English

Vk_20101020_07
25.10.2010 Confluent Surgical

PleuraSeal Lung Sealant System
Model PLS-005
Lot: all

MD: Dressing, occlusive/semi-occlusive, hydrogel

Deutsch

Français

Italiano

Vk_20101020_01
25.10.2010 GE / OEC Medical Systems Inc.

OEC 9900 Elite

 

OEC 9800

MD: Fluoroscopic x-ray system, angiography, mobile; Fluoroscopic x-ray system, angiography, stationary, analogue

Deutsch

Vk_20101020_05
25.10.2010 Immucor, Inc.

Panocell-20
Model 0005020
Lot: 35385

IVD: Antibody identification cell panel kit

Deutsch

English

Vk_20101020_14
25.10.2010 Beckman Coulter Inc.

Access/Access 2 Systems (stand-alone) & SYNCHRON Lxi 725 and UniCel DxC 600i integrated Systems
S/N: all
Software Version: all

 

UniCel Dxl Systems (stand-anole) & Unicell DxC 880i, 860i, 680i, 660i integrated Systems
S/N: all
Software Version: all

IVD: Immunoassay analyser

Deutsch1

Deutsch2

Français1

Français2

Vk_20100930_10
25.10.2010 Varian Medical Systems Inc

EXACT couch and EXaCT Targeting couch
Model H14, H18, H27, H29 and H77
S/N: see letter

MD: Linear accelerator system / Simulator, Radiation Therapy

Deutsch

Français

Italiano

English

Vk_20101022_01
18.10.2010 Obtech Medical Sàrl

VelocityTM Injection Port and Applier
Model PT2XV

 

SAGB Quick Close Swedish Adjustable Gastric Band including VelocityTM Injection Port and Applier
Model BD2XV

 

SAGB VC Swedish Adjustable Gastric Band including VelocityTM Injection Port and Applier
Model BD3XV

MD: Prosthesis, internal, band, gastroplasty; Infusion/injection port, implantable

Deutsch

Français

Vk_20101013_05
18.10.2010 Microm International GmbH,Thermo Fisher Scientific

HM 550
Model HM 550
S/N: 36565 - 48685

IVD: General Histology Instruments

Deutsch

Français

Vk_20101012_05
18.10.2010 Siemens Medical Solutions

TxT Table for Siemens Linear Accelerator ARTISTE/ONCOR/PRIMUS
Model 5857912

MD: Linear accelerator system

English

Vk_20101012_03
18.10.2010 Smiths Medical ASD, Inc.

CADD-Legacy Duodopa Pump
Model 1400
S/N: see list
Software Version: 97-0444 Revisions B and C

MD: Infusion pump, ambulatory

English

Vk_20101013_04
18.10.2010 Arrow International INC

IAB-05800 Series IAB with SuperArrowFlex (Wire-reinforced) Sheath
Model IAB-05830-U; IAB-05830-LWS; IAB-05840-U; IAB-05840-LWS

MD: Cardiac catheter, balloon, intra-aortic

Deutsch

Français

Italiano

English

Vk_20101012_02
18.10.2010 Ortho-Clinical Diagnostics Inc.

VITROS 5600
Model 6802413
Software Version: 1.5 and below

 

VITROS 5,1 FS
Model 6801375
Software Version: 2.5 and below

IVD: Clinical chemistry analyser

Deutsch

English

Vk_20101013_09
18.10.2010 Ethicon Endo-Surgery, LLC

Trocar, abdominal / Bladeless trocar, Universal trocar, Dilating tip trocar, Blunt tip trocar, Troca
Model B,CB,D,H,K

MD: Laparoscopic trocar

Deutsch

Français

Italiano

English

Vk_20101013_10
18.10.2010 Siemens Medical Solutions USA Inc.

ACUSON fourSight 4Z1c Transducer
Model 10033682
Lot: All, at or below 025xxxxx

MD: Extracorporeal ultrasound imaging system transducer, hand-held

English

Vk_20101014_02
18.10.2010 Medtronic Inc.

Intrathecal Catheter Kit
Model 8731SC
Lot: see letter

 

Spinal Segment Revision Kit
Model 8598A
Lot: see letter

AIMD: Catheter

Deutsch

Français

Vk_20101012_01
18.10.2010 Beckman Coulter Inc.

Core TDM Multi-Calibrator
Model ODC6411
Lot: 0021, 0022

IVD: Drug calibrator

Français

English

Vk_20101014_03
18.10.2010 Alere San Diego, Inc

Cholestech LDX Lipid Controls, Level 1 & 2
Model 10-982, 10-983
Lot: SV0146, SC0146

 

Cholestech LDX Multi-Analyte Controls, Level 1 & 2
Model 12-712, 12-713
Lot: MV0146, MC0146

 

Cholestech LDX Calibration Verification, Levels 1 - 4
Model 11-255
Lot: 0146

IVD: Assayed multicomponent serum kit, normal

Deutsch

Français

Italiano

English

Vk_20101013_07
18.10.2010 Ortivus AB

MobiMed Clinical Workstation
Model 490136676
Software Version: 3.1

MD: Patient monitoring system

English

Vk_20101013_08
11.10.2010 Elekta CMS Software

XiO
Software Version: 4.0.2 and above

MD: Radiation therapy treatment planning system application software

Deutsch

Français

Italiano

English

Vk_20100812_01
11.10.2010 Roche Diagnostics GmbH

cobas c 701
Model 05171989190
Lot: 627326-01

 

cobas c 111
Model 05171989190
Lot: 626022-01

 

cobas c 311 / 501/502 & Cobas Integra
Model 20763128322
Lot: 626019-01

IVD: Calcium kit

Deutsch

Français

English

Vk_20101006_01
11.10.2010 Siemens Healthcare Diagnostics Products Limited

Immulite 2500 HCG
Model L5KCG2, L5KCG6
Lot: 154, 155, 157

IVD: Total human chorionic gonadotropin kit

Deutsch

Vk_20101007_04
11.10.2010 Axon Lab AG

Axon MC
Model A11A01639, AXON00115, 1 0849
Lot: 9761

IVD: Total bilirubin IVD, reagent

Deutsch

Français

Vk_20100930_03
11.10.2010 Beckman Coulter Inc.

Access Immunoassay Systems Total T4 Calibrators
Model PN 33805
Lot: 917074, 008534

IVD: Thyroxine kit

Deutsch

Français

English

Vk_20101007_01
04.10.2010 IMPAC Medical Systems

SEQUENCER for Multi-Access and MOSAIQ
Software Version: From version 5.00 forward, and all versions/builds of MOSAIQ released to date.

MD: Radiation therapy treatment record/verify system application software

Deutsch

Français

Italiano

English

Vk_20100921_07
04.10.2010 Becton Dickinson Biosciences

CD10 APC
332777
Lot: 75222, 71593

 

CD10 PE
332776
Lot: 73230, 64666, 69354

 

CD10 PE-Cy7
341112
Lot: 76706

 

CD10 FITC
332775
Lot: 73423, 70472

 

BD Oncomark CD5/CD10/CD19
331357
Lot: 71594

IVD: Cell surface receptor recognizing antibody kit

English

Deutsch

Vk_20100921_16
04.10.2010 Miele & Cie. KG

Olympus ETD3 plus
Model ETD3 plus GA (E0425500), ETD3plus PAA (E0425502), ETD3 plus PAA UK (E0425504)

MD: Flexible endoscope washer

English

Deutsch

Français

Vk_20100928_08
04.10.2010 Siemens Medical Solutions USA Inc.

Acuson S2000 with cardiac option
Model 10041461
Software Version: all versions below VB10A

MD: Scanner, ultrasonic, general-purpose

English

Vk_20101001_01
04.10.2010 BrainLAB AG

iPlan Stereotaxy Planning Software 3.0
Model 21210E, 21356, (21242)
Software Version: 3.0.0 or 3.0.1

MD: Robotic surgical navigation system

Deutsch

English

Vk_20100930_02
04.10.2010 Siemens Healthcare Diagnostics Products GmbH

Enzygnost HBsAg 6.0
Model OPFM055, OPFM115
Lot: 39971, 39972

IVD: Hepatitis B virus surface antigen kit

Deutsch

Vk_20100930_09
04.10.2010 AngioDynamics Inc.

Habib 4X Kit Bipolar Resection Device
Model 4401 / 4401L

MD: Device, electrosurgical, cutting & coagulation & accessory

English

Vk_20100929_03
04.10.2010 Bühlmann Laboratories AG

Amanitin ELISA
Model EK-AM1
Lot: 1833.1, 0537.1

IVD: Amanitin kit

English

Vk_20100928_03
04.10.2010 Abbott GmbH & Co. KG

Architect iVancomycin
Model 1P30-25
Lot: All Lots

IVD: Vancomycin kit

Deutsch

English

Vk_20100928_02
04.10.2010 Philips Medical Systems DMC GmbH

Essenta DR Compact
Model 712072

MD: Digital imaging system, computed radiography, general-purpose

Français

English

Vk_20100930_14
04.10.2010 ConMed Corp.

ConMed Pediatric/Neonatal Wire Attached ECG Electrodes
Model see letter
Lot: see letter

MD: Electrocardiograph electrode

English

Vk_20100930_01
04.10.2010 Siemens Medical Solutions USA Inc.

Acuson X300 with cardiac option
Model 10037409, 10132987, 10038837, 10133170, 10348531, 10348532, 10348533
Software Version: 1.0.00 to 1.0.14, 2.0.00 to 2.0.11, 3.0.00 to 3.0.06, 4.0.00 to 4.0.07, 5.0.00 to 5.0.08, 6.0.00 to 6.0.01

MD: Scanner, ultrasonic, general-purpose

English

Vk_20101001_02
04.10.2010 Medtronic Inc.

Octopus Nuvo Tissue Stabilizer
Model TSMICS1
Lot: see letter

MD: Patient positioning vacuum pad

Deutsch

Vk_20100928_06
04.10.2010 Abbott Laboratories

ARCHITECT Tacrolimus reagent
Model 01L77-25
S/N: 86599M500

IVD: Tacrolimus kit

Deutsch

Français

English

Vk_20100930_07
04.10.2010 Siemens Medical Solutions USA Inc.

Acuson Antares with cardiac option
Model 05936518, 08653771, 10037593, 10032747, 10037592, 10032746, 10037591, 10038202, 10040729, 10040728,
Software Version: 4.0 / 5.0

MD: Scanner, ultrasonic, general-purpose

English

Vk_20100930_18
04.10.2010 TomoTherapy Inc.

Update

TOMO Hi-Art System
Model H-000-0003
Software Version: 4.0.0,4.0.1,4.0.2

MD: Linear accelerator system

Deutsch

Français

Italiano

English

Vk_20100629_06
04.10.2010 Philips Medical Systems

IntelliVue Multi Measurement Server X2
Model M3002A, M8102A

MD: Patient monitoring system, general physiology, single-patient, transportable

Deutsch

Français

Italiano

English

Vk_20100930_16
04.10.2010 GE Hangwei Medical Systems Co., GE Yokogawa Medical Systems

BrightSpeed Excel/Edge/Elite Select; BrightSpeed Elite
Software Version: 08BW44.1 distributed from September 2008 to August 2010

MD: Full-body CT system

Deutsch

Vk_20100929_01
04.10.2010 Axon Lab AG

Axon MC
A11A01639, AXON00115, 1 0849
Lot: 9761

IVD: Total bilirubin IVD, reagent

Deutsch

Français

Vk_20100930_03
27.09.2010 Vascular Solutions Inc.

Langston Dual-Lumen Pigtail Catheter
Model 5540
Lot: 548110, 548227, 548364, 548430, 548554, 548723

MD: Angiographic catheter, single-use

English

Vk_20100922_17
27.09.2010 Terumo Cardiovascular Systems

Terumo Advanced Perfusion System 1
Model 801764, 801188

MD: Cardiopulmonary bypass system, roller type

Deutsch

Français

English

Vk_20100922_16
27.09.2010 Kimal Plc.

K-Flow Haemo Product
Model see letter

 

K-Flow Access Catheters
Model see letter

 

K-Flow Right Atrial Product
Model see letter

MD: Haemodialysis catheter, implantable

English

Vk_20100921_06
27.09.2010 GE Healthcare Japan Corporation

Optima CT660
Software Version: 10HW02.10

MD: CT system, full-body

Deutsch

Vk_20100922_09
27.09.2010 Vital Signs Inc.

Enginivity eFlow T Fluid Warmer
S/N: see letter
Lot: see letter

MD: Blood/fluid warmer

Deutsch

Français

Italiano

Vk_20100921_14
27.09.2010 Physio-Control Corporation

Update

External Sterilizable Defibrillation Paddles and Pediatric Paddle attachments
Model PN: 3009166-XX for use with LIFEPAK 12 and 20/20e / PN: 804507-XX for use with LIFEPAK 9 and 9P / PN: 800418-XX Pediatric Paddle attachments
Lot: all

MD: Defibrillator electrode, external, reusable

Update Deutsch

Deutsch

Vk_20081126_15
27.09.2010 TomTec Imaging Systems

Image-Com
Software Version: 4.1, 4.2, 4.3

MD: Ultrasound imaging system software, application program

Deutsch

Vk_20100921_09
27.09.2010 Medtronic Inc.

SynchroMed II programmable pump
Model 8637-20, 8637-40

AIMD: General-purpose implantable infusion pump, programmable

Deutsch

Français

Vk_20100922_20
27.09.2010 AGA Medical Corporation

Amplatzer Cardiac Plug
Model 9-ACP-007-XXX
S/N: All
Lot: All

MD: Cardiac occluder

Deutsch

Français

Italiano

Vk_20100921_05
27.09.2010 Biomet 3i

GOLD SLOT SCREW - 3mm
Model GS300
Lot: 868517, 865348, 868515

MD: Dental implant suprastructure device, permanent

Deutsch

Français

Italiano

English

Vk_20100921_02
27.09.2010 Newdeal SAS

Screwdriver Torx T7
Model 219127
S/N: EHMN

MD: Surgical screwdriver, reusable

English

Vk_20100812_02
27.09.2010 DiaMed GmbH

DiaPlastin-E liquid
Model 310120 / 310104 / 310240 / 310108
Lot: Batches 31120.65 - 31120.67

IVD: Prothrombin time kit

Français

Vk_20100921_01
27.09.2010 Leica Biosystems Melbourne Pty Ltd

Leica Peloris Rapid Tissue Processor
Model Peloris
S/N: 0260018A to 0260312A inclusive

IVD: Tissue processor

Deutsch

Français

Italiano

Vk_20100922_05
20.09.2010 Medtronic Inc.

Intrathecal Catheter
Model 8709, 8709SC, 8703, 8703W, 8731, 8731SC, 8711, 8749, 8598, 8598A

AIMD: Anaesthesia conduction catheter

Deutsch

Français

Italiano

Vk_20100908_09
20.09.2010 BioMérieux SA

TPHA 100
Model 72492
Lot: 1001102325

IVD: Syphilis-treponemal total antibody kit

Deutsch

Français

Vk_20100915_03
20.09.2010 GE Medical Systems Information

Aisys carestation
Lot: ANAH00100 bis ANAP00727

 

Avance S/5 Anaesthesia System
Lot: ANBG00100 bis ANBP01176

 

Amingo Carestation
Lot: AMNM00101 bis AMNP00112

MD: Anaesthesia workstation, general-purpose

Deutsch

Français

Vk_20100914_08
20.09.2010 CMS Inc.

XiO
Model see letter
S/N: see letter

MD: Radiation therapy treatment planning system software, application program

English

Vk_20100914_05
20.09.2010 BioMérieux SA

VIDAS HIV DUO Quick
Model 30447
Lot: 839967401

IVD: HIV - multiple (1/2)

Deutsch

Français

English

Vk_20100914_13
20.09.2010 Hoya Corporation

PENTAX Halogenlichtquelle
Model BS-LH2
S/N: BS-LH2

MD: Endoscopic light source, line-powered

Deutsch

English1

English2

Vk_20100914_06
20.09.2010 TRUMPF Medizin Systeme GmbH

ORBITER patient transfer system
Model see letter

MD: Seat lifter, power-assisted

Deutsch

English

Vk_20100915_02
20.09.2010 Cardinal Health

Medi-Vac Sterile Suction Tubing
Model NEX510, NEX512, NEX610, NEX612, NEX710, NEX712, NEX56A, NEX66A, NEX76A
Lot: All lot numbers prior to Y10Kxxx

MD: Suction system tubing

Deutsch

Français

Italiano

English

Vk_20100908_02
20.09.2010 Maquet Cardiopulmonary AG

Connector tubing 1/2 x 1/2 inch.
Lot: See List

MD: Tubing connector

Deutsch

Vk_20100910_02
20.09.2010 Remel Europe Ltd.

OXOID IDEIA Lyme Neuroborreliosis
Model K602811-2
Lot: 872833

IVD: Borrelia burgdorferi immunoglobulin M (IgM)/IgG antibody IVD, kit, enzyme immunoassay (EIA)

English

Vk_20100914_18
20.09.2010 Fresenius Medical Care AG & Co. KGaA

AV-SET FMC PAED S
Model 6014611
Lot: see letter

 

AV-SET FMC BVM BTM P AED S
Model 6014621
Lot: see letter

 

AV-SN-SET FMC PAED S
Model 6014711
Lot: see letter

 

AV-SN-SET FMC PAEDIBABY S
Model 6014701
Lot: see letter

MD: Haemodialysis tubing set, single-use

Deutsch

Français

Vk_20100914_07
20.09.2010 Thoratec Corporation

HeartMate II LVAS
Model 103692 (system Controller)
S/N: All SN starting with EPC prefix

AIMD: Circulatory assist system

Deutsch

Français

English

Vk_20100915_04
20.09.2010 Innogenetics NV

INNOTEST beta-amyloid(1-42)
Model 80324
Lot: 208361

IVD: beta-amyloid(1-42) assay

Deutsch

Français

English

Vk_20100914_19
13.09.2010 Immucor, Inc.

Panocell-20
Model 0005020
Lot: 29304

IVD: Antibody identification cell panel kit

Deutsch

English

Vk_20100908_04
13.09.2010 DiaSys Diagnostic System GmbH

Bilirubin Jendrassik-Gróf FS

 

Bilirubin Auto Total FS

IVD: Bilirubin kit

Deutsch

English

Vk_20100908_01
13.09.2010 Abbott Ireland Diagnostic Division

ARCHITECT Pre-Trigger Solution
Model 6E23-65
Lot: 87164LF00, 87479LF00, 87573LF00, 88615LF00, 90291LF00

IVD: Reagent for chemiluminescence immunoassays

Deutsch

Français

Italiano

English

Vk_20100907_02
13.09.2010 Medtronic CoreValve LLC

Corevalve Delivery System

MD: Cardiac valve graft

Deutsch

Français

Italiano

English

Vk_20100910_01
13.09.2010 Instrumentation Laboratory Co.

GEM Check Coag Whole Blood Control APTT Normal
Model 6260061600
Lot: C9GC5001, C9GC5003, J9GC5004, C0GC5001

 

GEM Check Coag Whole Blood Control APTT Abnormal
Model 6260060100
Lot: F9GC2001, L9GC2002

IVD: Multiple coagulation factor IVD, control

Deutsch

Vk_20100908_06
13.09.2010 Beckman Coulter Inc.

COULTER Ac * TTM 5diff Hematology Analyzer

 

COULTER Ac * TTM 5diff Autoloader (AL) Hematology Analyzer

 

COULTER Ac * TTM 5diff Cap Pierce Hematology Analyzer

IVD: 5 part differential low/medium end blood cell counter

Français

English

Vk_20100907_01
13.09.2010 Varian Medical Systems Inc

ARIA oncology information system
Model HIT
Software Version: 8.5

 

Eclipse Treatment Planning System
Model H48
Software Version: 8.1

MD: Radiation therapy treatment record/verify system


Radiation therapy treatment planning system

Deutsch

Français

Italiano

English

Vk_20100910_03
13.09.2010 Innogenetics NV

Update

INNOTEST beta-amyloid (1-42)
Model 80324
Lot: 196524, 204108, 206189

IVD: beta-amyloid (1-42) assay

New Update Deutsch

Update Deutsch

Deutsch

New Update Français

Update Français

Français

New Update English

Update English

English

Vk_20100616_02
06.09.2010 Karl Storz GmbH & Co. KG

Calcuson & Endomat LC used in combination, suction tubing set
Model 20330342

MD: Suction system tubing

Deutsch

Vk_20100825_07
06.09.2010 Varian Medical Systems Inc

VARIAN Treatment
Model H46
Software Version: 6.6.5034, 6.6.5042, 6.6.5043, 6.6.5046, and 6.6.5048 actively using the Digital Mevatron Interface Protocols(DMIP) 5 or 6

MD: Radiation therapy treatment record/verify system

Deutsch

Français

Italiano

English

Vk_20100902_05
06.09.2010 Ortho-Clinical Diagnostics Inc.

VITROS Chemistry Products mALB Reagent, Generations 2, 3 and 4
Model 6801740

IVD: Albumin kit

Deutsch

Update Deutsch

English

Update English

Vk_20100831_10
30.08.2010 Optovue, Inc.

iVue
Model iVue100
Software Version: 1.5

MD: Ophthalmoscope

Deutsch

Français

Italiano

English

Vk_20100825_02
30.08.2010 Haag-Streit AG

Tonometermesskörper

MD: Tonometer, manually-operated

Deutsch

Français

Italiano

English

Vk_20091216_15
30.08.2010 TRUMPF Medizin Systeme GmbH

incarePORT

 

klinoPORT

MD: Utility supply system, ceiling-mounted

Deutsch

English

Italiano

Français

Vk_20100817_18
30.08.2010 Procter & Gamble Technical Centres Ltd

Kukident Super-Haftcreme extra stark
Model
Lot: 0203 xxx xxx

MD: Denture lining materials / adhesive (Prothesenhaftmittel)

Deutsch

Français

Italiano

Vk_20100824_12
30.08.2010 Varian Medical Systems Inc

Optical Guidance Platform (OGP)
Model HZ1
S/N: See List

MD: Stereotactic-radiosurgical linear accelerator system

Deutsch

Français

English

Vk_20100826_02
30.08.2010 Varian Medical Systems Inc

Eclipse Treatment Planning System
Model H48
Software Version: 7.3.10 through 8.6.15

MD: Radiation therapy treatment planning system

Deutsch

Français

Italiano

English

Vk_20100825_09
30.08.2010 DePuy International Limited

ASR Articular Surface Replacement and ASR XL Monoblock Metal-on-Metal System

MD: Femoral Component and Acetabular Component

Deutsch

Français

Italiano

Vk_20100826_06
30.08.2010 Planmeca Oy

Planmeca Compact

MD: Dental delivery system

Deutsch

Français

Italiano

English

Vk_20100825_08
30.08.2010 Synthes GmbH

Implant Holder f/SynFix-LR
Model 03.802.039
Lot: All

MD: Orthopaedic implant/trial-implant holder

Deutsch

Français

English

Vk_20100824_13
23.08.2010 Philips Medical Systems

HeartStart MRx
Model M3535A / M3536A / M3536J/ M3536MC
S/N: see letter

MD: Defibrillator/monitor

Deutsch

Français

Italiano

English

Vk_20100819_03
23.08.2010 BrainLAB AG

Update

KOLIBRI Navigation Station 2.0 (with mobile camera stand 2.0)

MD: Robotic surgical system, navigation

Deutsch

Update Deutsch

English

Update English

Français

Update Français

Italiano

Update Italiano

Vk_20100727_01
23.08.2010 Dräger Medical AG & Co.

Oxylog 3000
S/N: see letter

MD: Transport ventilator

Deutsch

Vk_20100819_01
23.08.2010 Roche Diagnostics GmbH

Tina-quant D-Dimer Gen. 2
Model 04912497190, 04912551190, 05077753190
Lot: 62838001, 62837701, 62841101

IVD: D-dimer kit

Deutsch

Français

English

Vk_20100817_13
23.08.2010 Nova Biomedical

Nova Biomedical Ionized Calcium Sensor
Model 15264, 27813, 37272, 42458

 

Nova Biomedical Ionized Magnesium Sensor
Model 15265, 37271, 45172

IVD: Calcium electrode, Magnesium electrode

English

Vk_20100817_16
23.08.2010 Accuray Inc.

CyberKnife Robotic Radiosurgery System

MD: Linear accelerator system

Deutsch

Français

Italiano

Vk_20100817_17
23.08.2010 Schülke & Mayr GmbH

thermosept alka clean forte / thermosept NKZ / Thermosept NKP / ThermoDent Neutralizer
Lot: all

 

Thermosept DK / Thermosept ED

MD: Detergent




MD: Disinfectant surgical instrument

Deutsch

Français

Italiano

English

Vk_20100818_15
23.08.2010 CIBA Vision Corporation

FreshLook Colors
Model Sappire Blue, Violet
Lot: Sapphire Blue Lot: 304980, 312944; Violet Lot: 302592

MD: Contact lens

Deutsch

Vk_20100817_05
23.08.2010 Allergan Medical S. A.

Easyband
Model Version 3
S/N: see list

 

Easyband
Model Gen 0
S/N: see list
Software Version: FIM 05023

 

Easyband
Model Version 2
S/N: see list

AIMD: Gastric band

English1

English2

Vk_20100817_07
23.08.2010 Zimmer GmbH

Wallaby I PE-Inlay ultra-congruent, Model see List
Lot: up to 2249344

 

Wallaby I PE-Inlay normo-congruent, Model see List
Lot: up to 2249344

MD: Knee prosthesis, internal, tibial component

Deutsch

Français

Vk_20100809_01
23.08.2010 Philips Medizinsysteme

Water trap for IntelliVue Anesthetic Gas Modules - G1/G5
Model M1657B
Lot: see letter

MD: Patient monitoring system module, multiple-gas

Deutsch

Français

English

Vk_20100819_02
16.08.2010 BioMérieux SA

VIDAS RUB IgG II
Model 30221
Lot: 837810801

IVD: Rubella virus immunoglobulin G kit

Deutsch

Français

Vk_20100811_05
16.08.2010 Elekta CMS Software

Focal
Software Version: Release 4.50.00 and higher

MD: Radiation therapy treatment planning system

English

Vk_20100804_04
16.08.2010 3M Health Care

3M Red Dot Monitoring Electrode with Foam Tape and Sticky Gel
Model 2560
Lot: 2012-05-CC, 2012-05-CD, 2012-05-CE, 2012-05-CF, 2012-05-CG,2012-05-CH, 2012-05-CI, 2012-05-CJ, 2012-05-CK, 2012-05-CM2012-05-CN, 2012-06-CY, 2012-06-CZ, 2012-06-DA, 2012-06-DB.

MD: Electrode

Deutsch1

Deutsch2

Français1

Français2

English1

English2

Vk_20100812_09
16.08.2010 DiaSorin Deutschland GmbH

LIAISON Analyzer
Model 9450200
S/N: all

 

LIAISON LAS Analyzer
Model I0041
S/N: all

IVD: Analyser, laboratory, immunoassay, chemiluminescent

Deutsch

Français

English

Vk_20100810_10
16.08.2010 Abbott Laboratories

CELL-DYN Sapphire Vent Head Assembly
Model 08H53-02

 

CELL-DYN Sapphire Accessory Kit
Model 08H03-01

 

CELL-DYN Sapphire
Model 08H00-01

IVD: Haematology analyser, cell-differential

Deutsch

Français

Vk_20100812_05
16.08.2010 Abbott Point of Care

i-STAT Level 2 Control
Lot: B09342, B09154

IVD: Blood gas control

Deutsch

Français

English

Vk_20100811_02
16.08.2010 DePuy International Limited

DePuy Summit Universal Broach Handle
Model 257000000
Lot: A1109, A1209, A0210 and A0310

MD: Surgical instrument handle

English

Vk_20100810_04
16.08.2010 Stryker Orthopaedics

Scorpio T72 Tibial Insert Trial
Model T72-2, T72-3, T72-5, T72-6
Lot: All

MD: Trial joint prosthesis

Deutsch1

Deutsch2

Vk_20100813_04
09.08.2010 Integra LifeSciences (Ireland) Ltd.

CUSA NXT Service Module
Model CUSANXT2
S/N: NXT1022

MD: Trolley, electromechanical device

English

Vk_20100803_13
09.08.2010 Ortho-Clinical Diagnostics Inc.

VITROS 3600
Software Version: 1.4 and below

 

VITROS 5600
Software Version: 1.4 and below

IVD: Clinical chemistry analyser

Immunoassay analyser

Deutsch

English

Vk_20100804_05
09.08.2010 Beckman Coulter Inc.

UniCel DxI 600 Access Immunoassay System
Software Version: 4.3

 

UniCel DxI 800 Access Immunoassay System
Software Version: 4.3

IVD: Immunoassay analyser

Deutsch

English

Français

Vk_20100805_03
09.08.2010 Beckman Coulter Inc.

Access Thyroglobulin Antibody II Reagent
Model A32898
Lot: 916271, 917073, 918433

IVD: Thyroglobulin autoantibody kit

Français

English

Vk_20100805_05
09.08.2010 Bio-Rad Laboratories Deeside

in2it (I) A1c Test Cartridges
Model 281-0001EX
Lot: all

 

in2it (II) A1c Test Cartridges Prescription Home Use
Model 281-0001
Lot: all

 

in2it A1c Test Cartridges Self Test
Model 281-0001ST
Lot: all

IVD: Glycated haemoglobin kit

English

Vk_20100803_14
09.08.2010 MammendorferInstitut für Physik und Medizin GmbH

Tesla Plus
Model EFTES03D
S/N: MIMT980031

MD: Patient monitoring system, general physiology, multi-patient

Deutsch

English

Vk_20100804_03
09.08.2010 Becton Dickinson Diagnostic Systems

BD BBL Staphyloslide Latex Test
Model 240952
Lot: 16604110, 16605410, 16640910, 16679310, 16750910, 16778710, 16781210, 16831557

IVD: Streptococcus antigen kit

Français

Vk_20100727_26
02.08.2010 Heraeus Medical GmbH

PALAMIX uno 1x80
Model 66036743
Lot: 200177, 200178, 200179, 200180, 200181, 200182, 200183, 200184, 200185

 

PALAMIX DUO 2x80
Model 66036746
Lot: 500040

 

PALAMIX Hip Set
Model 66044411
Lot: 800011, 800012

MD: Orthopaedic cement mixer, manual

Deutsch

English

Vk_20100727_27
02.08.2010 Merz Pharmaceuticals GmbH

Novabel
Model 40800, 49021
Lot: All batches

MD: Tissue reconstructive material

Deutsch

Français

Vk_20100726_02
02.08.2010 Dräger Medical AG & Co.

Zeus Infinity Empowered
Model MK04000
Software Version: SW1.00.36

MD: Anaesthesia unit

Deutsch

Français

Vk_20100728_07
02.08.2010 Beckman Coulter Inc.

Estrone RIA
Model DSL-8700
Lot: 992637, 100115A, 100205A, 100205RA, 100226A, 100319A, 100409A, 100409RA

IVD: Oestrone kit

Deutsch

English

Vk_20100728_01
02.08.2010 Venner Medical (Deutschland) GmbH

Pega Tube
Model 10250
Lot: S090460

MD: Light source, fibreoptic

Deutsch

English

Vk_20100720_05
02.08.2010 GE / OEC Medical Systems Inc.

GE OEC 9800 (mit Celeron Single Board Computer)
Software Version: V29

MD: X-ray system workstation, diagnostic, multi-purpose

Deutsch

Français

Italiano

Vk_20100727_02
02.08.2010 Boston Scientific GmbH

Contak Renewal 3 HE

 

Contak Renewal 4 RF HE

 

Contak Renewal 4 AVT HE

 

Contak Renewal 4 AVT

 

Vitality DR HE

 

Contak Renewal 3 RF

 

Contak Renewal 3 RF HE

 

Contak Renewal 3

 

Contak Renewal 4
Models see list

AIMD: Dual-chamber implantable defibrillator<br>Single-chamber implantable defibrillator

Deutsch

Français

Italiano

English

Vk_20100727_05
02.08.2010 Stryker Endoscopy

Crossfire Consoles
Model range from 475-000-000

MD: Electrosurgical diathermy system generator, cutting and coagulation, accessory

Deutsch

Vk_20100727_21
02.08.2010 Siemens Medical Solutions USA Inc.

ACUSON & SONOLINE Antares
Models 05936518, 08653771, 10037593, 10032747 , 10037592,10032746, 10037591, 10038202, 10040729, 10040728
S/N: all
Software Version: product versions 4.0 and 5.0

 

ACUSON S2000
Model 10041461

MD: Scanner, ultrasonic, general-purpose
Ultrasound imaging system, general-purpose

Deutsch

Français

Vk_20100722_03
02.08.2010 Medtronic Inc.

Everest Inflation Device and Survival Kit
Model AC2200, AC3200, AC3205P.
Lot: 50517324, 50517330, 50517331, 50517332, 50517333, 50517334, 50517336,50517337, 50517339, 50519716, 50519717, 50519718

MD: Catheter-balloon inflator, single-use

Deutsch

Vk_20100727_04
02.08.2010 Siemens Healthcare Diagnostics Inc

ADVIA Centaur HIV Ag/Ab combo (CHIV) Assay
Model 06520528
Lot: 48795005, 48960005, 50134005, 50407005, 50836006, 50952006, 51867008, 52094008, 54146008, 55146010, 55041011, 55291011

IVD: Human immunodeficiency virus multiple antibody kit

Deutsch

English

Vk_20100728_02
02.08.2010 Roche Molecular Systems Inc.

Cepheid LightCycler CMV Quant Kit-IVD
Model 04 845 854 001
Lot: 70012203, 70012207

IVD: Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Français

Vk_20100727_23
02.08.2010 Stryker Endoscopy

Pkg. Disposable Scope Warmer
Model 0502360000

MD: Telescope warmer

Deutsch

Vk_20100727_19
02.08.2010 Codman and Shurtleff, Inc

Codman Surgical Patties
Model 80-1396 / 80-1399

MD: Neurosurgical sponge

Deutsch

Vk_20100727_03
26.07.2010 GE Healthcare Clinical Systems

Giraffe In-Bed Scale
S/N: delivered between October 2007 and August 2008
Software Version: 1.74 or 2.20 (versions <=1.0 or >=2.72 are not affected)

MD: Scale, bed

Deutsch

Vk_20100722_11
26.07.2010 Synovis Surgical Innovation

PSD Gel packaged with: Peri-Strips Dry Staple Line Reinforcement with Apex Processing, Peri-Strips Dry with Veritas Collagen Matrix Staple line Reinforcement Replacement Gel 3-packs
Model PSD 6006-ECH-V
Lot: 5767276-1305047

MD: Implantable-device lubricant

English

Vk_20100720_07
26.07.2010 Beckman Coulter Inc.

SYNCHRON System Immunoglobulin A (Ig-A) Reagent
Model 467920
Lot: M812164; M902345

IVD: Immunoglobulin A kit

Deutsch

Français

English

Vk_20100721_01
26.07.2010 Caridian BCT, Inc.

COBE Spectra White Blood Cell Set - Functionally Closed
Model 70620
S/N: lS15239

 

COBE Spectra White Blood Cell Set
Model 70600
S/N: lS15238

MD: Blood transfer set

Deutsch

Français

Italiano

English

Vk_20100722_01
26.07.2010 Fresenius Medical Care (Schweiz) AG

Haemodialysis tubing set, single-use
Lot: see Letter

MD: Tubing set, dialysis/haemodialysis

Deutsch

Français

Italiano

Vk_20100722_02
26.07.2010 Philips Medical Systems

IntelliVue Patient Monitor
Model M8005A, M8007A

MD: Patient monitoring system, general physiology, single-patient

Deutsch

Français

Italiano

English

Vk_20100721_13
26.07.2010 HEINE Optotechnik GmbH & Co. KG

HEINE XP Disposable Laryngoscope Blade
Model MAC 3 / F-000.22.763
Lot: April 2010 (see stamp)

MD: Rigid laryngoscope

English

Vk_20100722_07
26.07.2010 Varian Medical Systems Inc

Clinac 2100
Model H14, H27, H29
S/N: H272427, H182012, H293993, H293928, H293649, H140864, H140797, H293981, H293577, H293652, H293818, H293778,

MD: Linear accelerator system

Deutsch

Français

Italiano

English

Vk_20100721_06
26.07.2010 Brahms Aktiengesellschaft

Brahms free Beta-hCG Kryptor
Model 809.075
Lot: 09045

IVD: Automated immunofluorescent assay for the determination of free free hCG

Deutsch

Français

English

Vk_20100721_03
26.07.2010 Invacare France Opérations

Magnolia
S/N: From 050917698438 to 051020116183

MD: Wheelchair, attendant-driven

Deutsch

Vk_20100715_05
19.07.2010 Osypka Medical GmbH

Update

PACE 203H
S/N: 0706101 bis 1001
Software Version: V1 .21,22

 

Pace 300
S/N: 0706101 bis 1001
Software Version: V1 .21,22

MD: Externer Zweikammer Schrittmacher

Deutsch

Update Deutsch

Français

Italiano

Vk_20100701_01
19.07.2010 Bausch & Lomb Inc.

ReNu Multi-purpose Solution & Multiplus
Lot: see Letter

MD: Contact lens solution

Deutsch

Français

Italiano

Vk_20100706_27
19.07.2010 DiaSorin S.p.A.

Liaison VZV IgG
Model 310850
Lot: 081032

 

Liaison VZV IgM
Model 310860
Lot: 095028

IVD: Varicella-zoster virus Immunoglobulin G kit

Italiano

English

Vk_20100713_09
19.07.2010 Siemens Healthcare Diagnostics Ltd

ADVIA Centaur HBc Total (HBCT)
Model 07566733
Lot: 49471033, 50694033, 51071033, 51628033, 52260033, 52809033, 53674033

IVD: Hepatitis B virus core total antibody kit

Deutsch

Français

Vk_20100713_12
19.07.2010 Stryker Instruments

M1 Ambulance Cot
Model 6100
S/N: see letter

MD: Ambulance stretcher

Deutsch

Français

Vk_20100706_24
19.07.2010 Volcano Corporation

Volcano s5 Imaging System
Model 435-0602.(01-05)
Software Version: 3.2

MD: Ultrasound imaging system, cardiovascular

Deutsch

Italiano

Vk_20100713_10
19.07.2010 GE Medical Systems

CARESCAPE Monitor B850
Model see letter

MD: Patient monitoring system, general physiology, single-patient

Deutsch

Français

Italiano

Vk_20100713_08
19.07.2010 Willy Rüsch GmbH

TracheoFlex Tube
Model see letter
Lot: see letter

 

LaryngoFlex Tube
Model see letter
Lot: see letter

MD: Basic tracheostomy tube, single-use

Deutsch

Français

Italiano

English

Vk_20100714_05
12.07.2010 GE Medical Systems Information

Innova 2000
Model 2252302, 2252302-2, 2252302-3 and 2393112.

MD: Fluoroscopic x-ray system, angiography, stationary, digital

Deutsch

Français

Vk_20100706_07
12.07.2010 Roche Diagnostics Ltd

AMPLILINK Software for COBAS AmpliPrep/COBAS TaqMan
Model 05666678001
Software Version: 3.1.x, 3.2.x

IVD: Sample processing system

Deutsch

Français

English

Vk_20100629_02
12.07.2010 Axis-Shield PoC AS

NycoCard U-Albumin
Model 128
Lot: 10145496, 10145497, 10145536, 10145537

IVD: Albumin kit

Deutsch

Français

Italiano

English

Vk_20100706_18
12.07.2010 Integra Neurosciences Implants

NeuroBalloon Catheter
Model 7CBD10
Lot: all lots manufactured since October 2009

MD: Endotherapy device, non-active, single-use

Deutsch

Français

English

Vk_20100708_01
12.07.2010 Terumo Medical Corporation

Destination Carotid Guiding Sheath
Model RSC01, RSC02, RSC03, RSC04
S/N: see letter
Lot: see letter

MD: Catheter introducer

Deutsch

English

Vk_20100706_09
12.07.2010 St. Jude Medical

Engage Venous Introducer
Model C408502, C408527; C408513, C408524
Lot: C408502 (3110892, 3118797,); C408527 (3105838); C408513 (3107645); C408524 (3109782)

MD: Cardiac device introducer

Deutsch

Français

Italiano

English

Vk_20100707_04
12.07.2010 Hospira (Dominican Republic)

Suction system, receptal
Model OL2129701 Receptal 1L PVC Liner OL21297W1 Receptal 1L PVC Liner OF8079701 Receptal 1.5L PVC Liner OG6619701 Receptal 2L PVC Liner OG9159701 Receptal 2L PVC Liner OE0989701 Receptal 2L PVC Liner OF8069701 Receptal 2L P

MD: Suction system canister liner

Deutsch

Français

English

Vk_20100624_04
12.07.2010 Spectranetics Corporation

QuickCat Extraction Catheter
Model 60090-01
S/N: see letter
Lot: see letter

MD: Embolectomy/thrombectomy catheter

Deutsch

Français

Italiano

Vk_20100706_08
12.07.2010 Beckman Coulter Inc.

SYNCHRON Rheumatoid Factor (RF) Reagent
Model 475136
Lot: M907325

IVD: Rheumatoid factor kit

Deutsch

English

Vk_20100706_25
12.07.2010 Advanced Neuromodulation Systems, Inc.

Exclaim & Lamitrode leads
Model 3224, 3243, 3246, 3266, 3267, 3268, 3269, 3283, 3286, 3208, 3210, 3219, 3214, 3240, 3254, 3255, 3244, 3262, 3263, 3245, 3264, 3265, 3280, 3288, 3289, 3228

MD: Neural-tissue electrical stimulation lead

Deutsch

Français

Italiano

English

Vk_20100624_05
05.07.2010 United States Surgical

Protack Fixation device
Model 174006
Lot: P9H1081, P9M0112, P0B0753, P0A0021 and P0A0723

MD: Surgical binding material anchor set

Deutsch

Vk_20100629_12
05.07.2010 LEVO AG

LEVO C3
S/N: 913'000 - 913'123

MD: Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible

Deutsch

Français

English

Vk_20100623_02
05.07.2010 DiaSys Diagnostic System GmbH

Calcium P FS
Model 11181
Lot: all

IVD: Calcium kit

Deutsch

Vk_20100630_04
05.07.2010 GE Healthcare

GE Centricity RIS
Software Version: 4.1.24, 4.1.25 and 4.1.26

MD: Radiology information system

Deutsch

Français

Italiano

Vk_20100630_02
05.07.2010 Gebrüder Martin GmbH & Co. KG

Molina Screwdriver for pins
Model 51-600-85

MD: Surgical screwdriver, reusable

English

Vk_20100629_11
01.07.2010 Semperit Technische Produkte GmbH

Sempermed supreme
Lot: 10 G0137

MD: Hevea-latex surgical glove, non-powdered

Deutsch

Français

Vk_20100630_12