Archiv

Archives liste des retraits de produits

Liste des retraits de produits et autres mesures correctives (FSCA) – Archive
Date Fabricant Nom commercial Description du produit Informations Nº de référence Swissmedic
27.06.2011 Stryker Spine

MANTIS ROD INSERTER (INNER SHAFT + ASSEMBLY)
Model 48284052 - 48284053 - IS2097MAN
Lot: All

MD: Fixation device

English

Vk_20110622_14
27.06.2011 Zimmer GmbH

PE Alpha Hooded Insert HH/28
Model 01.00010.308
Lot: 2463499

 

PE Alpha Hooded Insert LL/28
Model 01.00010.312
Lot: 2462484

 

Durasul Alpha Insert Neutral GG/28
Model 01.00013.207
Lot: 2541769

 

Durasul alpha Insert Neutral KK/36
Model 01.00013.711
Lot: 2541553

 

Durasul Alpha Insert With Rim MM/28
Model 01.00013.313
Lot: 2541789

 

Durasul Alpha Insert With Rim II/28
Model 01.00013.309
Lot: 2541785

MD: Acetabulum prosthesis

Deutsch1

Deutsch2

Deutsch3

Français1

Français2

Français3

English1

English2

English3

Vk_20110614_03
27.06.2011 Karl Beese GmbH & Co

Präpariertupfer r 8x8 cm Rö p.P à 100 St. Steril, dopp. Verp.
Model REF -4311
Lot: 1010-157

 

OP- Set-1, steril doppelt verpackt mit Präpariertüpfer
Model REF -1171
Lot: 7230-1104

MD: Sponge, x-ray detectable

Deutsch1

Deutsch2

Deutsch3

English1

English2

Vk_20110601_09
27.06.2011 Physio-Control Corporation

Lifepak 500
Model 99401-xxxxxx

MD: Defibrillation/physiologic monitoring system

Deutsch

English

Vk_20110621_03
27.06.2011 Stryker Orthopaedics Cork

V40 Unipolar Heads
Model 4656-0-041, 4656-0-043, 4656-0-044, 4656-0-046, 4656-0-047, 4656-0-049, 4656-0-051, 4656-0-052, 4656-0-054, 4656-0-056
Lot: All lots of the listed catalog numbers

MD: Hip prosthesis, internal, femoral head component

Deutsch

Update Deutsch

Français

Update Français

English

Update English

Vk_20110525_12
27.06.2011 Schülke & Mayr GmbH

Thermosept ED

 

Thermosept ER

MD: Disinfectant

Detergent

Deutsch

English

Vk_20110622_02
27.06.2011 GE / OEC Medical Systems Inc.

Sensor cable for IT2500, IT2500 Plus, IT3000, IT3500, IT3500Plus
Model Transmitter: 1002008, 1004587, 1007914-NAV / Receiver: 1001989, 1001990, 1004069, 1007907-NAV
Lot: all

MD: Cable

Deutsch

Vk_20110622_01
27.06.2011 Gambro Lundia AB

Prismaflex Continous Replacement System
Software Version: Software version higher than or equal to 5.00 and lower than or equal to 6.00

MD: Haemodialysis system

Deutsch

Français

English

Vk_20110622_08
27.06.2011 Beckman Coulter Inc.

Access HAV Ab Reagent
Model 34200
Lot: 094059, 094060, 094061, 094062

IVD: Hepatitis A virus total antibody kit

Deutsch

Français

English

Vk_20110622_11
27.06.2011 Elekta Limited

DMLC, Accelerator System Collimator
Model MRT 14431, 14441, 14451
S/N: All

MD: Medical linear accelerator

English

Vk_20110608_03
27.06.2011 Beckman Coulter Inc.

Access Ostase Calibrator Kit
Model 37305
Lot: 013490, 015210, 018854, 020419, 022834, 109632

 

Access Ostase QC Kit
Model 37309
Lot: 911585, 015211, 018855, 020420, 021285, 021640

IVD: Bone alkaline phosphate, IC

Deutsch

Français

English

Vk_20110622_13
27.06.2011 Natus Europe GmbH

Echo-Screen / AccuScreen

MD: Audiometric evoked-potential unit

Deutsch

Vk_20110622_10
27.06.2011 Terumo CORPORATION

Runthrough NS Tapered PTCA Guidewire
Model TW-DP418FH
Lot: 101129, 101203, 101216, 101223

MD: Cardiac catheter guidewire, single-use

Deutsch

English

Vk_20110623_04
27.06.2011 Becton Dickinson Biosciences

BD FACS 7-Color Setup Beads
Model 335775
Lot: 83284, 87471, 02073, 02450, 02452, 02453

IVD: Flow Cytometry Controls, Setup Beads

Deutsch

English

Vk_20110622_09
27.06.2011 Maquet Cardiopulmonary AG

HL20
Model 4 pump console
Lot: all

 

HL20
Model 5 pump console
Lot: all

MD: Cardiopulmonary bypass system, roller type

English

Vk_20110628_01
27.06.2011 Maquet Cardiopulmonary AG

HL20 Twin Pump Module
Model 703323 / 706159
S/N: see letter

MD: Cardiopulmonary bypass system, roller type

English

Vk_20110628_02
20.06.2011 Ventana Medical Systems Inc

Update

iView Universal DAB Detection Kit
Model 760-091 (05266157001)

 

ultraView Universal DAB Detection Kit, Model 760-500 (05269806001)

IVD: DNA in situ hybridization kit

Update Deutsch

Update Français

English

Vk_20110525_05
20.06.2011 Varian Medical Systems Inc

Clinac Linear Accelerator
Model H14, H19, H29
S/N: see letter

 

TrueBeam
Model H14, H19, H29
S/N: see letter

MD: Linear accelerator system

Deutsch

Français

Italiano

English

Vk_20110616_04
20.06.2011 Philips Healthcare

MX8000 Dual v. Exp
Model 728130
S/N: all

MD: Full-body CT system

Deutsch

English

Vk_20110615_11
20.06.2011 Haemonetics Corporation

Plasma collection HS bowl
Model 622HS-00, 623HS-00, 625HS-00, 782HS-P
Lot: all

MD: Apheresis system tubing set

English

Vk_20110614_04
20.06.2011 United States Surgical

Sofsilk
Lot: D1B0584X, D1CO245X, D1CO292X

 

Surgilon
Lot: D1B0584X, D1CO245X, D1CO292X

 

Ticron
Lot: D1B0584X, D1CO245X, D1CO292X

MD: Silk suture, sterile; Suture, nylon; Polyester suture

Français

English

Vk_20110615_09
20.06.2011 Ziehm Imaging GmbH

Ziehm Solo
Model 50024, 50030, 50072, 50056, 50073
S/N: See list

MD: Radiographic/fluoroscopic unit, general-purpose

Deutsch

Vk_20110608_02
20.06.2011 BrainLAB AG

Kolibri Navigation Software Cranial/ENT
Model 22204E: KOLlBRI NAVIGATION SW CRANIAL 2.7 / 22201F: KOLlBRI NAVIGATION SW ENT 2.7
Software Version: 2.7

 

VectorVision Navigation Software Cranial/ENT
Model 22040G: VV NAVIGATION SW CRANIAL 7.9 / 22076G: VV NAVIGATION SW ENT 7.9
Software Version: 7.9

 

Cranial/ENT Navigation Software Unlimited
Model 22208: CRANIAL UNLIMITED NAV SW 1.0 / 22212: ENT UNLIMITED NAVIGATION SOFTWARE 1.0
Software Version: 1.0

 

Cranial/ENT Navigation Software Essential
Model 22207: CRANIAL ESSENTIAL NAV SW 1.0 / 22211: ENT ESSENTIAL NAVIGATION SOFTWARE 1.0
Software Version: 1.0

MD: Robotic surgical navigation system

Deutsch

Français

Italiano

English

Vk_20110615_01
20.06.2011 Cordis Europa, N.V

Cypher Select + Sirolimus-eluting Coronary Stent
Model CRB28XXX and CRB33XXX
S/N: All
Lot: CRB28, Nov.2011 and prior // CRB33, July 2011 and prior

MD: Drug-eluting coronary artery stent

Deutsch

Français

English

Vk_20110617_01
20.06.2011 Siemens Medical Solutions USA Inc.

ACUSON SC2000
Model 10433816
Software Version: All versions at VA15x

MD: Scanner, ultrasonic, general-purpose

Deutsch

English

Vk_20110615_10
20.06.2011 Invivo Corporation

Expression MRI Patient Monitoring System
Model 865214
S/N: see letter

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

English

Deutsch

Vk_20110616_03
20.06.2011 BD Becton Dickinson

BD Venflon Pro Safety
Model 393227
S/N: All
Lot: 0333842, 0355277, 0355278

MD: Peripheral vascular catheter, infusion

English

Vk_20110617_02
20.06.2011 Welch Allyn Inc

Propaq LT Large Colour Display
S/N: All

MD: Blood gas/pH monitor, extracorporeal

Deutsch

Français

Italiano

English

Vk_20110615_12
14.06.2011 WaveLight AG

Update

WaveLight FS200
Model 1025
Software Version: Version Blue, Service Pack 2

MD: Keratome, line-powered

Deutsch

Deutsch2

Français

Français2

Vk_20110419_03
14.06.2011 HemoCue AB

HemoCue Glucose 201 Microcuvettes
Model 110715, 110716, 110717, 110718, 110719, 110705, 110706
Lot: see letter

IVD: Glucose rapid test system reagent

Deutsch

English

Vk_20110607_02
14.06.2011 Cambridge Endoscopic Devices, Inc.

Autonomy Laparo-Angle
Model LA1101-01 and LA1101-12
Lot: see letter

MD: Endotherapy scissors, flexible, reusable

English

Vk_20110607_04
14.06.2011 Spacelabs Medical

SL Dual Capnography Module
Model 91517

MD: Patient monitoring system module, multiple-gas

Deutsch

Français

Vk_20110607_03
14.06.2011 Terumo Cardiovascular Systems

Terumo CDI Monitoring Systems
Model 500AVHCT, 500AHCT, 500AV, 500A, 100, 101

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

Deutsch

Français

English

Vk_20110609_05
14.06.2011 GE Medical Systems LLC

Discovery VCT, Discovery RX VCT, Discovery STE, Discovery RX systems
Software Version: 07MWHL36.4, dm09_hlsp1.23, 07MWDVCT36.4, dm09_dvctsp1.23

 

Discovery ST systems with Dimension console
Software Version: 07MWHL36.4, dm09_hlsp1.23

MD: PET system

Deutsch

Français

Vk_20110607_09
14.06.2011 NAL VON MINDEN GmbH

NADAL FOB Test (Test Cassette)
272001
Lot: FOB1009001

IVD: Faecal occult blood rapid test device

Deutsch

Français

Vk_20110420_19
06.06.2011 Moor Instruments Ltd

MS2 Mobile Stand (used with the MoorLD12 Laser Doppler Imager)
S/N: all

MD: Laser blood flowmeter

English

Vk_20110531_10
06.06.2011 GE Medical Systems

PROCARE B30 Patient Monitor
Software Version:
L-DICU08.2.1.6

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

Deutsch

English

Vk_20110601_08
06.06.2011 Smith & Nephew Orthopaedics AG

RT-PLUS MODULAR Stepped Drill and ERT-PLUS MODULAR Tibial Drill Guide
Model 240445, 240449
Lot: see list 240449: B70869, B71158, B71221, B71901, B72149, B73887

MD: Guide, drill

Deutsch

English

Vk_20110601_02
06.06.2011 Intraplant Medizintechnik GmbH

ANA.NOVA MII Hals / Neck
Model 91210, 91211, 91212, 91213
Lot: all since 04/2007

MD: Prosthesis, joint, hip, total

Deutsch

English

Vk_20110531_11
06.06.2011 Varian Medical Systems Inc

ARIA
Model HIT
S/N: see list
Software Version: RT Chart Application v8.0 through 8.9

MD: Radiology information system

Deutsch

Français

Italiano

English

Vk_20110601_03
06.06.2011 GE Healthcare

GE Centricity Enterprise Web
Software Version: 3.0.x

MD: Picture archiving and communication system application software, radiology

Deutsch

Français

Vk_20110601_12
06.06.2011 Beckman Coulter Inc.

Flow-Set Fluorospheres
Model 6607007
Lot: 7524013F

IVD: White blood cell control

Français

English

Vk_20110601_07
06.06.2011 Siemens AG

Ysio F
Model 10281013

 

Ysio S
Model 10281163

MD: Stationary basic diagnostic x-ray system, digital

Deutsch

Français

English

Vk_20110531_02
06.06.2011 Smith & Nephew Inc.

Drill Tip Wire 1.8mm x 400mm
Model 71070372
Lot: see letter

 

Drill Tip Wire with Stopper 1.8mm x 400mm
Model 71070373
Lot: see letter

MD: Orthopaedic bone pin, non-biodegradable

English

Vk_20110531_12
30.05.2011 Nikkiso Co., Ltd.

Update

Dialysate Purification filter EF-02 D
Lot: ab LOT-Nummer091124

MD: Dialyser

Deutsch

Update Deutsch

Français

Update Français

Italiano

Update Italiano

English

Vk_20101130_10
30.05.2011 Boston Scientific Corporation

Innova Self-Expanding Stent System
Model See letter
Lot: See letter

MD: Stent, vascular

Deutsch

English

Vk_20110526_03
30.05.2011 Elekta CMS Software

XiO Treatment Planning Software
Model See letter
Software Version: 4.50.00 and above

MD: Radiation therapy treatment planning system application software

Deutsch

Français

Italiano

Vk_20110216_17
30.05.2011 Smiths Medical International Ltd

TranStar pressure monitoring set
Model see letter

 

LogiCal pressure monitoring set
Model see letter

 

NovaTrans pressure monitoring set
Model see letter

MD: Invasive blood pressure monitoring tubing set

Deutsch

Français

Vk_20110525_11
30.05.2011 VBM Medizintechnik GmbH

Jet-Ventilations-Katheter für Babies
Model 30-02-918-1
Lot: 28326 / 30068 / 32191K / 33607

 

Jet-Ventilations-Katheter für Kinder
Model 30-02-914-1
Lot: 28327/ 30067 / 310651 / 32190K / 32642 / 33691

MD: Jet ventilation endotracheal tube

Deutsch

Vk_20110527_06
30.05.2011 Ventana Medical Systems Inc

ultraView Universal DAB Detection Kit
Model 760-500 (05269806001)
Lot: A05885, B00988

IVD: DNA in situ hybridization kit

Deutsch

Français

English

Vk_20110525_02
30.05.2011 Cyberonics, Inc.

VNS Therapy Demipulse and Demipulse Duo Generator
Model 103
S/N: 6234

AIMD: Vagus nerve electrical stimulation system, antiseizure

Deutsch1

Deutsch2

Français1

Français2

Italiano1

Italiano2

English1

Vk_20110525_06
30.05.2011 Siemens AG Healthcare

syngo.plaza ; system label 105 92 457
Model System label 105 92 457
Software Version: SW VersionVA 10A, V A 20A including all related hotfixes

MD: Picture archiving and communication system, radiology

English

Vk_20110429_01
30.05.2011 Leica Biosystems Newcastle Ltd

Bond Oracle HER2 IHC System
Model TA9145
Lot: 12315, 13341

IVD: Immunohistologic kit

Deutsch

Français

Italiano

English

Vk_20110524_02
30.05.2011 GE Hangwei Medical Systems Co., Ltd

GE Medical Systems LLC

GE Healthcare Japan Corporation

Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa Excite 1.5T & 3T
S/N: All systems with Magnet Run-down Units (5196918) shipped to the field between October/01/2009 - December/10/2010.

 

OpenSpeed, GE 1.5T Signa HDe
S/N: All systems with Magnet Run-down Units (5196918) shipped to the field between October/01/2009 - December/10/2010.

 

Brivio MR355, Optima MR360
S/N: All systems with Magnet Run-down Units (5196918) shipped to the field between October/01/2009 - December/10/2010.

MD: MRI system, full-body,

Deutsch

Français

Italiano

Vk_20110511_11
30.05.2011 Siemens AG

Ysio F
Model 10281013

 

Ysio S
Model 10281163

MD: Stationary basic diagnostic x-ray system, digital

Deutsch

Français

English

Vk_20110531_02
23.05.2011 GENDEX Dental System

Orthoralix 8500 DDE

 

Orthoralix 9200 DDE

MD: Dental x-ray system, general-purpose

Deutsch

English

Vk_20110517_03
23.05.2011 Beckman Coulter Inc.

UniCel DxC and Synchron Systems LX Calibrator 1
Model 468405
Lot: Lots prior to M005558

IVD: Calibrator

Deutsch

Français

English

Vk_20110518_11
23.05.2011 Maquet GmbH & Co. KG

Connection fixtures
Model 1002.65A0; 1002.65S0
Lot: all

MD: Headrest

Deutsch

English

Vk_20110518_13
23.05.2011 International Technidyne Corp.

Hemochron Jr. PT Cuvettes
Model J201
Lot: see list

IVD: Prothrombin time (PT) IVD, kit, clotting, rapid

Deutsch

Français

Italiano

English

Vk_20110518_05
23.05.2011 Biotronik AG

Passeo-18
Lot: see Field Safety Notice

MD: Balloon peripheral angioplasty catheter

Deutsch

Français

Italiano

English

Vk_20110517_12
23.05.2011 Maquet Critical Care AB

FLOW-i
Model 66 77 200 and 66 77 300

MD: Anaesthesia workstation, general-purpose

English

Vk_20110517_01
23.05.2011 Beckman Coulter Inc.

UniCel DxH 800 Coulter Cellular Analysis System
Model 629029
Software Version: all

IVD: Haematological cell analyser IVD, automated

Deutsch

English

Vk_20110518_10
23.05.2011 GCE s.r.o.

Pressure reducing valve
Model see letter
S/N: all manufactured between 2008 and 2009

MD: Pressure reducing valve

Deutsch

Vk_20110506_04
23.05.2011 AirOX S.A.

LEGENDAIR
Model 4095700, 4095701, 4095702, 4095705, 4095706, 4095709, 4095900, 4095901, 4095902, 4095905, 44095906, 4095909, 4095921
S/N: all

MD: Ventilator, home-use

Deutsch

English

Vk_20110517_02
23.05.2011 Varian Medical Systems Inc

Optical Guidance Platform (OGP)
Model HZ1
Lot: See attached FSN

MD: Stereotactic-radiosurgical linear accelerator system

Deutsch

Français

Italiano

English

Vk_20110520_03
23.05.2011 American Medical Systems Inc.

Elevate Pelvic Floor Repair Systems with IntePro Lite
Model 720093-01
S/N: 669204 to 694747

MD: Mesh, surgical

Deutsch

Vk_20110520_02
23.05.2011 Smith & Nephew Inc.

R3 Ceramic Acetabular Liners
Model 71331648, 71331650, 71331652, 71331654, 71331656, 71331662
Lot: 09KT36252, 10DT41428, lOFT43676, and 10FT43679, 09JT35943, lOCT40613, 10DT41486, 10FT43294, and 10FT43611, 09HT34970, 09HT34971, 09JT35865, 10DT41337, 10FT43295, 10FT43677, and 10FT43680, 09KT35979, 10DT41487, and 10DT41736, 09KT36324, 10DT41489, and 10F

MD: Acetabulum prosthesis

English1

English2

Vk_20110308_08
16.05.2011 DiaMed GmbH

Update

IH-1000 analyzer in combination with ID-DiaClon Anti-D

IVD: Blood grouping system, automated

English

Update English

Vk_20110426_08
16.05.2011 Maquet Critical Care AB

SERVO-S
Model 66 40 440
S/N: all

 

Servo-i
Model 64 87 800
S/N: all

MD: Intensive care ventilator

English

Vk_20110511_02
16.05.2011 B. Braun Melsungen AG

Intrafix Primeline
Model 4062981L
Lot: 1B09018431

MD: Infusion pump administration set

Deutsch

Français

Italiano

Vk_20110512_05
16.05.2011 Smiths Medical ASD, Inc.

Level 1® Normothermic I.V. Fluid Administration Sets
Model DI-60HL, DI-50, and DI-100
Lot: all

MD: Intravenous administration set, heat-exchanging

Deutsch

Français

Vk_20110511_03
16.05.2011 Medtronic Ablation Frontiers LLC

GENius Multi-Channel RF generator
Model 990018
Software Version: 12.2, 14.0-14.4

 

GENius Multi-Channel RF generator
Model 990018
Software Version: 11

MD: Cardiac tissue ablation system

Deutsch

Français

English

Vk_20110510_03
16.05.2011 Edwards Lifesciences LLC

NovaFlex Delivery System
Model 9350FS23, 9350F26
Lot: All lot numbers with a use by date up to and including 2011-08

MD: Vascular stent-placement catheter

Deutsch

Français

English

Vk_20110510_01
16.05.2011 Integra LifeSciences (Ireland) Ltd.

CUSA NXT Service Module
Model CUSANXT2
S/N: NXT1022

MD: Electromechanical device transport trolley

English

Vk_20110512_11
16.05.2011 Haag-Streit AG

Instrument table IT 01 for Perimeter Octopus 300
Model 7220034
S/N: 1 to 5

 

Instrument table IT 02 for Perimeter Octopus 900
Model 7220004
S/N: 1 to 49

MD: Ophthalmic table, line-powered

Deutsch

English

Vk_20110511_01
16.05.2011 Ormco Corporation

TMA Archwires
Model 211-1402
Lot: 10K291

MD: Orthodontic archwire

Deutsch

English

Vk_20110503_12
16.05.2011 Haemonetics Corporation

orthoPAT
Model 1050-240-XXX, 1050-240-ENG, 1050-240-SPN, 1050-240-ITL, 1050-240-GER, 1050-240-DUT, 1050-240-FRN, 1050-240-CZE
S/N: all

MD: Blood-processing autotransfusion system

Deutsch

Français

Italiano

English

Vk_20110510_02
16.05.2011 Beckman Coulter Inc.

COULTER LH 500 Hematology Analyzer

 

COULTER LH 750 Hematology Analyzer

 

COULTER GEN*S SlideMaker

 

COULTER LH 780 Hematology Analyzer

IVD: Haematology analyser, cell-differential; Haematology analyser

Deutsch

English

Vk_20110307_03
09.05.2011 Swissimplant AG

Update

Solysafe Septal Occluder
Model:
Type 15 - REF 010.0001
Type 20 - REF 010.0002
Type 25 - REF 010.0003
Type 30 - REF 010.0004
Type 35 - REF 010.0005
Lot: All

MD: Cardiac occluder

Update Deutsch

Update Français

Update Italiano

Update English

Vk_20100806_01
09.05.2011 Weinmann GmbH + Co

Meducore Easy defibrillator
Model WM 4xxxx
S/N: All

MD: Automatic external defibrillator

Deutsch

Français

English

Vk_20110428_05
09.05.2011 Philips Healtcare

PercuNav Field Generator Stand
Model 453561431911

MD: System, x-ray, tomography, computed

Français

English

Vk_20110504_05
09.05.2011 Thermo Fisher Scientific Microbiology Basingstoke

O.B.I.S. Salmonella 60 Tests
Model ID0570M
Lot: 941561

IVD: Culture medium supplement, enriched

English

Vk_20110504_01
09.05.2011 Zimmer Spine

Sequoia Final Driver Closure Top Retention
Model 3384-2

MD: Surgical procedure kit

English

Update English

Vk_20110420_10
09.05.2011 Boston Scientific

Pinnacle Pelvic Floor Repair Kit
Model M0068317050
Lot: ML00000034

 

AccuMax 365 Single-Use Holmium Laser Fiber
Model M0068404020
Lot: ML00000061

 

Resolution II
Model M00522502, M00522511, M00522512
Lot: ML00000042; ML00000043, ML00000040

 

Advantage System
Model M0068502000; M006850200051, M0068502111
Lot: ML00000035, ML00000036; ML00000038

 

Resolution Clip
Model M00522610; M00522611; M00522611; M00522612
Lot: ML000019C2; ML000017C2; ML000018C2; ML000020C2

MD: Surgical mesh kit; Laser beam delivery unit, fibreoptic; Ligation clip, metallic

Deutsch

Français

Italiano

English

Vk_20110506_01
09.05.2011 Hitachi Medical Corporation

Ultrasound scanner HI VISION
Model Ascendus, Preirus, Avius
S/N: on demand
Software Version: V03-00, V03-02, V03-30, V03-33

MD: Scanner, ultrasonic

English

Vk_20110503_07
09.05.2011 bioMérieux Inc.

VITEK 2 Piperacillin/Tazobactam Test

IVD: Culture medium, antimicrobial susceptibility test

Deutsch

Français

Vk_20110504_08
09.05.2011 Vital Signs Inc.

Infusable & InfusaScan Pressure Infusor
Model IN800012, IN800020, IN800048, IN900012 , IN900020, IN900048, IN950006, IN950012

MD: Pressure infusor, manual

Deutsch

Français

Italiano

English

Vk_20110503_05
09.05.2011 GE Healthcare Finland Oy

CARESCAPE Monitor B850
Software Version: 1.0.6 and previous

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

Deutsch

Français

Italiano

Vk_20110503_08
09.05.2011 Sorin CRM S.r.l

Paradym
Model VR 8250, DR 8550, CRT-D 8750 and CRT-D 8770; CRT-D 8770 included in clinical studies (Clepsydra)

AIMD: Dual-chamber implantable defibrillator

Deutsch

Français

Italiano

Vk_20110505_06
09.05.2011 Varian Medical Systems Inc

Optical Guidance Platform (OGP)
Model HZ1
Software Version: 2.6, 2.6.1

MD: Stereotactic-radiosurgical linear accelerator system

Deutsch

Français

Italiano

English

Vk_20110505_07
09.05.2011 GE Healthcare Finland Oy

Carescape B650
S/N: See attachment
Software Version: 1.1.6 and previous

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

Deutsch

Français

Italiano

Vk_20110503_09
09.05.2011 Coloplast A/S

Easicath coated urinary catheter Female CH12
Model 05372
S/N: 2632521

MD: Urethral catheter, drainage, single-administration

Deutsch

English

Vk_20110420_18
09.05.2011 Sorin CRM

Programmer for Reply / Esprit pacemakers
Software Version: 2.24

AIMD: Pacemaker programmer

Deutsch

Français

Italiano

Vk_20110503_04
09.05.2011 Siemens Healthcare Diagnostics Products GmbH

N Latex Free Light Chain lambda
Model OPJB03

IVD: Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry

Français

English

Vk_20110504_10
02.05.2011 Philips Medical Systems

S8-3t Micro Transducer
Model S8-3t
S/N: See list

MD: General-purpose ultrasound imaging system

Deutsch

English

Vk_20110428_02
02.05.2011 GE Hangwei Medical Systems Co.; GE Medical Systems LLC; GE Healthcare Japan Corporation

Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant
Software Version: All SR Viewer versions 2.4.1 and 2.6.13 on the MR console

 

Optima MR360, Brivo MR355
Software Version: All SR Viewer versions 2.4.1 and 2.6.13 on the MR console

 

GE 1.5T Signa HDe
Software Version: All SR Viewer versions 2.4.1 and 2.6.13 on the MR console

MD: MRI system, full-body

Deutsch

Français

Italiano

Vk_20110427_01
02.05.2011 Coloplast A/S

Easicath coated urinary catheter Female CH12
Model 05372
S/N: 2632521

MD: Urethral catheter, drainage, single-administration

Deutsch

English

Vk_20110420_18
02.05.2011 Zimmer GmbH

Avenir Mueller Stem system
Model 01.06010.105, 01.06010.005
Lot: Lot no. 4016118 (ref. 01.06010.105) manufactured 05.10 .2010, Lot no. 4016167 (ref. 01.06010.005) manufactured 29.09.2010

MD: Hip prosthesis, internal, femoral component

Deutsch

Français

Italiano

English

Vk_20110426_01
02.05.2011 Paradigm Spine GmbH

DCI Dynamisches Halswirbelsäulenimplantat
Model CBI14166, CBI14165
Lot: 2009501726 (CBI14166), 2009501725 (CBI14165)

MD: Orthopaedic internal fixation system, plate/screw, non-biodegradable

Deutsch

Vk_20110419_17
02.05.2011 Link Waldemar GmbH & Co

LINK Endo-Model Tibial Plateau metal-backed
Model 12-2030/06 to 15-2030/12

MD: Prostheses, joint, knee, tibial component

Deutsch

English

Vk_20110426_05
02.05.2011 Beckman Coulter Inc.

COULTER Ac * TTM 5diff Autoloader (AL) Hematology Analyzer
Model PN: 175356

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

Deutsch

Français

English

Vk_20110411_01
02.05.2011 Mölnlicke Health Care Group

Biogel surgical glove

MD: Hevea-latex surgical glove, non-powdered

Deutsch

Français

Italiano

Vk_20110428_03
26.04.2011 Teleflex Medical Sdn. Bhd.

CrystalClear Tracheostomy tube cuffed & CrystalClear PDT
Model 121610, 858510,121502,121556
Lot: See list

MD: Basic tracheostomy tube, single-use

Deutsch

English

Vk_20110420_16
26.04.2011 B. Braun Vascular Systems

Arteriofix V
Model 5206361, 5206362, 5206363, 5206364
Lot: 09C23844, 09L18844

MD: Arterial blood pressure catheter

English

Vk_20110419_04
26.04.2011 BD Becton Dickinson

Venflon
Model 391451
Lot: 10F2941E

MD: Peripheral vascular catheter, infusion

Deutsch

English

Vk_20110419_15
26.04.2011 EOS imaging

EOS system, SterEos workstation, X-ray system
Software Version: see list

MD: Stationary basic diagnostic x-ray system, digital

Français

English

Vk_20110420_06
26.04.2011 Varian Medical Systems Inc

Clinac Linear Accelerator
Model H14, H18, H27, H29

MD: Linear accelerator system

Deutsch

Français

Italiano

English

Vk_20110419_02
26.04.2011 TMS International BV

Reaf8
Lot: 108070011

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

Deutsch

Français

English

Vk_20110420_07
26.04.2011 Roche Molecular Systems Inc.

Cobas Ampliprep/Cobas TaqMan HCV Test
Model 03568547190
S/N: all
Lot: all

IVD: Hepatitis C virus total antibody kit

Deutsch

Français

English

Vk_20110419_18
26.04.2011 Beckman Coulter Inc.

ACCESS TT4
Model PN: 33800

IVD: Thyroxine kit

Deutsch

Français

English

Vk_20110420_12
26.04.2011 Smith & Nephew, Inc.

Twinfix Ultra Ti 5.5mm Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-BLACK)
Model 72202897
S/N: 50358739

MD: Ligament anchor

Deutsch

Vk_20110420_08
26.04.2011 DePuyFrance SAS

Corail Revision Hip System
Lot: L98408 to L98416, L98418 and L98420

MD: Orthopaedic prosthesis implantation instrument

Deutsch

Français

English

Vk_20110420_14
26.04.2011 Evalve, Inc., Abbott Vascular

MitraClip Mitral Valve Repair System
MSK02ST kit consisting of: CDS02ST, SGC01ST

MD: Mitral valve tissue repair system

Deutsch

Italiano

English

Vk_20110426_02
18.04.2011 DePuy Spine Inc.

Confidence 11g x 6-inch Introducer Needle, Diamond Tip
Model 283903611
Lot: HLPB4G

 

Confidence 13g x 4-inch Introducer Needle, Side Hole
Model 283904413
Lot: HLPB4F

MD: Needle introducer

English

Vk_20110413_09
18.04.2011 Therakos, Inc.

Therakos UVAR XTS Photopheresis System Procedural Kits
Lot: see letter

MD: Photopheresis system

English

Vk_20110412_04
18.04.2011 Philips Medical Systems

Vitaline H Set Infant/Neo
Model 989803159581
Lot: M8409P10

 

Filterline H Set Infant/Neo
Model M1923A
Lot: M8330M10, M8386N10, M8411P10, M8451P10, M8477A11M8514A11, M8572B11

MD: Low pressure compressed medical gas tubing

English

Vk_20110412_02
18.04.2011 Ziehm Imaging GmbH

Ziehm C-Arm
Model 8000, Compact, Solo, Vision, Vision FD, Vision FDVario 3D, Vision RFD, Vision R, Vision Vario 3D and Vista plus

MD: Fluoroscopic x-ray system, general-purpose, hand-held, analogue

English

Vk_20110412_01
18.04.2011 Waters Corporation

Waters IEE detectors
Model 2410, 2414, 2487, 2996, 996, 486, 410
Lot: See letter
Software Version: Empower2FR5, Empower 3, Breeze 2

IVD: Instruments and supporting software

Deutsch

Français

Italiano

English

Vk_20110414_04
18.04.2011 Nihon Kohden Corp.

cardioLife
Model AED-2100K
S/N: up to 04440

MD: Defibrillation/physiologic monitoring system

Deutsch

English

Vk_20110407_07
18.04.2011 B.Braun Medical Division Aesculap

Tempofilter II
Model 4430098
S/N: all
Lot: all

MD: Vena cava filter, temporary/permanent

English

Vk_20110412_03
18.04.2011 Varian Medical Systems Inc

Clinac Linear Accelerator
Model H14, H18, H27, H29, HCX
S/N: See list

MD: Linear accelerator system

Deutsch

Français

Italiano

English

Vk_20110414_03
18.04.2011 Defibtech, LLC

DDU-100 Series AED, Lifeline/Lifeforce AED
Model DDU-100
Software Version: 2.004 or earlier

MD: Semi-automated external defibrillator

Deutsch

Français

Italiano

English

Vk_20110407_02
18.04.2011 Medion Grifols Diagnostics AG

Control set
Model ref 213396
Lot: 635511003

IVD: Immunohaematology control kit

Deutsch

English

Vk_20110412_13
11.04.2011 Hospira Inc.

Plum A + Infusionsspumpen
Model see letter
S/N: see letter

MD: General-purpose infusion pump

Deutsch

English

Vk_20110407_06
11.04.2011 Ethicon Inc.

BLAKE Silicone Drain
Model 2210, 2211, 2212, 2213, 2214, 2215, 2216, 2217, 2226, 2227, 2228, 2229, 2230, 2231, 2232, 2234,
Lot: see letter

 

J-VAC Drain Adapter
Lot: see letter

 

J-VAC Reservoir
Model 2160
Lot: see letter

 

BLAKE Cardio Connector
Model BCC1, BCC2, BCC3
Lot: see letter

 

BLAKE Silicone Drain Kit
Lot: see letter

MD: Closed-wound drainage kit
Closed-wound drain
Closed-wound drainage reservoir

Deutsch

Français

English

Vk_20110405_10
11.04.2011 Möller Medical GmbH

Trauma Needle Kit, 3.3mm, Cannula w/side-open
Model 03.702.120S
S/N: AIM819X, AIM318S, AHZ980, AHZ955

MD: Orthopaedic cement preparation/delivery kit

English

Vk_20110405_03
11.04.2011 Hermann Bock GmbH

Care bed
Model domiflex, eloflex, practico, ancona
S/N: all with date of delivery: 26.02.2009 - 28.07.2009

MD: Bed, electric

Deutsch

English

Vk_20110323_13
11.04.2011 Philips Medical Systems

IntelliVue Clinical Information Portfolio (ICIP)
Model 865047, 865209, 865300
Software Version: D.03, E.0, E.01

MD: Data management system, patient

Deutsch

Vk_20110405_07
11.04.2011 Ranier Technology Limited

Cadisc-L Compliant Artificial Lumbar Disc Replacement Device
Model 130-S-10-09-02; 130-S-10-12-03; 130-M-I0-06-07; 130-M-IO-09-08; 130-M-I0-12-09; 130-L-IO-06-13; 130-L-IO-09-14; J30-L-IO-12-15
Lot: See letter

MD: Artificial lumbar disc replacement device

English

Vk_20110407_01
11.04.2011 Medtronic Xomed

Thermasplints Kit
Model 1529100 (small); 1529110 (medium); 1529120 (large)
Lot: all lots since January 2008

 

External Nasal Splint Kit
Model 1528116 (small); 1528126 (medium); 1528136 (large)
Lot: all lots since January 2008

MD: Nasal splint, external

Deutsch

Français

Italian

Vk_20110331_05
11.04.2011 Maquet GmbH & Co. KG

1180.16 Magnus Carbon-Fibre Table Top
Model see letter
S/N: see letter

MD: Table, operating

Deutsch

English

Vk_20110405_14
11.04.2011 Medtronic Inc.

Adapta, Versa, Sensia, EnPulse, Kappa 600, 700, 800, 900
Model Various
S/N: All
Lot: All

AIMD: Pacemaker, implantable

Deutsch

Italien

Vk_20110407_03
04.04.2011 Philips Healthcare Informatics, Inc.

iSite PACS with iSite AVT / iSite ViewForum Applications
Software Version: iSite v3.6.87, v3.6.92, v3.6.96, v3.6.101, v3.6.110, v4.1.87, v4.1.92, v4.1.96, v4.1.101, v4.1.110; iSite AVT / iSite ViewForum R7.4V6 L1 L2, L3

MD: Picture archiving and communication systems (PACS), radiology

Deutsch

Italiano

English

Vk_20110329_08
04.04.2011 Medtronic Inc

UPDATE

Sprint Fidelis Lead Family
Model 6949, 6931, 6948, 6930

AIMD: Electrode/lead, defibrillator, implantable

Deutsch

Français

Italiano

English

Vk_20071016_01
04.04.2011 Varian Medical Systems Inc

Clinac Linear Accelerator
Model H14, H18, H29, H27

MD: Linear accelerator system

Deutsch

Français

English

Vk_20101203_05
04.04.2011 Codman & Shurtleff, Inc

Codman Hakim Programmable Valve (Inline)
Model 82-3164
Lot: CLNCGH

 

Codman Hakim Programmable Valve (Rt. Angle w/Siphon Guard)
Model 82-3182
Lot: CLLCV1

 

Hakim Programmable Valve (MICRO)
Model 82-3097
Lot: CLNCG4

 

Codman BACTISEAL Catheter Kit
Model 82-3072
Lot: CLNC3T

 

ACCU-FLO CSF Reservoir
Model 82-6100
Lot: CLMCT9

 

Codman External Drainage System 3
Model 82-1731
Lot: CLNB12

 

HOLTER RICKHAM Reservoir (SS Base)
Model 82-1615
Lot: CLMCT9

 

HOLTER RICKHAM Reservoir (Plastic Base)
Model 82-1616
Lot: CLNBB5, CLNC0Y

 

MEDSTREAM Bolus Kit
Model 91-4284
Lot: CKKCDW

 

Micro programmable Valve with integral Conn.

MD: Hydrocephalic valve
Intracranial ventricle catheter
Cerebrospinal fluid reservoir
General-purpose implantable infusion pump, programmable

English

Vk_20110331_06
04.04.2011 Given Imaging, Ltd.

PillCam Express Delivery Device
Model FGS-0366 and FGS-0377
Lot: FGS-0366: 14081, 13688, 14097,14144, 13783, 13504FGS-0367: 13438, 13690, 137,81, 138,06, 14082, 14095, 14099,14145, 14249, 14370, 14568, 14508, 14787

MD: Express Delivery Device

Deutsch

Français

English

Vk_20110331_03
04.04.2011 Zimmer, Inc.

NEXGEN Complete Knee Solution quick-connect handle
Model 00-5901-034-00
Lot: see letter

 

NEXGEN Complete Knee Solution Posterior Referencing sizer
Model 00-5901-040-00
Lot: see letter

 

NEXGEN Complete Knee Solution Distal Femoral Resection Guide
Model 00-5901-063-00
Lot: see letter

 

NEXGEN Complete Knee Solution Femoral Valgus Alignment Guide
Model 00-5901-067-00
Lot: see letter

 

NEXGEN Complete Knee Solution Extramedullary Distal Telescoping Tube
Model 00-5901-071-00
Lot: see letter

 

NEXGEN Complete Knee Solution Patella Clamp
Model 00-5903-020-00
Lot: see letter

 

NEXGEN Complete Knee Solution Patella Peg Drill Guide Handle
Model 00-5903-060-00
Lot: see letter

 

NEXGEN Complete Knee Solution Posterior Referencing Sizer Boom
Model 00-5901-040-10
Lot: see letter

 

NEXGEN Complete Knee Solution Extramedullary Modular Spike Arm Post, Model 00-5901-074-00
Lot: see letter

 

NEXGEN Complete Knee Solution Modular T-Handle
Model 00-5901-061-00
Lot: see letter

 

NEXGEN Complete Knee Solution Femoral And Provisional Impactor/Extractor
Model 00-5901-026-00
Lot: see letter

 

NEXGEN Complete Knee Solution Extramedullary Proximal Telescoping Rod
Model 00-5901-072-00
Lot: see letter

 

NEXGEN Complete Knee Solution Patella Osteotomy Guide
Model 00-5903-010-00
Lot: see letter

MD: Orthopaedic prosthesis implantation instrument

English

Vk_20110329_09
04.04.2011 Becton Dickinson and Company Ltd, Ireland

Microlance Hypodermic Needle, sterile
Model 30400
Lot: 101213, 100920, 100916, 100612, 100609, 100304, 100224, 100211, 091113, 091112

 

Plastipak Syringe with 30G Microlance Needle
Model 300334
Lot: 1011040, 1011036, 1009020,1005003

 

Microlance Hypodermic Needle, Non Sterile
Model 300392
Lot: 0271553, 0258005, 0153304

MD: Hypodermic needle, single-use; Insulin syringe

Deutsch

Français

Vk_20110225_01
04.04.2011 Datascope Corp.

Intra-Aortic Balloon Pump
Model System 98, 98XT, CS100, CS100i, CS300
S/N: See list

MD: Intra-aortic balloon circulatory assist system

English

Vk_20110331_04
04.04.2011 Berlin Heart GmbH

INCOR

AIMD: Ventricular circulatory assist system

Deutsch

Vk_20110330_03
04.04.2011 Molift AS

Molift Smart 150
Model 0920008
S/N: from 20941 to 27299

MD: Mobile patient lifting system, battery-powered

Deutsch

Français

Italiano

Vk_20110330_17
04.04.2011 Zimmer, Inc.

NEXGEN Complete Knee Solution Femoral And Provisional Impactor/Extractor
Model 00-5901-026-00
Lot: all lots

 

NEXGEN Complete Knee Solution Replacement Jaw for use with Femoral and Provisional Impacto/extractor
Model 00-5901-026-40
Lot: all lots

MD: Orthopaedic prosthesis implantation instrument

English

Vk_20110329_11
04.04.2011 Agfa Healthcare N.V.

NX - Modality Workstation (s/w)
Software Version: 2.0.8100 / 3.0.8100 / 2.0.8200 / 3.0.8200 / 2.0.8300 / 3.0.8300 / 2.0.8400 / 3.0.8400 / 2.0.8500 / 3.0.8500

MD: Basic diagnostic x-ray system application software

Deutsch

Français

Italiano

Vk_20110331_02
04.04.2011 Philips and Neusoft Medical Systems Co., Ltd.

MX 16-slice
Model MX-16-slice

MD: Full-body CT system

English

Vk_20110331_10
04.04.2011 WaveLight AG

WaveLight EX500
Model 1016

MD: Ophthalmic excimer laser system

Deutsch

Français

Vk_20110329_01
04.04.2011 Kern & Sohn GmbH

Kern Lifter scales300K100M

MD: Scale

English

Vk_20110331_11
28.03.2011 Varian Medical Systems Inc

ARIA Radiation Oncology
Model HIT
S/N: See List
Software Version: 8.0 and 8.1

MD: Radiology information system

Deutsch

Français

English

Vk_20110224_04
28.03.2011 Baxter Healthcare SA

Single Day INFUSOR System
Model 2C1071KJP/ 2C1073KJP
Lot: 10H064

MD: Elastomeric infusion pump system

English

Vk_20110323_06
28.03.2011 GE Medical Systems

CARESCAPE Monitor B850
Model see letter
Software Version: 1.0.5 and earlier

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

Deutsch

Français

Italiano

Vk_20110323_05
28.03.2011 Sysmex Corporation

Sysmex CS-2x00i Series Analysers

IVD: Haematology analyser, coagulation

Deutsch

Update Deutsch

Français

Update Français

Vk_20110323_01
28.03.2011 Hill-Rom SAS

Avantguard 1200 LI158
Model 158A and 158B
S/N: HRP001371571 through HRP001490216

MD: Basic electric hospital bed

English

Vk_20110323_03
28.03.2011 B. Braun Melsungen AG

Omniflush Saline
Model 3570220 / 3570230 / 3570250 / 3570260
Lot: S10124 / S10126 / S10192 / S10270 / S10271 / S10273 / S10274 / S10337 / S10338 / S10340 / S10342 / S10344 / S10346 / S10349 / S10351

MD: Surgical/medical procedure irrigation fluid

Deutsch

Français

Italiano

Vk_20110323_04
28.03.2011 Synthes GmbH

Titanium MATRIX Locking Cap
Model 04.632.000
Lot: All lot numbers

MD: Bone-screw internal spinal fixation system

English

Vk_20110322_01
28.03.2011 Smith & Nephew Inc.

TWINFIX Ti 3.5mm Suture Anchor with two preloaded DURABRAID sutures with needles
Model 7210302
Lot: 50325616, 50327209, 50329816

MD: Surgical binding material anchor set

Deutsch

Vk_20110322_04
28.03.2011 Becton Dickinson and Company Ltd, Ireland

Microlance Hypodermic Needle, sterile
Model 30400
Lot: 101213, 100920, 100916, 100612, 100609, 100304, 100224, 100211, 091113, 091112

 

Plastipak Syringe with 30G Microlance Needle
Model 300334
Lot: 1011040, 1011036, 1009020,1005003

 

Microlance Hypodermic Needle, Non Sterile
Model 300392
Lot: 0271553, 0258005, 0153304

MD: Hypodermic needle, single-use & Insulin syringe

Deutsch

Français

Vk_20110225_01
21.03.2011 Elekta Limited

XVI Digital imager
Software Version: R4.5

MD: Digital imager, radiation therapy

Français

English

Vk_20110317_04
21.03.2011 Draeger Medical Schweiz AG, PanGas

Pin-Index Buegel fuer Sauerstoff
Model BR 20-xxx und BJ 510-xxx

MD: Medical gas cylinder regulator

Deutsch

Français

Italiano

Vk_20100205_02
21.03.2011 Synthes GmbH

PlivioPore, Osteoconductive Titan Structure
Model 495.037S, 495.039S, 495.040S, 495.041S, 495.042S, 495.043S, 495.045S
Lot: See List in customer letter

MD: Osteoinduction filler, specify

Deutsch

Français

English

Vk_20110315_04
21.03.2011 Terumo Cardiovascular Systems

Terumo Advanced Perfusion System 1:

Occluder Module
Model 802110
S/N: 01198, 01205-01241, 01243-01281, 01283-01399, 01401-01404, 01406-01422, 01424-01433, 01435-01554, 01556-01563, 01565-01581, 01583-01609, 01611, 01613-01660,01662-01721, 01724-01725

 

Air Bubble Detector Module
Model 803480
S/N: 00632-00635, 00638, 00642- 00711, 00713-00715, 00717-00741, 00752-00813, 00815-00821, 00823-00864, 00867, 00869-00874

MD: Cardiopulmonary bypass system mounting unit, Cardiopulmonary bypass system air bubble/fluid level detector

Français

English

Vk_20110318_02
21.03.2011 PulseCath BV

PulseCath iVAC3L (21 Fr)
Model LV21
Lot: LV21AL02 , LV21AL03, LV21AL04, LV21AL05, LV21AM01, LV21AM02, LV21AM03, LV21AN01, LV21AN02, LV21AN03, LV21AO01, LV21AO02

MD: Circulatory assist pump

Deutsch

Français

Italiano

English

Vk_20110317_05
21.03.2011 Penumbra, Inc.

Penumbra Coil 400
Lot: 18553 and lower (see letter)

MD: Neurovascular embolization implant

English

Vk_20110316_02
21.03.2011 Instrumentation Laboratory Co.

GEM Premier 4000
Software Version: 2.1.1 or below

IVD: Blood gas analyser

Deutsch

Français

English

Vk_20110316_01
14.03.2011 DePuy MITEK Inc.

Gryphon P BR Anchor w/ Orthocord
Model 210814
Lot: 3450116, 3452126, 3452666, 3455577, 456320, 3459759, 3463735, 3464069

 

Gryphon T BR Anchorw/ Orthocord
Model 210812
Lot: 3409863, 3415962, 3416197, 3416462, 3417102

 

Gryphon P BR OS Anchor w/ Orthocord
Model 210813
Lot: 3449990, 3451672, 3452663, 3453946, 3455144, 3455703, 3456883, 3462226

 

Gryphon T BR DS Anchorw/ Orthocord
Model 210811
Lot: 3411147, 3415167, 3415244, 3417101, 3418587

MD: Soft-tissue anchor, biodegradable

Deutsch

Français

Italiano

English

Vk_20110310_03
14.03.2011 Beckman Coulter Inc.

UniCel DxH 800 Coulter Cellular Analysis System
Model 629029
S/N: all
Software Version: 1.1.3.1

IVD: Haematological cell analyser IVD, automated

Deutsch

Français

English

Vk_20110309_01
14.03.2011 Imtmedical AG

Bellavista 1000 ventilator
Model 1000
S/N: MB100015 - MB100149

MD: Intensive-care ventilator, adult/infant

English

Vk_20110308_02
14.03.2011 Alcon Laboratories Inc.

Alcon Custom Pak
Model see letter
Lot: see letter

MD: Non-medicated ophthalmic surgical procedure kit, single-use

Deutsch

Français

English

Vk_20110308_17
14.03.2011 Penlon Ltd.

Crystal Metal Miller Disposable Blade
Model sizes 00 and 01
Lot: Batches with expiry dates between August 2010 to July 2015

MD: Laryngoscope blade, single-use

English

Vk_20110311_01
14.03.2011 Mölnlycke Health Care AB

Mölnlycke Health Care Procedure Pak, Grund - Set Dermatologie
Model 97025370-02
Lot: 10337852, 10231154, 10131596, 10439392, 11049216

 

Mölnlycke Health Care Procedure Pak, M-Set AMO
Model 97029111-01
Lot: 10352976

MD: Non-medicated general surgical procedure kit, single-use; Non-medicated ophthalmic surgical procedure kit, single-use

Deutsch

Français

Italiano

English

Vk_20110308_16
14.03.2011 Codan Argus AG

Argus A606 S TIVA
Model 601100 (16.0010) /601 126 (16.0000)
Software Version: 4.63

MD: syringe pump target-controled-infusion control unit

Deutsch

English

Vk_20110308_03
14.03.2011 Laboratoires FILORGA

M-HA18
Lot: 403008/1; 403007/4; 403007/3; 403007/2

MD: injectable volumizing filler formulated with highly cross-linked hyaluronic acid

Français

English

Vk_20110308_15
14.03.2011 Beckman Coulter Inc.

Access Thyroglobulin Antibody II Reagent

IVD: Thyroglobulin autoantibody kit

English

Vk_20110307_02
14.03.2011 Maquet Cardiopulmonary AG

CARDIOHELP Emergency Drive
S/N: S/N 90420011 to S/N 90420246

MD: Cardiopulmonary bypass system, roller type

English

Vk_20110308_01
14.03.2011 Beckman Coulter Inc.

Coulter PrepPlus 2
Model PN: 378600
Software Version: 2.02/2.03

IVD: Sample processing system

Français

English

Vk_20110304_04
14.03.2011 Siemens AG

Axiom Aristos FX
Model 7414803
S/N: up to and including serial number 1216

 

Axiom Aristos FX Plus
Model 10093864
S/N: up to and including serial number 1216

MD: Stationary basic diagnostic x-ray system, digital

Deutsch

Français

Vk_20110309_02
07.03.2011 Sixtem Life Srl

Verrukill
Lot: DD0051 und DG0055

MD: Cryogenic spray, cutaneous

Deutsch

Français

Italiano

Vk_20110222_06
07.03.2011 Thermo Fisher Scientific Microbiology Basinastoke

Oxoid XLD Medium
Model CM0469
S/N: 992444

IVD: Culture medium supplement, enriched

English

Vk_20110303_02
07.03.2011 Beckman Coulter Inc.

Access HAV Ab Reagent
Model 34200
Lot: 094058

IVD: Hepatitis A virus total antibody kit

Deutsch

English

Vk_20110304_02
07.03.2011 HemoCue AB

HemoCue Glucose 201 RT, HemoCue Glucose 201 DM RT

IVD: Glucose analyser, laboratory

English

Deutsch

Vk_20110303_04
07.03.2011 Fresenius Kabi AG

AppIix smart
Model 7751901
S/N: from 1998xxxx to 2010xxx
Software Version: Revision <5.1J

 

Applix vision
Model 7751801
S/N: from 1998xxxx to 2010xxx
Software Version: Revision <5.1J

MD: Enteral feeding pump

Deutsch

Deutsch2

Français

Italiano

Vk_20110301_06
07.03.2011 PIERRE FABRE DERMO-COSMETIQUE

Glytone professional 2
Model 642107
Lot: P00026A, P00029, P00032, P00033, P00034, P00035,P00036,POOO37,POO038 et POO041

MD: Synthetic-fluid tissue reconstructive material

English

Vk_20110301_10
07.03.2011 Philips Medical Systems

HeartStart MRx
Model M3535A; M3536A
S/N: see list

MD: Defibrillator/monitor

Deutsch

Français

English

Italiano

Vk_20110301_11
07.03.2011 GE Healthcare Finland Oy

TruSat Oximeters and Accessories
Model see letter
S/N: see letter

MD: Pulse oximeter, line-powered

Deutsch

Français

Italiano

Vk_20110301_14
07.03.2011 DiaSorin S.p.A.

fT3-CTK
Model 230-100
Lot: 1230001

IVD: Free triiodothyronine kit

Italiano

English

Vk_20110304_01
07.03.2011 Roche Diagnostics GmbH

Calcium (COBAS INTEGRA, cobas c 311/501/502/711)
Model 20763128 322, 04932650 022
Lot: 630204-01, 631376-01

IVD: Calcium kit

English

Deutsch

Français

Vk_20110303_03
07.03.2011 Medion Grifols Diagnostics AG

Screen-Cyte 3%
Model 213385 (070160)
Lot: 601011001

IVD: Antibody 3 cell screening kit

Deutsch

Français

English

Vk_20110301_01
07.03.2011 Beckman Coulter Inc.

UniCel DxI 800 Access Immunoassay System
Model See attachment
Software Version: See attachment

 

UniCel DxC 660i, 680i, 860i, 880i Synchron Access Clinical Systems
Model See attachment
Software Version: See attachment

 

UniCel DxI 600 Access Immunoassay System
Model See attachment
Software Version: See attachment

IVD: Immunoassay analyser

Deutsch

Français

English

Vk_20110302_03
07.03.2011 Vital Signs Inc.

Green Light II Laryngoscope Handle
Model 4558 GSP
Lot: 5128F, 5139M, 5140P, 5144A, 5154Y, 5180Z, 5184U, 5191X

 

Green Light II Battery Cartridge
Model 4559 LED
Lot: 5137P, 5161J, 5183L

MD: Laryngoscope

Deutsch

Français

Vk_20110301_08
07.03.2011 Siemens Healthcare Diagnostics AG

Von Willerbrand Factor Reagent
Model OUBD 23
Lot: 506510

IVD: Coagulation factor von Willebrand kit

Français

English

Vk_20110303_01
07.03.2011 Stryker Orthopaedics

Triathlon PKR Instruments, Peg Drill
Model 5650-4-512, 5650-4-536
S/N: All
Lot: All

MD: Trial joint prosthesis

Deutsch

Vk_20110216_01
07.03.2011 Medion Grifols Diagnostics AG

Control Set
Model 213396 (070174)
Lot: 635511001

IVD: Immunohaematology control kit

Deutsch

English

Vk_20110301_02
07.03.2011 Biomet UK Ltd

Vanguard Microplasty Slidex AP Sizer
Model 32-485050
S/N: SA1081254

MD: Sizer

English

Vk_20110301_13
07.03.2011 Smiths Medical ASD, Inc.

Level 1® Normothermic I.V. Fluid Administration Sets
Model DI-65HL, DI-75, DI-150

MD: Intravenous administration set, heat-exchanging

Deutsch

Français

Italiano

English

Vk_20110301_07
28.02.2011 Smith & Nephew, Inc.

Clear-Trac Flexible Reusable Obturator
Model 72200899, 72200899F, 72200900, 72200900F, 72201796, 72201796F

MD: Endoscope element, obturator

Deutsch

Vk_20110216_15
28.02.2011 Alere San Diego, Inc

Cholestech LDX Lipid Profile GLU test cassettes
Model 10-991
Lot: 245104

IVD: Glucose kit

Deutsch

Français

Italiano

English

Vk_20110223_01
28.02.2011 Intersurgical Ltd

IS-Can C02-Absorber
Model 2196000
Lot: 1110005 oder kleiner

MD: Anaesthesia absorber

Deutsch 1

Deutsch 2

Vk_20110222_04
28.02.2011 Sunrise Medical GmbH

Neon Swing Away Wheelchairs
Model 054000.01, 054001.01, 054000.01M, 054000.01N, 055000, SB054000.01, SB054001.01,SB055000

MD: Wheelchair

Deutsch

Français

English

Vk_20110224_05
28.02.2011 Roche Diabetes Care AG

Accu-Chek FlexLink Plus
Model see letter
S/N: GWX 001 up to GWX 206 / GWY 001 up to GWY 034

MD: Infusion administration set, insulin

Deutsch 1

Deutsch 2

Français 1

Français 2

Vk_20110222_05
28.02.2011 CareFusion

PleurX drainage kits
Model 50-7500B, 50-7510
Lot: all

MD: Pleural drainage system

Deutsch

Français

English

Vk_20110222_09
28.02.2011 Microm International GmbH,Thermo Fisher Scientific

STP 420D, STP 420ES
S/N: 34273 - 48599
Software Version: V17

IVD: Tissue processor

Deutsch

English

Vk_20110222_18
21.02.2011 Roche Diagnostics GmbH

Accu-Chek Inform II blood glucose meter
Model 05060303001, 05060311011
S/N: < UU12500419
Software Version: < 3.01.01

IVD: Glucose rapid test system analyser

Deutsch

Français

English

Vk_20110215_16
21.02.2011 Ethicon LLC (As EAR)

Dermabond Topical skin adhesive
Model AHV12, AHVM12
Lot: CJP841, CKE811, CKE512

MD: skin adhesive

Deutsch

English

Vk_20110215_15
21.02.2011 EBI Electro-Biology, Inc.

Cross Connector Medium Titanium
Model 94672

MD: Spinal pedicle screw, fixation, appliance system

English

Vk_20110217_01
21.02.2011 Philips Medical Systems BV

CT Scanning system BRILLIANCE
Model 6, 10, 16, 16P, 40,64, ICT, ICT SP, Big Bore
S/N: see letter

MD: Full-body CT system

Deutsch

Français

English

Vk_20110215_11
21.02.2011 Philips Medical Systems BV

Fluoroscopic x-ray system BV Pulsera rel.2.3
Model 718095

 

Fluoroscopic x-ray system BVEndura rel.2
Model 718074

 

Fluoroscopic x-ray system BV Libra
Model 718022

 

Fluoroscopic x-ray system Field Extension for BV Libra
Model 718040

 

Fluoroscopic x-ray system Field Extension BV Endura
Model 718120

 

Fluoroscopic x-ray system Field extension BV Pulsera
Model 718121

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

Deutsch

Français

English

Vk_20110215_13
21.02.2011 Newdeal SAS

PANTA support device
Model 519110
Lot: all batches involved

MD: Orthopaedic bone nail driver

English

Vk_20110215_18
21.02.2011 Becton Dickinson GmbH

BD Tellurite Agar (Hoyle)
Model 256044
Lot: 1011313

IVD: Culture medium

Deutsch

Vk_20110216_02
21.02.2011 ICU Medical, Inc.

Orbit Infusion set, Orbit Micro infusion set
Model see letter
Lot: All lots starting with lot#1062302 thru and including lot#2045107

MD: Infusion pump administration set

Deutsch

Français

Italiano

English

Vk_20110216_06
21.02.2011 Varian Medical Systems Inc

VARIS Vision System
Model H83
Software Version: 7.3.10

MD: Radiation therapy treatment record/verify system

Deutsch

English

Vk_20110215_17
21.02.2011 Hartmann Paul AG

Hydrofilm, 10 cm x 12.5 cm, 10 ST
Model 685757/0
Lot: 000543118

MD: Semi-permeable film dressing

Deutsch

Vk_20110215_03
21.02.2011 ConMed Corp

VCARE Vaginal-Cervical Ahluwalia's Retractor-Elevator
Model 60-6085-100, 60-6085-101, 60-6085-102
Lot: 0901201 through 0907311 (inventory with an expiration date prior to August 2011)

MD: Uterine elevator

Deutsch

Français

Italiano

English

Vk_20110215_14
21.02.2011 Therakos, Inc.

Therakos UVAR XTS Photopheresis System Procedural Kits
Model XT125
Lot: Y703 to Y707, Y709 to Y726

MD: Photopheresis system

Deutsch

Français

English

Vk_20110215_12
14.02.2011 TORNIER S.A.

Aequalis Fracture Stem
Model DWA171, DWA172, DWA 173
S/N: see letter

MD: Coated shoulder humeral stem prosthesis

English

Vk_20110215_02
14.02.2011 Andreas Hettich GmbH & Co KG

Mikro 120

IVD: Clinical centrifuge

Deutsch1

Deutsch2

Français1

Français2

Vk_20110201_10
14.02.2011 Hamilton Medical AG

HAMILTON-G5 / S1
Model 159001 / 159005
Software Version: All HAMIL TON G5/S1 ventilators with software version V2.00x and neonatal option or V2.01x and neonatal option

MD: Ventilator

Deutsch

English

Vk_20110211_02
14.02.2011 GE Healthcare Japan Corporation; GE Hangwei Medical Systems Co., Ltd

BrightSpeed Excel Select, BrightSpeed Edge Select, BrightSpeed Elite Select
BrightSpeed Elite
Software Version: 09BW35.11;09HW30.4

MD: Full-body CT system

Deutsch

Vk_20110211_01
14.02.2011 DePuy Orthopaedics

DePuy Cement Restrictor
Model 546010000 / 546016000 / 546016000 / 546018000 / 546014000 / 546014000 / 546018000
Lot: see letter

MD: Polymer orthopaedic cement restrictor, non-absorbable, sterile

English

Vk_20110209_02
14.02.2011 AGA Medical Corporation

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

MD: Cardiac occluder

Deutsch

Français

Italiano

Vk_20110208_04
14.02.2011 NuMed Canada Inc

Coefficient
Model 303
Lot: JC-0563

 

Z-MED II
Model 305
Lot: JZ-7536

MD: Cardiac catheter, balloon, valvuloplasty

English

Vk_20110211_04
14.02.2011 Oasis Medical, Inc.

Corneal Marking Pads
Model 0441

MD: Unclassified

Deutsch

English

Vk_20110208_02
14.02.2011 Beckman Coulter Inc.

COULTER® HmX Hematology Analyzer with Autoloader
Model 6605522, 6605523, 6605524, 6605525, 6605526, 6605527, A85566, A85564

 

COULTER® MAXM Hematology Analyzer with Autoloader
Model 6604569, 6604687, 6705995, 6705996, 6705997, 6705998, 6705999, 6706000

 

COULTER® HmX Hematology Analyzer
Model 6605522, 6605523, 6605524, 6605525, 6605526, 6605527, A85566, A85564

 

COULTER® MAXM Hematology Analyzer
Model 6604569, 6604687, 6705995, 6705996, 6705997, 6705998, 6705999, 6706000

IVD: Haematology analyser, cell-differential; Haematology analyser, coagulation

Deutsch

Français

English

Vk_20110209_08
14.02.2011 Toshiba Medical Systems Corporation

Toshiba Ultrasonic Transducer
Model PST-65AT
S/N: 99A0632504

MD: Oesophageal ultrasound imaging system transducer, reusable

Deutsch

English

Vk_20110208_03
14.02.2011 TomoTherapy Inc.

TomoTherapy Treatment Systems

MD: Stereotactic-radiosurgical linear accelerator system

Deutsch

Français

Italiano

English

Vk_20110210_03
07.02.2011 Masimo

Pronto-7 rainbow 4D Reusable Sensor

MD: Pulse Co-oximeter probe, reusable

English

Vk_20110201_05
07.02.2011 Siemens AG

AXIOM SIRESKOP
Model SX,S3/ SD,S3; 3111676
S/N: 34157
Software Version: VB00D

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

Deutsch

English

Vk_20110201_01
07.02.2011 GE Medical Systems

ApexPro Telemetry system
Software Version: 3.9/4.0/4.1

MD: Electrocardiography telemetric monitoring system

Deutsch

Français

Vk_20110202_06
07.02.2011 St. Jude Medical Inc.

Cardio Life Research MitraXs

MD: Atrial retractor for cardiac surgery

English

Vk_20110201_03
07.02.2011 Beckman Coulter Inc.

Access HBsAg QC
Model A24294
Lot: 092326, 092327, 092328, 092329, 092330

IVD: Hepatitis B virus surface antigen IVD, control

Deutsch

Deutsch2

Français

Français2

English

Vk_20110202_13
07.02.2011 ResMed Savigny

VS Ill
Model VS3014700, VS3014701, VS3014706, VS3014707
S/N: see letter
Software Version: 1.00, 1.01, 1.02, 1.03, 1.04

MD: Ventilator

Deutsch

Français

English

Vk_20110201_04
07.02.2011 Varian Medical Systems Inc

Radiation Therapy treatment record/verify system
Model H51

MD: Radiation therapy treatment record/verify system

Deutsch

Français

Italiano

English

Vk_20110202_07
07.02.2011 aap Biomaterials GmbH & Co. KG

Ostim 35
Model 235101
S/N: 10JA34380

MD: Bone matrix implant, synthetic

Deutsch

Vk_20110204_03
07.02.2011 Mölnlycke Health Care AB

Mölnlycke Health Care Surgical Drape
Model 60502-00
Lot: 1051-4533 -0

MD: Surgical drape, general-purpose, single-use

Deutsch

Français

Italiano

English

Vk_20110201_13
07.02.2011 Smiths Medical ASD, Inc.

CADD-Solis Ambulatory Infusion Pump
Model 21-210x-xxxx-xx and 21-211x-xxxx-xx
S/N: see list
Lot: see list

MD: General-purpose infusion pump

Deutsch

Français

English

Vk_20110202_01
07.02.2011 Siemens Healthcare Diagnostics Inc.

ADVIA Chemistry Systems Ethanol_2 Reagent
Model 10379635

IVD: Alcohol kit

Deutsch

English

Vk_20110203_01
07.02.2011 Masimo

Rad 8 Pulse Oximeter
Software Version: V 4.8.1.8 or earlier

MD: Pulse oximeter, line-powered

English

Vk_20110201_06
31.01.2011 GE Medical Systems Israel, FI Haifa

Xeleris
Model 1.0, 1.1, 2.0, 2.1, 3.0

MD: Nuclear medicine system workstation

Deutsch

Français

English

Vk_20110131_01
31.01.2011 Siemens Healthcare Diagnostics Inc.

Dimension Creatinine Flex reagent cartridge
Model DF33A
Lot: FB1251, CA1260, BB1286

IVD: Creatinine kit

Deutsch

Français

English

Vk_20110126_08
31.01.2011 Radiometer Medical ApS

ABL90 FLEX sensor cassette
Model 946-008
Lot: R0031

IVD: Electrode, blood gas

English

Vk_20110125_08
31.01.2011 DePuy International Limited

LCS (manufactured by DEPuy, J&J)
Model 9075-15-004

MD: Knee prosthesis, internal, total

Deutsch

Vk_20110118_19
31.01.2011 Philips Neusoft Medical Systems Co., Ltd.

Philips Fluoroscopy System
Model Essenta RC
S/N: see letter

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

Deutsch

English

Vk_20110125_02
31.01.2011 Medical IntelligenceMedizintechnik GmbH

HeadFix System

MD: Head/neck positioning frame/board

Deutsch

Français

Italiano

English

Vk_20110127_07
31.01.2011 Triad Group, Inc; H&W cv

Alco-Prep Large
Model 610H

 

Alco-Prep Medium
Model 10-3001H

 

Alco-Swab
Model 10-4300H

 

Lot: All lot nr since 2007

MD: Wet wipe; Swab/Swabsticks

Deutsch

Français

English

Vk_20110128_01
31.01.2011 Becton Dickinson Biosciences

BD FACS 7-Color Setup Beads
Model 335775
Lot: 83284, 87471

IVD: Flow Cytometry Controls, Setup Beads

English

Vk_20110126_06
31.01.2011 Coloplast A/S

Peristeen Anal Irrigation System

MD: Anal Irrigation System

Deutsch

Français

Italiano

Vk_20110111_02
31.01.2011 Radiometer Medical ApS

ABL90 FLEX
Model 393-090
Software Version: 2.4.1680.25

IVD: Blood gas/pH/electrolyte/metabolite analyser

Deutsch

English

Vk_20110125_07
24.01.2011 Medtronic Inc.

SynchroMed II and SynchroMed EL Implantable Drug Pumps and Refill Kits
Model Pump Models: 8637-20, 8637-40, 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18
Refill Kit Models: 8551, 8555, 8561, 8562, 8564, 8565, 8566
S/N: all

AIMD: General-purpose implantable infusion pump, programmable

Deutsch

Français

Italiano

Vk_20110118_13
24.01.2011 Mölnlycke Health Care AB

Procedure Pack
Model 97009965-0397009970-0297012985-0197013510-0297024517-0097024517-01
S/N: Voir FSCA

MD: Non-medicated general surgical procedure kit, single-use

Deutsch

Français

Italiano

Vk_20110120_01
24.01.2011 GE Medical Systems LLC

Discovery MR 750 3.0 T and MR MR450 1.5T and Optima MR450w 1.5T systems

MD: Magnetic resonance imaging system

Deutsch

Italiano

Vk_20110118_21
24.01.2011 ArcRoyal; UnoMedical Ltd

Unomedical Sterile Urine Drainage Bag

MD: Urine collection bag

English

Vk_20110119_05
24.01.2011 Unomedical Devices

Non-rebreathing oxygen mask

 

Aerosol face mask

 

Rebreathing oxygen mask

 

Nebuzeling system, non heated

 

Venturi oxygen face mask

MD: Non-rebreathing oxygen face mask

Aerosol face mask rebreathing

Rebreathing oxygen face maskt

Nebulizing system, non-heated

Venturi oxygen face mask

Deutsch1

Deutsch2

Français1

Français2

Italiano1

Italiano2

English1

English2

Vk_20110121_03
24.01.2011 Codman and Shurtleff, Inc.

Codman Disposable Drill Kit
Model 80-1185, 80-1190, 80-1196, 82-6607
Lot: see letter

MD: Cranial hand drill, single-use

Deutsch

Vk_20110119_04
17.01.2011 Molift AS

Molift Smart medical hoist
Lot: 0920001

MD: medical hoist

Français

Vk_20110106_04
17.01.2011 Cardiac Pacemaker Inc

Latitude patient management server software
Model 6465
Software Version: V6.1.07

MD: Patient health record information system application software

Deutsch

Français

English

Vk_20110112_01
17.01.2011 GE Healthcare

GE Centricity PACS IW
Software Version: 1.0.0.x

MD: Picture archiving and communication system, radiology

Deutsch

Vk_20110113_01
17.01.2011 Abbott GmbH & Co. KG

Architect Anti-HCV Reagent Kit
Model 6C37-20, 6C37-25, 6C37-30
Lot: all

IVD: Hepatitis C virus total antibody kit

Deutsch

Français

Italiano

English

Vk_20110112_02
17.01.2011 ConMed Corporation

System 2450
Model 60-2450-230
S/N: All
Lot: All

MD: Electrosurgical diathermy system generator

Deutsch

Français

Italiano

English

Vk_20110114_01
17.01.2011 Siemens AG

MAGNETOM Avanto
Model 7391167
S/N: 27294

MD: MRI system, full-body, permanent magnet

Deutsch

English

Vk_20110114_02
17.01.2011 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; IAK-05845
Lot: All lot numbers from above referenced Model numbers

MD: Cardiac catheter, balloon, intra-aortic

Deutsch

Français

Italiano

Vk_20110111_01
17.01.2011 Angiomed GmbH & Co.

BARD LifeStent Vascular Stent System
Model EX062001L, EX072001L, EX062003L, EX072003L
Lot: all

MD: Stent, vascular

Deutsch

English

Vk_20110111_10
17.01.2011 Edwards Lifesciences LLC

Ascendra 2 Delivery System
Model 9320AS23 und 9320AS26
Lot: All

MD: Cardiac catheter, balloon, valvuloplasty

Deutsch

Français

English

Vk_20110114_03
17.01.2011 Elekta Limited

Digital Imager, radiation therapy
Model XVI

MD: Digital imager, radiation therapy

English

Vk_20110113_03
17.01.2011 Philips Medical Systems

Precedence Imagining
Model 16 Slice 3/8'', 16 Slice 5/8'', 6 Slice 3/8'', and 6 Slice 5/8''
S/N: see FSN

 

Skylight
Model 8FT-3/8'' SPECT, 9FT-3/8'' SPECT, 8FT-5/8'' SPECT, 9FT-5/8'' SPECT, AZ 8FT 3/8'', AZ 8FT 5/8'' AZ 9FT 3/8'' and AZ 9FT 5/8''
S/N: see FSN

MD: SPECT/CT system; Stationary gamma camera system

English

Vk_20110117_01
10.01.2011 Gambro Lundia AB

AK 200 Ultra and AK 200 Ultra S
Model 107108 (AK 200 ULTRA S) and IO 1139 (AK 200 ULTRA)
S/N: All
Software Version: AK 200 ULTRA S <=9.20 and AK 200 ULTRA <=8 .00

MD: Haemodialysis system

English

Vk_20101221_02
10.01.2011 Medtronic MiniMed

Update

Paradigm Veo
Model MMT-554 and MMT-774

MD: Ambulatory insulin infusion pump

Deutsch

Français

Vk_20101221_03
10.01.2011 Horiba ABX

ABX MICROS 60

IVD: Haematology analyser, cell-differential

Deutsch

Français

English

Vk_20110105_02
10.01.2011 Diagnostica Stago

STA Neoplastin R 15ml
Model 03263347 140
Lot: 624171

IVD: Prothrombin time kit

Deutsch

Vk_20101229_04
10.01.2011 Siemens Healthcare Diagnostics Inc.

Stratus CS STAT Acute Care Troponin I TestPak
Model CCTNI
Lot: 230200002 or greater

IVD: Troponin kit

Deutsch

Deutsch2

Francais

Français2

English

English2

Vk_20110104_10
10.01.2011 Roche Molecular Systems Inc.

COBAS AmpliPrep/COBAS TaqMan HBV Test, version 2.0

IVD: Hepatitis B Virus - NA Reagents

Deutsch

Français

Vk_20101228_17
10.01.2011 Philips Medical Systems

IntelliVue Information Center
Model see letter

MD: Patient monitoring system central station monitor

Français

English

Vk_20110107_01
10.01.2011 Cardiac Pacemaker Inc

Acuity Universal Cutter
Model 7060
S/N: Z0000038, Z0000039, Z0000054

AIMD: Catheter slitter

Deutsch

English

Vk_20110106_06
10.01.2011 MEDTEC Inc.

Body Pro-Lok SBRT System
Model MTSBRT002
S/N: see letter

MD: Indexed-immobilization patient positioning system

Deutsch

Français

Italiano

English

Vk_20110107_02
10.01.2011 Biomet France SARL

TESS Glenoid - Anatomic Insert PE
Model P1700120 (T0); P1700178 (T1); P1700180 (T2); P1700182 (T3)
Lot: All

MD: Total shoulder prosthesis

English

Vk_20101223_01
10.01.2011 Varian Medical Systems UK Ltd

Clinac C Series
Model H14, H27, H29 and HCX

MD: Linear accelerator system

Deutsch

Français

Italiano

English

Vk_20110104_12
10.01.2011 Siemens Healthcare Diagnostics Inc

ADVIA Centaur HIV Ag/Ab Combo (CHIV) Assay Quality Control Kit
Model 06520544
Lot: 479970461, 480380461, 501120651, 503330651, 515640651, 526530651, 553090651, 613381691, 621391691, 634431691, 547351691, 551271691, 590161691, 599021691, 610281691

IVD: Human immunodeficiency virus multiple antibody kit

Deutsch

English

Vk_20110105_01
10.01.2011 Johnson & Johnson International

Ethilon, Ethibond, Mersilene
Model See list
Lot: See list

MD: Suture, polyamide

Deutsch

Français

English

Vk_20110106_05
10.01.2011 Siemens Healthcare Diagnostics Inc.

ADVIA Chemistry Systems Ethanol_2 Reagent
Model 10379635

IVD: Alcohol kit

Deutsch

English

Vk_20110105_04
03.01.2011 Beckman Coulter Inc.

Access Free T4 Calibrator
Model PN 33885
Lot: 014769

IVD: Free thyroxine kit

Deutsch

Vk_20101228_15
03.01.2011 Siemens Healthcare Diagnostics Inc

ADVIA Centaur CA 125 II
Model 128533, 128532
Lot: 62431144, 63124144, 63519144, 63876144, 62450144, 63822144

IVD: Cancer antigen 125 kit

Deutsch

Vk_20101228_16
03.01.2011 Air Liquide DMC

Portable Freelox2

MD: portable oxygen tank

Deutsch

Deutsch2

Français

Français2

Vk_20110103_02
03.01.2011 GE Medical Systems Israel, FI Haifa

Xeleris

 

eNTEGRA

MD: Nuclear medicine system workstation

Deutsch

Français

English

Vk_20101229_14
03.01.2011 Fresenius Vial

Injectomat Agilia TIVA
Model Z018246, Z018220, Z018257, Z018280, Z018210, Z018251, Z018230,Z018262, Z018245, Z018260, Z018290, Z018255, Z018270, Z018256, Z018250
S/N: 20133013 to 20942416
Software Version: rev 4.0d or 4.1b

MD: Syringe pump

English

Vk_20101228_09
03.01.2011 Hospira Inc

Hospira Gemstar Pump Sets
Model see letter
S/N: see letter

 

Hospira GemStar Pump Set with Convertible Pin
Model see letter
S/N: see letter

 

Hospira Gemstar Pump Set SL
Model see letter
S/N: see letter

MD: Infusion pump administration set

Deutsch

Français

Italiano

English

Vk_20101228_08