Matériovigilance – liste des retraits

Dispositifs médicaux – Liste des retraits de produits et autres mesures correctives (FSCA)
Date Fabricant Nom commercial Description du produit Informations Nº de référence Swissmedic
20.02.2017 Siemens Healthcare Diagnostics Products Limited

Sex Hormone Binding Globulin (SHBG) IVD
Model L2KSH2
Lot: 357,358, 360, 361, 363

IVD: Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay

de

fr

Vk_20170213_08
20.02.2017 Nihon Kohden Corp.

Celltac G
Model MEK-9100
S/N: see FSN

IVD: Haematology analyser, cell differential

de

en

Vk_20170210_02
20.02.2017 Abbott, Inc.

HeartMate PHP Percutaneous Heart Pump Catheter
Model 10002111 / 109875
Lot: all

MD: Intracardiac circulatory assist axial-pump catheter

de

fr

it

en

Vk_20170207_06
20.02.2017 Smith & Nephew Inc.

Secura Protective Cream Z10
Model 59447525
Lot: 626110

MD: Skin moisture barrier dressing

en

Vk_20170207_04
20.02.2017 IRIS International

iChemVELOCITY
Model see letter
S/N: all

IVD: Laboratory urine analyser IVD, automated

de

fr

en

Vk_20170208_20
20.02.2017 CareFusion Switzerland 317 Sàrl

Alaris Plus Syringe Pump
Model 8005TIG01
S/N: 500000126
Software Version: V4.1.8

MD: Syringe pump

en

Vk_20170209_04
20.02.2017 Codman & Shurtleff, Inc

Detachment Control Box
Model DCB000001-20, DCB00000500
Lot: All

 

Microcoil Delivery System
Model See FSN
Lot: All

MD: Neurovascular embolization coil

en

Vk_20170208_10
20.02.2017 DiaMed GmbH

ID-DiaCell ABO/I-II(-III), ID-DiaCell ABO devices
Model See FSN
Lot: all

 

ID-DiaScreen, ID-DiaCell, ID-DiaPanel, ID-Dia devices
Model See FSN
Lot: all

IVD: Immunohaematology (Blood Grouping)

en - 1

en - 2

Vk_20170213_02
20.02.2017 B. Braun Surgical, S.A.

BONE WAX STICK
Model 1029755
Lot: From 212055 to 216363

MD: Bone wax, natural

de

Vk_20170214_01
20.02.2017 Boston Scientific Corporation

AngioJet Ultra System Console
Model see FSN
Lot: see FSN

MD: General-purpose suction system, line-powered

de

fr

it

en

Vk_20170208_11
20.02.2017 Weinmann Emergency Medical Technology GmbH + Co.KG

Batteriepack MEDUCORE Easy
Model 40155

MD: Defibrillator, automatic, external

de

en

Vk_20170216_04
20.02.2017 Zimmer, Inc.

Comprehensive Reverse Shoulder Tray
Model 115340
Lot: see FSN

MD: Reverse shoulder prosthesis body

en

Vk_20170111_07
20.02.2017 Endologix International Holdings B.V.

Update

AFX EndoVascular AAA System
Model all

MD: Abdominal aorta endovascular stent-graft

de

fr

it

en

en - Update

Vk_20161220_10
20.02.2017 LeMaitre Vascular, Inc.

Update

Hydro LeMaitre Valvulotome
Model 1009-00, 1009-00J
Lot: Update: additional lots affected (see FSN)

MD: Valvulotome

de - 1

de - 2

de - Update

fr - 1

fr - 2

fr - Update

it - 1

en - 1

en - 2

en - Update

Vk_20160809_08
14.02.2017 GE Medical Systems

Discovery MR450 1.5T narrow bore 1.5T non-GEM

MD: Full-body MRI system, superconducting magnet

de

fr

it

en

Vk_20170202_04
14.02.2017 BioMérieux SA

VITEK MS instrument
Model 410895
Software Version: KB V2.0 clinic and V3.0 clinic

IVD: Microbial identification mass spectrometry system IVD

de

fr

en

Vk_20170206_01
14.02.2017 Roche Diagnostics GmbH

cobas HIV-1 Test for use on the cobas 4800 system
Model 06979599190
Lot: all

 

cobas HBV Test for use on the cobas 4800 system
Model 06979564190
Lot: all

IVD: HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT); Hepatitis B virus core nucleic acid IVD, kit, nucleic acid technique (NAT)

de

fr

en

Vk_20170203_08
14.02.2017 Genesee BioMedical Inc

KORING
Model KR-25, KR-30, KR-35
Lot: KR-25: KR14258, KR13191; KR-30: KR14473; KR-35: KR14258, KR13192

MD: Stoma support implant

de

fr

en

Vk_20170203_13
14.02.2017 HASE

TRIX

 

Kettwiesel

 

Trets Reh

MD: Unclassified

de

fr

it

Vk_20170117_01
14.02.2017 MAQUET Cardiopulmonary GmbH

HCU40
S/N: all below 90441000

MD: Cardiopulmonary bypass system heat exchanger

de

fr

it

en

Vk_20170118_04
14.02.2017 Brainlab AG

Brainlab Offset Cup Impactor Universal
Model 52856, 52856A

MD: Robotic surgical navigation system

de

fr

it

en

Vk_20170201_03
14.02.2017 Atrium Medical Corporation

ATRIUM THORACIC CATHETERS
Model 8008 (8Fr thoracic catheter) and 8010 (10Fr thoracic catheter)
Lot: All

MD: Pleural catheter

de

fr

en

Vk_20170201_05
14.02.2017 HOYA Corporation

PENTAX ULTRASOUND VIDEOBRONCHOSCOPE
Model EB-1970UK

MD: Flexible ultrasound bronchoscope

de

fr

it

en

Vk_20170201_02
14.02.2017 Carl Zeiss Meditec AG

VisuMax
Model 1345-518
Software Version: 2.10

MD: Femtosecond ophthalmic diode-pumped solid-state laser system

de

en

Vk_20170201_10
14.02.2017 Samsung Electronics Co., Ltd

Diagnostic X-ray System
Model GU60A

MD: Stationary basic diagnostic x-ray system, digital

de

fr

it

en

Vk_20170126_02
14.02.2017 Zimmer GmbH

Modular femoral heads, Protasul S30 femoral heads, Metasul heads that can be used in a metal on polyethylene combination with different devices systems - see FSN

MD: Metallic femoral head prosthesis

de

fr

it

en

Vk_20160826_12
14.02.2017 Ortho Clinical Diagnostics Inc.

VITROS Chemistry Products Na+ Slides
Model 8379034

IVD: Sodium (Na+) IVD, reagent

de

fr

en

Vk_20170103_02
14.02.2017 bioMérieux

Update

various ETEST Systems
Model see FSN
Lot: see FSN

IVD: antimicrobial minimum inhibitory concentration (MIC) IVD

de

de - Update

fr

fr - Update

en

en - Update

Vk_20161227_06
06.02.2017 Occlutech GmbH

Occlutech Occlusions-Pusher, Flex-Pusher II
Model 50FP100, 51FP060, 51FP100, 51FP120, 51FP160, 50OP020

MD: Wire driver

de

fr

it

en

Vk_20170125_04
06.02.2017 Siemens Healthcare Diagnostics Inc.

Advia Centaur Systems Calibrator A
Model see FSN
Lot: see FSN

IVD: Multiple human hormone IVD, calibrator

de

fr

en

Vk_20170130_02
06.02.2017 Siemens Healthcare Diagnostics Products GmbH

INNOVANCE D-Dimer
Model OPBP03, OPBP07

IVD: D-dimer kit

de

fr

en

Vk_20170130_05
06.02.2017 Diagnostica Stago

STA-Cuvettes
Model 38669
Lot: see FSN

IVD: INSTRUMENTS , CONSUMABLES, SPARE PARTS, SOFTWARE, SERVICE

de

fr

en

Vk_20170125_11
06.02.2017 Becton Dickinson and Company Limited

BD Plastipak Syringe, CT with Luer Slip Adaptor
Model 300605

MD: General-purpose syringe, single-use

de

fr

en

Vk_20170124_07
06.02.2017 Olympus Winter & Ibe GmbH

Video Telescope ENDOEYE HD II (0 Grad, 30 Grad)
Model WA50040A (0 Grad), WA50042A (30 Grad)

MD: Flexible video laparoscope

de

fr

it

Vk_20170127_03
06.02.2017 Medtronic Inc.

Medtronic Strata II
Model see FSN

 

Strata NSC Valves
Model see FSN

MD: Hydrocephalic shunt; Ventriculo-peritoneal/atrial shunt valve

en

Vk_20170131_02
06.02.2017 Roche Diagnostics GmbH

Anti-HAV
Model 04854977190

IVD: Hepatitis A Virus

de

fr

it

en

Vk_20170130_08
06.02.2017 Oertli Instrumente AG

OS4
Model VC860300
Software Version: V1.3.0 and earlier software versions

MD: Phacoemulsification system generator

de

fr

en

Vk_20170130_07
31.01.2017 Dornier MedTech GmbH

Dornier Gemini
S/N: 1 - 50

MD: Lithotripters, Extracorporeal

de

en

Vk_20170110_05
31.01.2017 Siemens Healthcare Diagnostics Inc.

ADVIA Centaur Systems Progesterone
Model 10310305, 10315522, 10333111
Lot: all

 

Dimension Vista LOCI Progesterone
Model 10461743
Lot: all

 

Immulite Progesterone
Model 10381128, 10381181, 10381170
Lot: all

IVD: Progesterone IVD, kit, chemiluminescent immunoassay; Progesterone kit

de

fr

en

Vk_20170118_03
31.01.2017 Immucor GTI Diagnostics, Inc.

Pak LxTM Assay
Lot: 3003658, 3004022

IVD: Antibody detection (Immunohaematology)

de

en

Vk_20170123_06
31.01.2017 Medline International France SAS

Sterile Procedure Trays containing Devon Light Gloves
Model see FSN
Lot: see FSN

MD: Operating/examination/treatment light handle cover, single-use

de

fr

it

Vk_20170123_03
31.01.2017 Carestream Health Inc

DRX-Revolution Mobile X-Ray System
S/N: 101 to 2545

MD: Mobile basic diagnostic x-ray system, digital

de

fr

it

en

Vk_20170119_08
31.01.2017 Zimmer Biomet

Vanguard Open Box Femoral Component
Model 183100, 183102, 183104, 183106, 183108, 183110, 183112, 183113, 183120, 183122, 183124, 183126, 183128, 183130, 183132, 183133
Lot: See FSN

MD: Uncoated knee femur prosthesis

en

Vk_20170123_08
31.01.2017 bioMérieux SA

ETEST XM256 (Cefuroxime)
Model 506958, 506918, 412304, 412305
Lot: see FSN

IVD: Cefuroxime minimum inhibitory concentration (MIC) IVD

de

fr

en

Vk_20170119_09
31.01.2017 RaySearch Laboratories AB

RayStation
Model 4.5, 4.7, 5.0, 6.0
Software Version: 4.5, 4.7, 5.0, 6.0

MD: Radiation therapy treatment planning system

de

fr

it

en

Vk_20170120_12
31.01.2017 ArcRoyal Ltd

Procedure trays ArcRoyal
Model See FSN
Lot: See FSN

MD: General surgical procedure kit, non-medicated, single-use

de

fr

en

Vk_20170116_03
31.01.2017 Bard Medical Division

Multi-length ureteral stents
Model see FSN
Lot: all unexpired products

MD: Polymeric ureteral stent

de

fr

en

Vk_20170120_01
23.01.2017 Advanced Sterilization Products

STERRAD NX Steriliser
Model 10033; 10033-002

MD: Plasma sterilizer

de

fr

it

en

Vk_20170110_04
23.01.2017 Vigmed AB

SWiTCH, Needle protected safety catheter
Model SW204501, SW223501, SW224501
Lot: P8096, P8097, P8098, P8251

MD: Arterial blood pressure catheter

de

fr

it

Vk_20170113_03
23.01.2017 Cousin Biotech s.a.s.

LIFT / SOFT LIFT
Model GCBINLIFTU; GCBINSOFTU; GCBINSLXLU
Lot: strictly less than 163172

 

BIOMESH SOFT PROLAPS
Model GCBCYSTOSU; GCBRECTOSU
Lot: strictly less than 163172

MD: Female stress urinary incontinence surgical mesh; Pelvic organ prolapse surgical mesh, composite-polymer

de

fr

it

en

Vk_20170116_05
23.01.2017 bioMérieux SA

NucliSENS easyMAG Magnetic Silica
Model 280133
Lot: see FSN

IVD: Nucleic acid extraction/isolation kit IVD

de

fr

en

Vk_20170111_14
23.01.2017 IRIS International

iChemVELOCITY Chemistry Strips
Model 800-7204
Lot: 720410.1A

IVD: Kit, screening, urine

de

fr

en

Vk_20170111_11
23.01.2017 Biomerieux

VIDAS 3 System
Model 412590
S/N: all

 

VIDAS LYME IgG
Model 30320
Lot: 1004827120, 1005029860, 1005160750, 1005277530 and 1005330240

IVD: Laboratory fluorescent immunoassay analyser IVD, automated

de

fr

en

Vk_20170113_06
23.01.2017 Kisco International

CAGE HOLDER
Model HD0060
Lot: 15486

MD: Orthopaedic implant/trial-implant holder

de

fr

en

Vk_20170113_04
23.01.2017 bioMérieux SA

BK Virus R-gene Real-time Detection and Quantification Kit
Model 69-013B

IVD: BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

de

fr

en

Vk_20170116_06
23.01.2017 Becton Dickinson & Company (BD)

BD Eclipse Injection Needle
Model 305757, 305781-305786, 305793, 305795

 

BD Preset Eclipse Arterial Blood Collection Syringe
Model 364389, 364390, 364391, 364393

MD: Blood gas syringe/needle, lithium heparin

de

fr

it

en

Vk_20170112_10
23.01.2017 Siemens Healthcare Diagnostics Inc

Ammonia Flex reagent cartridge
Model Dimension & VISTA; SMN 10711992, P/N K3119, SMN 10711991, P/N DF119
Lot: see FSN

IVD: Ammonia IVD, kit, enzyme spectrophotometry

de

fr

en

Vk_20170112_08
23.01.2017 Siemens Healthcare GmbH

Mammomat Inspiration-System
Model 10140000
Software Version: VB30

MD: Stationary mammographic x-ray system, digital

de

en

Vk_20170112_11
23.01.2017 Siemens Healthcare Diagnostics Products GmbH

N Latex HCY
Model OPAX032, OPAX055
Lot: 802907632; 802907632 BCS

IVD: Homocysteine

fr

en

Vk_20170112_01
23.01.2017 Roche Diagnostics GmbH

Update

Gentamicin
Model see letter
Lot: see letter

IVD: Gentamicin kit

de - 1

de - 2

de - 3

fr - 1

fr - 2

fr - 3

en - 1

en - 2

en - 3

Vk_20160525_05