Materiovigilance – Liste Rückrufe

Medizinprodukte – Rückrufe und andere Sicherheitsmassnahmen (FSCA)
Datum Hersteller Handelsname Produktbeschreibung Informationen Referenz Nr. 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