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
05.12.2016 Siemens Healthcare Diagnostics Products Limited

IMMULITE 1000 PSA
Model LKPS1, LKPS5; SMN 10380960, 10380949
Lot: all

 

IMMULITE 2000 Xpi PSA
Model L2KPS2, L2KPS6; SMN 10380986, 10380996
Lot: all

 

IMMULITE PSA
Model LKPS1, LKPS5; SMN 10380960, 10380949
Lot: all

 

IMMULITE 2000 PSA
Model L2KPS2, L2KPS6; SMN 10380986, 10380996
Lot: all

IVD: Prostate specific antigen kit; Total prostate specific antigen (PSA) IVD, kit, chemiluminescent immunoassay

de

fr

en

Vk_20161128_12
05.12.2016 Ortho Clinical Diagnostics

ORTHO VISION Analyzer for ORTHO BioVue Cassettes
Model 6904579
Software Version: 3.6.0 and below

 

ORTHO VISION Max Analyzer for ORTHO BioVue Cassettes
Model 6904578
Software Version: 3.6.0 and below

IVD: Blood group/antibody screening analyser IVD, automated

en

Vk_20161124_06
05.12.2016 APELEM

Platinum dRF
S/N: All Platinum tables equipped with SIPRO motorization and with M32 software release v6R33 and v6R34
Software Version: Sofware M32 with release v6R33 or v6R34

MD: Bedside imaging x-ray system table, non-powered

fr

en

Vk_20161124_05
05.12.2016 BioMérieux SA

NucliSENS easyMAG Magnetic Silica
Model 280133
Lot: See FSN

 

miniMAG
Model 200293
Lot: See FSN

IVD: Nucleic acid extraction/isolation kit IVD

de

fr

en

Vk_20161128_13
05.12.2016 Fujifilm Corporation

FUJIFILM Flexible Duodenoscope
Model ED-530XT & ED-530XT8
S/N: all

MD: Flexible video duodenoscope

de

fr

it

en

Vk_20161125_08
05.12.2016 Institut Straumann AG

Starter Set surg. instr. / Drill / Twist Drill
Model 040.330 / 044.210, 044.214, 044.215 / 044.255
Lot: MM191/ MG950, LV463, MG783, MH027, ML700, MJ330, MK547, LV457 / LV455

MD: Fluted surgical drill, reusable

de

fr

en

Vk_20161123_03
05.12.2016 Wright Medical Technology Inc.

SWANSON GROSSZEHE, TITAN SZ 4
Model 4833104
Lot: 1558414

MD: Total metatarsophalangeal joint prosthesis, multiple-piece

de

fr

it

en

Vk_20161128_01
05.12.2016 Datex-Ohmeda, Inc (GE Healthcare)

Avance
Model 1009-9002-000

 

Avance CS2
Model 1009-9050-000

 

Amingo
Model 1009-9013-000

MD: Neonatal/adult intensive-care ventilator; Anaesthesia workstation, general-purpose

de

fr

it

en

Vk_20161123_11
05.12.2016 Newdeal SAS

Forefoot 1.5 set
Model 109900
Lot: all

MD: Container, sterilization

de

fr

en

Vk_20161125_03
05.12.2016 Ascensia Diabetes Care Holdings AG

CONTOUR DIABETES App
Software Version: 1.2 or lower

MD: Data management system, patient

en

Vk_20161123_09
05.12.2016 Haag-Streit AG

EyeSuite DICOM Option / DICOM Lizenz
Model EyeSuite i8.2.1.0 / 7220374 / 7220379

MD: Medical image management system

de

fr

en

Vk_20161123_07
05.12.2016 Siemens Healthcare GmbH; Business Area Advanced Therapies

AXIOM Artis systems
S/N: AXIOM Artis systemswith SW version VB35E and Megalix X-raytubes
Software Version: with SW version VB35E

MD: Stationary angiographic x-ray system, digital

de

fr

it

Vk_20161128_05
05.12.2016 Domain Surgical Inc.

FMsealer Open Shears
Model FM3001
Lot: 153411, 160321, 160531, 160991, 161311, 161442, 161871, 162091

MD: Unclassified

en

Vk_20161121_02
05.12.2016 Siemens Healthcare GmbH

Artis Zee
Model Artis zee with SW versions VC21C, VD11 and Megalix Cat+ X-ray tubes
Software Version: VC21C, VD11

MD: Stationary angiographic x-ray system, digital

de

fr

en

Vk_20161123_06
05.12.2016 Ortho Clinical Diagnostics

Update

VITROS Intact PTH Reagent and Calibrator
Model 6802892, 6802893
Lot: 0700 (Expiry 18-Oct-16), 0710 (Expiry 14-Nov-16), 0728 (Expiry 12-Dec-16), 0738 (Expiry 02-Jan-17), 0748 (Expiry 06-Feb-17), 0758 (Expiry 06-Mar-17), 0768 (Expiry 10-Apr-17), and: see FSNs

IVD: Intact parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

de

en

en - Update

Vk_20161010_03
05.12.2016 Codan Argus AG

Update

CODAN ARGUS 718 V
Software Version: all

 

CODAN ARGUS 717 V
Software Version: all

MD: General-purpose infusion pump, line-powered

de

de - Update

fr

it

en

en - Update

Vk_20160823_10
28.11.2016 Ulthera Inc.

Cellfina System
Model 5036324
Lot: 100092709, 100092710

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

de

fr

it

en

Vk_20161121_06
28.11.2016 Smiths Medical ASD Inc

Jelco® PROTECTIV® ACUVANCE® 2 I.V. Safety Catheter
Model 1720-AI
Lot: 3120882, 3120883, 3220733

MD: Peripheral vascular infusion catheter

de

fr

it

Vk_20161122_01
28.11.2016 Siemens Medical Solution Diagnostic Ltd

IMMULITE 2000 PSA
Model L2KPS2
Lot: 408

 

IMMULITE 2000 Xpi PSA
Model L2KPS6
Lot: 408

IVD: Total prostate specific antigen (PSA) IVD, kit, chemiluminescent immunoassay

de

Vk_20161115_05
28.11.2016 Abbott

ARCHITECT Toxo IgM
Model 6C20-25, 6C20-35
Lot: 64245LI00, 66063LI00, 67003LI00, 68443LI00, 69252LI00, 70171LI00, 64248LI00, 66066LI00, 67006LI00, 68444LI00, 69253LI00, 70174LI00

IVD: Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

de

fr

it

en

Vk_20161115_04
28.11.2016 Roche Diagnostics GmbH

cobas b123 POC System
Model cobas b 123 <3> POC system (model number: 05122279001)cobas b 123 <4> POC system (model number: 05122287001)
Lot: all
Software Version: SYSTEM SOFTWARE 4.7 cobas b 123 POC system (model number: 05064694001)

IVD: Blood gas/pH/electrolyte/metabolite analyser

de

fr

it

en

Vk_20161117_08
28.11.2016 medi1one medical gmbh

I800 PEG/SPK-Verband-Set
Model 77707115 / 77707116 / 7752272
Lot: See Fsn

MD: Procedure Kit/Trays, Dressing

de

Vk_20161114_06
28.11.2016 Greatbatch Medical

Offset Reamer Handle
Model: T5766, catalogue: 00-7804-080-00
Lot: see fsn

MD: Orthopaedic reamer handle

de

fr

it

en

Vk_20161117_03
28.11.2016 Smith & Nephew, Inc.

Modular Neck Hip Prostheses of the Modular SMF and Modular REDAPT Revision Femoral Hip Systems
Model see FSN
Lot: see FSN

MD: Coated femoral stem prosthesis, modular

de

fr

it

en

Vk_20161116_09
28.11.2016 Radiometer Medical ApS

AQURE system
Model 933-599 (AQURE)
Software Version: 2.2.0

IVD: Clinical data collection/management information system application software

fr

en

Vk_20161118_05
28.11.2016 Siemens AG, Healthcare Sector, Buisness Unit AX

Artis Q
Software Version: VD11

MD: Stationary angiographic x-ray system, digital

de

fr

en

Vk_20161107_04
21.11.2016 Spectranetics Corporation

Bridge Occlusion Balloon
Model 590-001
Lot: FMN16F22A, FMN16H23A

 

ELCA Coronary Laser Atherectomy Catheter
Model 114-009, 117-205
Lot: FTT16D07A, FBB16F01A

 

Turbo Elite Laser Atherectomy Catheter
Model 414-151, 417-152, 420-006
Lot: FAY16D26A, FAZ16E06A, FBA16D04A, FBA16E13A, FBA16F21A, FBA16H17A, FBA16J07A, FBA16E13A

MD: Intravascular occluding catheter; Atherectomy laser system beam guide-catheter, coronary and peripheral

de - 1

de - 2

fr - 1

fr - 2

en - 1

en - 2

Vk_20161111_07
21.11.2016 Philips Healthcare

Brilliance 10

 

Brilliance 16P

 

Brilliance 6, Brilliance 16, Brilliance 40, Brilliance 64, Brilliance Big Bore, Brilliance iCT, Brilliance iCT SP

 

Ingenuity CT, Ingenuity Core, Ingenuity Core128

MD: Full-body CT system

de

fr

it

en

Vk_20161109_06
21.11.2016 Biomet Orthopaedics Switzerland GmbH

OPTIPAC BONE CEMENT
Model see FSN
Lot: see FSN

MD: Orthopedic Cement

de

fr

it

en

Vk_20161115_03
21.11.2016 IMPAC Medical Systems Inc.

Monaco RTP System
Software Version: Version 5.10 and higher

MD: Radiation therapy application software

de

fr

it

en

Vk_20161114_09
21.11.2016 Mathys AG Bettlach

balanSys UNI convex PE inlays x/5
Model 77.30.0211; 77.30.0221; 77.30.0231; 77.30.0241; 77.30.0251
Lot: all

MD: Knee prosthesis, internal, tibial component

de

fr

it

en

Vk_20161108_11
21.11.2016 Concert Medical LLC

Galeo Pro Coronary Guide Wire
Model 389781, 389782, 389783, 389784, 389785, 389786, 389787, 389788, 389791
Lot: See FSN

MD: Cardiac guidewire, single-use

de

fr

it

en

Vk_20161109_01
21.11.2016 Bayer Medical Care Inc.

MEDRAD Intego PET Source Administration Sets
Model INT CSS

MD: Electric infusion pump administration set, single-use

de

fr

en

Vk_20161109_08
21.11.2016 Siemens AG, Healthcare Sector, Buisness Unit AX

SOMATOM Definition AS
Model manufactured from May 2008 until December 2013

 

SOMATOM Definition Flash
Model manufactured from September 2009 until July 2012

MD: CT system application software

de

fr

it

en

Vk_20161111_12
21.11.2016 AbbVie Inc.

AbbVie PEG 20FR Tube
Model 062945-001
Lot: 32085235

MD: Gastrostomy tube

de

en

Vk_20161110_01
21.11.2016 Synthes GmbH

SynReam Flexible Shaft
Model 352.044; 352.040
Lot: see FSN

MD: Medullary canal orthopaedic reamer, flexible

de

en

Vk_20161111_13
21.11.2016 ACUTRONIC Medical Systems AG

Fabian HFO
Model 7200, 7200.i, 7201

 

fabian evolution
Model 7250, 7250.N

MD: Neonatal intensive-care ventilator

en

Vk_20161115_02
21.11.2016 Exactech Inc.

Equinoxe Reverse Shoulder Defining Screw Kit
Model 320-20-00

MD: Total shoulder prosthesis

de

fr

it

Vk_20161104_10
21.11.2016 ArcRoyal Ltd

Procedure trays ArcRoyal
Model see FSN
Lot: see FSN

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

de

fr

Vk_20161104_08
21.11.2016 Teleflex Medical Europe

ARROW OnControl
Model see FSN
Lot: see FSN

MD: Bone marrow biopsy needle, single-use

de

fr

it

en

Vk_20161108_01
21.11.2016 AS Laerdal Medical

Update

Laerdal Suction Unit (LSU)
Model LSU w/Serres / LSU w/Reusable / LSU w/ Bemis / LSU w/Abbott; catalogue: 780000xx / 780030xx / 780020xx / 780030xx; Accessory: 780800 LSU NiMH Battery (all lots)
S/N: From 78451361071

MD: Electric emergency suction system

de

de - Update

fr

fr - Update

it

it - Update

Vk_20160803_02
14.11.2016 Medtronic Inc.

Update

SynchroMed II Implantable Pump
Model 8637-20, 8637-40

AIMD: General-purpose implantable infusion pump, programmable

de

de - Update

fr

fr - Update

it

it - Update

en

en - Update

Vk_20140318_24
14.11.2016 Nihon Kohden Corp.

cardioLife
Model AED-2100K

MD: Physiologic-monitoring defibrillation system

de

en

Vk_20161114_03
14.11.2016 Leonhard Lang GmbH

Defibrillation electrode SCHILLER DF87C and DF56C
Model: DF87C, DF56C, catalogue: 0-21-0040, 2.155065
Lot: all

 

DEFIGARD TOUCH7

MD: Electrodes, Cardiac, External Defibrillator; Defibrillator/monitor

de

en

Vk_20161028_08
14.11.2016 Quidel Corporation

MicroVue Intact PTH EIA
Model 8044
Lot: see letter

IVD: Parathyroid Hormone intact

en

Vk_20161101_04
14.11.2016 IMPAC Medical Systems Inc.

Monaco RTP System
Software Version: 5.11, 5.20

MD: Radiation therapy application software

de

fr

it

en

Vk_20161101_06
14.11.2016 Bosch + Sohn GmbH & Co KG

boso TM-2430 PC2

MD: Blood pressure long-term ambulatory recorder

de

en

Vk_20161102_14
14.11.2016 S.I.M.E.O.N. Medical GmbH & Co. KG

Suspension system for surgical lights
Model e.g. for Sim.LED 5000/7000 SC/MC
S/N: central axis systems produced between 01.03.2014 and 30.04.2016

MD: Operating/examination/treatment light mount, fixed

de

en

Vk_20161102_15
14.11.2016 Hologic Inc.

ATEC Canister
Lot: 20150013, 20150014

MD: Mammographic stereotactic biopsy system

en

Vk_20161102_12
14.11.2016 Stryker Trauma Kiel

GAM Kirschner Wire
Model 12106450S
Lot: see FSN

 

T2 K-Wire
Model 18060050S
Lot: see FSN

 

T2 K-Wire Recon
Model 18063030S
Lot: see FSN

MD: Bone nail guidewire

de

fr

it

Vk_20161101_02
14.11.2016 CareFusion

V. Mueller Shadow-Line Spinal Distraction Screw
Model S-0088; S-0089; S-0090; S-0091
Lot: see FSN

MD: Spinal bone screw, non-bioabsorbable

en

Vk_20161104_05
14.11.2016 Atrium Medical Corporation

Thoracic Catheters
Model 8408, 8410, 8412, 8416, 8420, 8424, 8428, 8432
Lot: All since Sept 2011

MD: Pleural catheter

de

fr

en

Vk_20161107_02
07.11.2016 Biomet UK Ltd

Rebalance Ankle Talar Culcus Guides
Model 407775, 407776, 407777, 407778, 407760
Lot: FS72117, FS72400, FS71394, FS69451, FS72119, FS71831, FS71397, FS72403, FS71400, FS74140, FS73505

MD: Orthopaedic reamer guide

en

Vk_20161031_01
07.11.2016 Boston Scientific Corporation

Lotus Edge Valve System
Model see FSN
Lot: all

MD: Transcatheter heart valve bioprosthesis, stent-like framework

de

en

Vk_20161031_03
07.11.2016 GE Medical Systems S.A.

Innova
Model 2100IQ, 3100, 3100IQ, 4100, 4100IQ
S/N: See FSN

MD: Chest-oscillation airway secretion clearing system vest

de

fr

it

en

Vk_20161026_08
07.11.2016 Albomed GmbH

Pe-Ha-Visco / Pe-Ha-Luron F / i-Visc / Hexavisc / Naluron / Viscophta / Polyhyl / Argon-Visc / Viscosert M
Lot: P170A, O277C, O167A

MD: Vitreous/aqueous humour replacement medium, intraoperative

en

Vk_20161028_05
07.11.2016 Siemens Healthcare Diagnostics Inc.

ADVIA Centaur CA 19-9
Model 10491244, 10491379

IVD: CancerxA0antigenxA019-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

de

fr

en

Vk_20161027_03
07.11.2016 Medline International France SAS

Sterile Procedure Trays containing Devon Light Gloves

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

de

Vk_20161026_07
07.11.2016 Trinity Biotech plc

MicroTrak Syphilis TPHA
Model 8H60120, 8H60121, 8H60122
Lot: see letter

IVD: Reagent, syphilis-reagin antibody

de

en

Vk_20161026_06
07.11.2016 Orion Diagnostica

QuikRead go Instrument
Model 136189
Software Version: 7.1.10

 

QuikRead go iFOBT

IVD: INSTRUMENTS , CONSUMABLES, SPARE PARTS, SOFTWARE, SERVICE; Faecal occult blood IVD, kit, nephelometry/turbidimetry

de

fr

it

en

Vk_20161026_02
07.11.2016 ACUTRONIC Medical Systems AG

Update

Fabian HFO

MD: Ventilator

e1

e2 - Update

Vk_20161020_04
07.11.2016 Invacare Rea AB

Rollator Dolomite Futura
Model see FSN
S/N: 12L02002334, 12L02002335, 12L02002336, 12L02002337, 12L02002338, 12L02002339, 12L02002340, 12L02002341, 12L02002342, 12L02002343, 12L02002344, 12L02002345

MD: Basic walker, non-foldable

de

Vk_20161025_06
07.11.2016 Invacare Portugal, Lda

Invacare Birdie
Model all
S/N: all

MD: Mobile patient lifting system, battery-powered

de

fr

it

Vk_20161101_01
07.11.2016 Bausch & Lomb Inc.

EasySept Hydro Plus Peroxide Solution and PeroClean
Model EasySept Hydro Plus
Lot: all lots

MD: Contact lens care kit

de

de - Update

fr

it

en

Vk_20161028_16
07.11.2016 Teleflex Medical

LMA MAD Nasal Intranasal Mucosal Atomization Device
Model see FSN
Lot: see FSN

MD: Atomizer

de

fr

it

en

Vk_20161028_15
07.11.2016 Cepheid AB

Xpert MRSA Blood culture assay
Model GXMRSA-SA-BC-CE-10
Lot: 1000025828 ( cartridge lot 12803)

IVD: MRSA/MSSA nucleic acid detection IVD, kit, nucleic acid technique (NAT)

de

fr

it

en

Vk_20161028_14
07.11.2016 Teleflex Medical

LMA Mucosal Atomization Devices
Model see fsn
Lot: see fsn

MD: Atomizer

de

fr

it

en

Vk_20161031_02
07.11.2016 Biomerica, Inc.

Intact PTH ELISA Kit
Model 7022, 7022BU
Lot: 2488, 2494, 2494B

IVD: Parathyroid Hormone intact

de

fr

it

en

Vk_20161025_03
07.11.2016 Trinity Biotech plc

MicroTrak RPR Syphilis
Model see letter
Lot: see letter

IVD: Syphilis-treponemal total antibody kit

en

Vk_20161102_02
07.11.2016 Beckman Coulter, Inc.

Access Ostase
Model 37305, B83876 (Calibrators); 37309, B83877 (QC)
Lot: See FSN

IVD: Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay

fr

en

Vk_20161024_12