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
19.06.2017 CENTRE EUROPEEN DE BIOTECHNOLOGIE (CEB) SA

FLACON POUR ULTRA-TURRAX AVEC BILLES ET EAU BIO MOL STERILE
Model UTX001
Lot: 625703, 0163626, 0163627, 0163669, 0163670, 0163728

IVD: Sterile solution bottle, single-use

de

fr

en

Vk_20170608_09
19.06.2017 Zimmer Inc.

Zimmer Plates and Screws, Zimmer Universal Locking
Model see FSN
Lot: see FSN

MD: Orthopaedic prosthesis implantation instrument, reusable

de

fr

it

Vk_20170607_12
19.06.2017 Biomet Orthopedics LLC

Comprehensive Nano Humeral Component PPS
Model 115730, 115732, 115734, 115736, 115738, 115740
Lot: All

MD: Coated shoulder humeral stem prosthesis

en

Vk_20170607_07
19.06.2017 Leica Biosystems Nussloch GmbH

ASP6025 Tissue Processor
Model 14049543267,14049543268,14049549361
S/N: 163, 169, 200-821, 823-895, 897-899, 901-1123 (all odd - serial numbers)

IVD: Tissue processor

en

Vk_20170609_32
19.06.2017 Abbott - Thoratec Corporation

Heartmate III
Model 106524/ 106524INT , 10001696/ 10001696INT

AIMD: Implantable ventricular circulatory assist system

en

Vk_20170608_02
19.06.2017 Siemens Healthcare Diagnostics Products GmbH

N Protein Standard SL; N/T Protein Control SL
Model N Protein Standard SL; OQIM13, SMN 10446073; N/T Protein Control SL/L, OQIN13, SMN 10446076; N/T Protein Control SL/M, OQIO13, SMN 10446082; N/T Protein Control SL/H, OQIP13, SMN 10446086
Lot: see letter

IVD: Plasma protein IVD, calibrator

de

fr

en

Vk_20170606_20
19.06.2017 Draeger Medical Systems, Inc.

Infinity Acute Care System
Model MK31501/MK31701/MK31722

MD: Single-patient physiologic monitoring system

de

Vk_20170609_03
19.06.2017 Intuitive Surgical, Inc

da Vinci Xi Surgical System
Model IS4000
S/N: SK0822; SK1001; SK1040; SK1146; SK1190 ; SK1082; SK1154; SK1170: SK1176; SK1180

MD: Robotic surgical system

en

Vk_20170602_01
19.06.2017 Toshiba Medical Systems Corporation

Diagnostic Ultrasound System
Model US-X100, TUS-X200, TUS-A300, TUS-A400, TUS-A500, TUS-AI700, TUS-AI800, TUS-AI900, TUW-U001, TUW-U001S

MD: General ultrasound imaging system, line-powered

de

fr

it

en

Vk_20170607_01
19.06.2017 Biomet Orthopaedics, LLC

Affixus Hip Fracture Nail
Model see fsn
Lot: All lots beginning with "D"

MD: Femur nail, sterile

de

fr

it

Vk_20170609_02
12.06.2017 Drägerwerk AG & Co.KGaA

DIN CO2-Stecker und DIN 02-Entnahmestelle

MD: Medical gas outlet

de

Vk_20170609_37
12.06.2017 Medela AG

AXS Universal Aspiration TubingModel 077.0193
Lot: 116359

MD: Suction system tubing

fr

en

Vk_20170529_36
12.06.2017 Bio-Rad France

Monolisa HCV Ag-Ab ULTRA V2 assay (1 Platte - 96 Tests)
Model 72561
Lot: 6J0029;6K0030;6K0031;6M0032;740033

 

Monolisa HCV Ag-Ab ULTRA V2 assay
Model 72562
Lot: 6J0533;6K0534;6K0535;6M0536

IVD: Hepatitis C virus antibody/antigen IVD, kit, enzyme immunoassay (EIA)

de

Vk_20170522_07
12.06.2017 Beckman Coulter Ireland, Inc.

DxH 500
Model B40601
Software Version: Version 1.0.2

IVD: Haematological cell analyser IVD, automated

de

fr

it

en

Vk_20170606_02
12.06.2017 EOS imaging

MOBELI Stabi Vario in Verwendung mit EOS Systemen
Model ROTH Katalognr. 14002 96 S / EOS imaging Katalognr. 9000111773

 

MOBELI Dual Grip in Verwendung mit EOS Systemen
Model ROTH Katalognr. 14002 25 S / EOS imaging Katalognr. 9000111774

MD: therapy aid to help stabilize and guide patient's arm

MD: portable suction grab bar with a fixed length

de

Vk_20170601_04
12.06.2017 Siemens Healthcare Diagnostics Products GmbH

Dimension Vista PROT1CAL & PROT1 CON ( L & M & H)
Model Dimension Vista PROT1 CAL, KC710, SMN 10469516; Dimension Vista PROT1 Con L, KC715, SMN 10445919; Dimension Vista PROT1 Con M, KC716, SMN 10445920; Dimension Vista PROT1 Con H, KC717, SMN 10445
Lot: see letter

IVD: Plasma protein IVD, calibrator

de

fr

en

Vk_20170601_05
12.06.2017 SENTINEL CH SpA

Creatinine (Enzymatic)
Model 8L24-31, 8L24-41
Lot: 60335Y600, 60382Y600, 60334Y600

IVD: Creatinine IVD, reagent

de

fr

en

Vk_20170601_01
12.06.2017 Alcon Laboratories Inc.

LuxOR / LX3 Microscope Floor Stand
Model 8065752560

MD: Ophthalmic slit lamp, surgical

de

fr

en

Vk_20170531_15
12.06.2017 Terumo CORPORATION

Radifocus Introducer II
Model See FSN
Lot: See FSN

 

Radifocus Introducer II M coat
Model See FSN
Lot: See FSN

 

Glidesheath Slender
Model See FSN
Lot: See FSN

MD: Catheter introducer

de

fr

it

en

Vk_20170602_10
12.06.2017 ArjoHuntleigh AB

Flowtron ACS900
Model 526000-03, 526000-04, 526000-07, 526000-08, 526000-09, 526000-10;n/a
S/N: Devices with software V1.099 manufactured from Sep 26, 2014 through Dec 20, 2016 Range of affected serial numbers: 1400028031 to 1600048470
Lot: /
Software Version: 1.099

MD: Intermittent venous compression system

en

Vk_20170606_07
12.06.2017 Medtronic MiniMed

Medtronic MiniMed 640G Insulin Pump
Model MMT-1711, MMT-1712
S/N: All

MD: Ambulatory insulin infusion pump

de

fr

it

en

Vk_20170529_07
12.06.2017 Angiomed GmbH & Co. Medizintechnik KG

SBK Cut Biopsy Needle / MS-cut
Model 17030050, 17030070, 17030080, 17030100
Lot: See FSN

MD: Soft-tissue biopsy needle, single-use

de

en

Vk_20170601_11
12.06.2017 Zimmer Inc.

Trauma Implants
Model See FSN
Lot: All lots with expiry date prior to May 2027

MD: Orthopaedic fixation plate, non-bioabsorbable, sterile

de

fr

it

en

Vk_20170601_13
12.06.2017 Medtronic Sofamor Danek USA, Inc.

Kyphon Directional Bone Filler
Model F04C

MD: Orthopaedic cement dispenser

dt

fr

en

Vk_20170518_04
12.06.2017 Hitachi High-Technologies

Update

cobas 8000 ISE module 900 / 1800
Model see letter
S/N: see letter

 

cobas c 311 / 501 / 502 / 701 / 702
Model see letter
S/N: see letter

IVD: Ion-selective analyser IVD, automated; Laboratory multichannel clinical chemistry analyser IVD, automated

de

de - Update

fr

fr - Update

it

en

en - Update

Vk_20170308_12
12.06.2017 Haemonetics Corporation

Update

Cell Saver Elite Processing Kit (225 mL)
Model CSE-P-225
Lot: 1115013; 1115100

MD: Blood-processing autotransfusion system set

de - 2

de - 3

fr -1

fr - 2

fr - 3

en - 1

en - 2

en - 3

Vk_20160418_03
06.06.2017 Philips Medical Systems DMC GmbH

DigitalDiagnost
Model 712026
Software Version: 3.1.x

MD: Stationary basic diagnostic x-ray system, digital

de

fr

en

Vk_20170523_06
06.06.2017 Reha Technology AG

G-EO System
Model G-EO System;RTGS3200
S/N: 2011-01 bis 2016-73

MD: Treadmill/elliptical gait rehabilitation system, automated-guidance

de

en

Vk_20170529_27
06.06.2017 Siemens Healthcare Diagnostics Inc.

RAPIDLab 348 / RAPIDLab 348EX Gas cartridge pack
Model 10309768
Lot: 5260XX through 7020XX

IVD: Multiple blood gas analyte IVD, calibrator

de

fr

en

Vk_20170524_10
06.06.2017 Beckman Coulter, Inc.

PrepPlus 2 and PrepPlus Sample Preparation Systems
Model 378600, 286600
S/N: All
Software Version: 2.04 and 1.00

IVD: Specimen processing instrument IVD, automated

fr

en

Vk_20170529_14
06.06.2017 Philips Medical Systems

Philips IntelliVue NMT Patient Cables
Model Philips IntelliVue NMT Patient Cables (989803174581)

MD: Contraceptive

de

fr

en

Vk_20170529_17
06.06.2017 ERBE Elektromedizin GmbH

ERGO handle - ERGO-Griffstamp; r BiClamp E LAP-Zang
Model 20195-240, 20195-245
Lot: OP271317 (20195-240)xA;OP272560 (20195-240)xA;OP269409 (20195-245)

MD: Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

en

Vk_20170424_06
06.06.2017 Hamilton Medical AG

lntelliCuff Standalone
Model 951001
S/N: 1000-2090

MD: Tracheal Tube Cuff Inflators

de

fr

it

en

Vk_20170524_09
06.06.2017 Exactech Inc.

Equinoxe Modular and Non-Modular Pilot Tip Reamers
Model 321-25-01, 321-25-38, 321-25-42, 321-25-46, 321-45-01, 321-45-38, 321-45-42, 321-45-46, 321-05-01, 321-05-38, 321-05-42, 321-05-46

MD: Orthopaedic prosthesis implantation instrument, reusable

de

fr

it

Vk_20170529_16
06.06.2017 GE / OEC Medical Systems Inc.

OEC Elite

MD: Mobile general-purpose fluoroscopic x-ray system, digital

en

Vk_20170529_06
06.06.2017 Bentley InnoMed GmbH

BeGraft Peripheral Plus Stent Graft System
Model BGP+2707_2BGP+3707_2BGP+5707_2BGP+2708_2BGP+3708_2BGP+5708_2
Lot: All LOT numbers of the above mentioned catalogue numbers

MD: Stent Graft System

de

fr

en

Vk_20170529_04
06.06.2017 Carestream Health Inc

DRX-Revolution Mobile X-Ray System

MD: Mobile basic diagnostic x-ray system, digital

de

fr

it

en

Vk_20170529_34
29.05.2017 Millipore (UK) Ltd

Bioscot Anti-M Monoclonal Murine IgG Blood Grouping Reagent
Model see letter
Lot: see letter

IVD: Anti-M red blood cell grouping IVD, antibody

de

en

Vk_20170519_08
29.05.2017 Cook Incorporated; Cook Ireland Limited

Willscher Vas Reapproximator Set
Model 092000 - G14500
Lot: All

 

Willscher Vas Skewers
Model 092001 - G14512
Lot: Alkl

 

Willscher Vas Reapproximator Plate
Model 092002 - G15612
Lot: All

 

Endoscopic Curved Needle Driver
Model 096511 - G15573; J-ENH-033100 - G16426; J-ENH-053100 - G16427; J-ENH-053120 - G16428J-ENH-053130 - G16429
Lot: All

 

LapSac Introducer Set
Model 054300
Lot: All

 

LapSac Introducer
Model J-LSI-102500
Lot: All

MD: Imaging lesion localization marker, implantable; Gastro-urological suturing needle; Tissue extraction bag introducer

de

fr

en

Vk_20170519_02
29.05.2017 Unomedical Inc

Oxygen Masks
Model 104MM; 106MM; 108-E; 108MM; 3226-E; 3226MM; 3230MM; 9108MM
Lot: Please see FSN

MD: Non-rebreathing oxygen face mask, rebreathing oxygen face mask

de

fr

it

en

Vk_20170519_01
29.05.2017 Zimmer GmbH

Werber Countersink Cannulated for micro CBS screws
Model 503004341; 503004541
Lot: 13015; 13016; 13571; 14341; 14482; 14570; 13065; 13569; 15350

MD: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

de

fr

it

en

Vk_20170529_03
29.05.2017 Roche Diagnostics GmbH

cobas p 512 pre-analytical system
Model 07563124001
Software Version: all

 

cobas p 612 pre-analytical system
Model 07563116001
Software Version: all

IVD: Specimen processing instrument IVD, automated

de

fr

en

Vk_20170519_14
29.05.2017 BioMérieux Inc.

VITEK 2 AST-GN colistin
Model see letter
Lot: all

IVD: General-microorganism antimicrobial susceptibility culture medium IVD

de

fr

en

Vk_20170522_05
29.05.2017 Abbott - Thoratec Corporation

Heartmate III
Model 106524INT - LVAS KIT, HM 3105581I Packaged assembly Outflow, HM3(INT)

AIMD: Implantable ventricular circulatory assist system

de

fr

it

en

Vk_20170518_12
29.05.2017 Respironics California Inc (Philips)

V60 Ventilator
Model 850008
S/N: All V60 manufactured from 4 April 2009 to 14 September 2015

MD: Ventilator

de

fr

en

Vk_20170519_12
29.05.2017 Datex Ohmeda

Carestation 650c

 

Carestation 650

 

Carestation 620

MD: Anaesthesia workstation, general-purpose

de

fr

it

en

Vk_20170517_02
29.05.2017 Wing Plast AB

Proctoscope
Model 1541
Lot: 8608

MD: Proctoscope

en

Vk_20170425_14
29.05.2017 Medline International France SAS

SECTIO SET
Model ZGZMA061AZGZMA061A, ZGZMA061A
Lot: 654770, 656377, 659963, 661307

MD: Procedure Tray containing Polyglactin Suture

de

Vk_20170516_10
29.05.2017 STEPHANIX

D2RS
S/N: all

MD: Basic diagnostic x-ray system table, powered

de

fr

en

Vk_20170522_06
29.05.2017 Medtronic Navigation Inc.

NavLock Tracker (part of NavLock instrument sets)
Model 9734228, 9734259, 9734315, 9734489, 9734590, 9734682, 9734683, 9734734, 9734833, 9734837, 9734906, 973490 7,9734908, 9734 9735120
S/N: All

MD: Multi-purpose stereotactic surgery system

en

Vk_20170517_03
29.05.2017 Mölnlycke Health Care AB

Update

Brennen Skin Graft Mesher
Model 131600, 131601, 131602, 131603, 131604, 131500, 131501, 131502, 131503, 131504, 131506

MD: Skin graft mesher

de

de - Update

en

en - Update

Vk_20170428_09
23.05.2017 Joh. Stiegelmeyer GmbH & Co. KG

Sicuro Plus
Model: 5369, Catalogue: 146562; 114787
S/N: all

MD: Bed, electric

de

Vk_20170425_11
23.05.2017 Covidien llc

POLYSORB suture
Model See FSN
Lot: See FSN

 

Endo Stitch
Model see FSN
Lot: see FSN

 

Maxon Monofilament Absorbable Suture
Model see FSN
Lot: see FSN

 

Biosyn Suture
Model see FSN
Lot: see FSN

MD: Polyglactin suture; Suture knot-tying device; Polyglyconate suture

de

fr

en

Vk_20170510_04
23.05.2017 ArcRoyal Ltd

Inflation Device 30 atm

MD: Catheter-balloon inflator, single-use

de

fr

it

en

Vk_20170510_02
23.05.2017 KCI USA, Inc

1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems
Model M8275093/5
Lot: see letter

MD: Negative-pressure wound therapy system canister

de

en

Vk_20170509_07
23.05.2017 MEDTECH

ROSA Brain
Model ROSA Brain 3.0.0
S/N: BR16027

MD: Neurological stereotactic surgery system

fr

en

Vk_20170515_04
23.05.2017 Covidien llc

Endo Peanut Auto Suture Blunt Dissector 5mm
Model 173019 (for affected kits see fsn)
Lot: M5K04X to M7A01X (for affected kits see fsn)

MD: Laparoscopic blunt dissector

de

fr

it

en

Vk_20170516_03
23.05.2017 Elekta Instrument AB

Leksell Gamma Knife Icon
Model 1515698
S/N: 6018, 6047, 6090, 6094, 6171, 8018

MD: Teletherapy radionuclide system

de

fr

en

Vk_20170511_02
23.05.2017 Balt Extrusion

SONIC1.5F

MD: Intravascular microflow catheter

de

fr

en

Vk_20170511_08
23.05.2017 Roche Diagnostics GmbH

cobas 6800 System
Model 05524245001
Software Version: SW 01.00.12, SW 01.01.09, SW 01.01.10, SW 01.02.12

 

cobas 8800 System
Model 05412722001
Software Version: SW 01.00.12, SW 01.01.09, SW 01.01.10, SW 01.02.12

 

Cobas MPX

 

cobas DPX Test

IVD: Thermal cycler nucleic acid amplification analyser IVD, automated; HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT); Others Virus Combination - Multiplex NA Reagents

de

fr

en

Vk_20170516_02
23.05.2017 Vascular Solutions Inc.

Venture RX Catheter, Venture OTW Catheter, and Venture CS Catheter
Model 5820, 5821, 5822
Lot: see fsn

MD: Peripheral/coronary vascular infusion catheter

de

fr

en

Vk_20170505_01
23.05.2017 BioMérieux Inc.

Update

VITEK 2 GN ID, VITEK 2 GP ID, VITEK 2 YST ID, VITEK 2 BCL ID, VITEK 2 NH ID, VITEK 2 ANC ID, VITEK 2 AST
Model see letter
Lot: see letter

IVD: MICROBIOLOGY (CULTURE)

de

de - Update

fr

fr - Update

en

en - Update

Vk_20170421_17