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
18.04.2017 Autonomic Technologies Inc. (ATI)

Pulsante SPG Microstimulator System
Model NS-100, RC-200, SI-100-E, SI-110-E, SI-120-E, LB-100-E, PS-100
Lot: All lots manufactured after November, 2010
Software Version: 0.5.9.0

AIMD: Neurosurgical procedure kit, non-medicated, single-use

de

en

Vk_20170410_02
18.04.2017 Siemens Healthcare Diagnostics Inc.

RapidPoint 500
Model 10697306
S/N: 40412, 40457, 40458, 40459, 40460, 40461, 40463, 40466, 40467, 40468, 40469, 40470, 40471, 40472, 40508, 40509, 40510, 40512, 40561, 40562, 40565, 40594, 40596, 40649, 40650, 40651, 40652, 40656
Software Version: V2.4B

IVD: Blood gas/pH/electrolyte/metabolite analyser

fr

Vk_20170405_05
18.04.2017 Natus Medical Incorporated

neoBLUE LED Phototherapy System
Model 010066, 010068, 010069, 010070
S/N: 2. generation neoBLUE LED Phototherapy Systems sold from 2003 to 2008
Lot: 10500 to 17919

MD: Overhead infant phototherapy unit

de

fr

en

Vk_20170405_03
18.04.2017 Newport Medical Instruments, Inc.

Newport HT70 Ventilators
Model see FSN

MD: Neonatal/adult intensive-care ventilator

en

Vk_20170406_02
18.04.2017 Olympus Medical Systems Corp.

Flexible Video Duodenoscope
Model N4497430

MD: Flexible video duodenoscope

en

Vk_20170410_03
18.04.2017 bioMérieux SA

Etest ERTAPENEM ETP 32
Model 531640, 531600
Lot: see FSN

IVD: Ertapenem minimum inhibitory concentration (MIC) IVD

de

fr

en

Vk_20170406_01
18.04.2017 Perouse Medical (Ivry Le Temple Plant)

Dolphin Inflation device / Caliber Inflation Device
Model 0185NA ; 0185ND ; 0185NR ; 0185PD ; 0185QL ; 0185TD ; 0185TS ; CL3030 (Caliber)
Lot: All batches numbers (8 digits) beginning by: 1504XXXX to 1512XXXX, 1601XXXX to 1612XXXX

MD: Catheter-balloon inflator, single-use

fr

en

Vk_20170406_05
18.04.2017 Arrow International Inc

ARROW Kits with BD Eclipse Needles
Model see FSN
Lot: see FSN

MD: Central Venous Catheter; Haemodialysis Catheter, Non-implantable; Peripheral vascular infusion/aspiration catheter; Peripherally-inserted central venous catheter; Vascular catheter introduction kit; Vascular catheterization support kit

en

Vk_20170410_10
18.04.2017 Sorin Group Italia Srl

Paradym

 

Intensia

 

Ovatio

AIMD: Dual-chamber implantable defibrillator; Cardiac resynchronization therapy implantable defibrillator; Single-chamber implantable defibrillator

de

fr

it

en

Vk_20170410_07
18.04.2017 St. Jude Medical CRMD

Merlin@Home Transmitter
Model EX1150, EX1150W, EX1100, EX1100W
S/N: All
Software Version: 8.2.2

AIMD: Transtelephonic implantable pacemaker analysis system

de

fr

it

en

Vk_20170404_01
18.04.2017 Ortho Clinical Diagnostics Inc.

Update

VITROS Chemistry Products Na+ Slides
Model 8379034

IVD: Sodium (Na+) IVD, reagent

de - 1

de - 2

fr - 1

fr - 2

en - 1

en - 2

Vk_20170103_02
18.04.2017 Stryker Orthopaedics

Update

LFIT Anatomic CoCr V40 Femoral Heads
Model see FSN
Lot: lots manufactured since 01 January 2002 to 04 March 2011

MD: Metallic femoral head prosthesis

de

de - Update

fr

fr - Update

it

it - Update

Vk_20160928_01
10.04.2017 Cepheid AB

Xpert CT/NG
Model GXCT/NG-CE-10, GCXCT-CE-10
Lot: 1000043096, 1000044234, 1000043097

IVD: Multiple sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

de

en

Vk_20170403_09
10.04.2017 Nexstim Plc

Nexstim NBS System
Model 4, 5
S/N: All serial numbers starting from 10271241N4 (manufactured in July 2010) until today
Software Version: 4.0 or higher, 5.0 or higher

MD: Stereotactic neuronavigation/planning system

de - 1

de - 2

Vk_20170403_08
10.04.2017 Philips Medical Systems Nederland BV

Allura Xper Systems, CV2O Systems and UNIQ systems
Model see letter

MD: Stationary general-purpose fluoroscopic x-ray system, analogue

de

fr

it

en

Vk_20170331_04
10.04.2017 Mizuho OSI

Wilson Frame Pads
Model 5319-37 / GTIN: 00842430100192
Lot: Mfr dates 2016-12-01 through 2017-03-20

MD: Operating table mattress

de

fr

it

en

Vk_20170331_02
10.04.2017 Abbott - Thoratec Corporation

HeartMate II LVAS System Controller
Model 105109, catalogue: 106016 and 106017
S/N: all
Software Version: 7.29

AIMD: Implantable ventricular circulatory assist system control unit

de

fr

it

en

Vk_20170330_06
10.04.2017 Biomet France SARL

Vanguard ROCC; Vanguard Alpina; Alpina APS; Alpina APR; Alpina Uni; Exception stem; Avantage cup
Model see fsn
Lot: see fsn

MD: various prostheses & components

de

en

Vk_20170330_04
10.04.2017 Soluscope SAS

SOLUSCOPE endoscope washer-disinfector
Model Soluscope Serie 3 GTA, catalogue: 5076
S/N: 23352
Software Version: 1.31

MD: Flexible endoscope washer

fr

Vk_20170330_01
10.04.2017 Aesculap AG & Co. KG

Diamond Burr, single-use
Model see FSN
Lot: all

 

Diamond Burr, reusable
Model see FSN
Lot: all

MD: Orthopaedic bur, single-use



MD: Orthopaedic bur, reusable

de

en

Vk_20170329_07
10.04.2017 bioMérieux SA

ETEST OX 256 (OXACILLIN)
Model 520558, 520518
Lot: see letter

IVD: Oxacillin minimum inhibitory concentration (MIC) IVD

de

fr

en

Vk_20170329_05
10.04.2017 GE Vingmed Ultrasound AS

Vivid
Model E80, E90, E95, S60N, S70N, S60, S70
Software Version: 201.54, 201.55, 201.61, 201.63

MD: Cardiovascular ultrasound imaging system

de

fr

it

en

Vk_20170329_06
10.04.2017 Abbott Vascular Inc.

ABSORB Bioresorbable Vascular Scaffold System
Model 1012462-08, 1012462-12, 1012462-18, 1012462-23, 1012462-28, 1012463-08, 1012463-12, 1012463-18, 1012463-23, 1012463-28, 1012464-12, 1012464-18, 1012464-23, 1012464-28
Lot: all

 

ABSORB GT1 Bioresorbable Vascular Scaffold System
Model 1234250-08, 1234250-12, 1234250-18, 1234250-23, 1234250-28, 1234300-08-1234300-12, 1234300-18, 1234300-23,1234300-28, 1234350-12, 1234350-18, 1234350-23, 1234350-28
Lot: all

MD: Drug-eluting coronary artery stent, fully-bioabsorbable

de

fr

it

en

Vk_20170329_03
10.04.2017 Beckman Coulter, Inc.

Access 2 Immunoassay System
Model see FSN
S/N: see FSN

 

UniCel DxC 600i System
Model see FSN
S/N: see FSN

IVD: Chemiluminescent immunoassay analyser IVD, automated; Laboratory multichannel clinical chemistry analyser IVD, automated

de

Vk_20170307_05
10.04.2017 SEJONG MEDICAL CO., LTD.

Laport-L
Model N53-0510
Lot: 2016.07.08

MD: Laparoscopic sleeve

de

Vk_20170330_05
10.04.2017 CareFusion Switzerland 317 Sàrl

Alaris syringe driver
Model see fsn
Lot: all

MD: Syringe pump

de

fr

it

en

Vk_20170228_06
03.04.2017 William Cook Europe ApS

Zenith Alpha Thoracic Endovascular Graft
Model See FSN

MD: Synthetic vascular graft

en

Vk_20170322_05
03.04.2017 MEDTECH

ROSA
Model Brain 3.0.0, One 3.1.0, Spine 1.0.2
S/N: BR15003, BR15002, BR16027, BR16019, BR16020, BR16026, BS16001, SP16008, BR16005, BR16004, BR16006, BR16012, BR16011, BR16009, BR16010, BR16014, BR16013, BR16015, BR16021, BR16017, BR16018, BR16016, BR16023, BR16025

MD: Neurological stereotactic surgery system

fr

en

Vk_20170322_01
03.04.2017 Zimmer Biomet

Femoral IM Nail
Model see fsn
Lot: Lot Number Expiry Date Before March 2027

 

Segmental Stem; Porous stem
Model see fsn
Lot: see fsn

MD: Femur nail, sterile; Knee stem

de

fr

it

en

Vk_20170321_03
03.04.2017 Cook Incorporated

Bush DL/SL Ureteral Illuminating Catheter Set
Lot: See FSN

MD: Fibreoptic ureteral catheter, single-use

de

Vk_20170327_04
03.04.2017 Philips Medical Systems (Cleveland) Inc

BrightView

 

BrightView XCT Imaging System

 

BrightView X

MD: Stationary gamma camera system; PET/CT system

de

fr

en

Vk_20170324_04
03.04.2017 Draeger Medical Systems, Inc.

Delta XL
Model MS18596
Software Version: VF10.0

 

Kappa
Model MS18853
Software Version: VF10.0

 

Delta
Model MS18597
Software Version: VF10.0

MD: Patient monitoring system; Monitoring Systems, Physiologic

de

Vk_20170327_01
03.04.2017 Biomet UK Ltd

Oxford Unicompartmental Cementless Tibial Trays
Model see FSN
Lot: all

MD: Unicondylar knee prosthesis

de

fr

it

en

Vk_20170323_04
03.04.2017 Bracco Injeneering S.A.

CT Exprès Contrast Injection System, Model Temperature Maintainer
Model; 650207, 650208
S/N: T0030016-0516 to T0030299-0117

MD: CT contrast medium injection system, line-powered, mobile

de

fr

it

en

Vk_20170328_01
03.04.2017 Philips Healthcare

MX40
Model 865352

MD: Single-patient physiologic monitoring system

de

en

Vk_20170327_15
03.04.2017 Schaerer Medical AG

schaerer arcus
Model arcus 501/601/701
S/N: AR-4828; AR-4839; AR-4841; AR-4846; AR-4847; AR-4848; AR-4854

MD: Universal operating table, electrohydraulic

de

fr

en

Vk_20170327_09
03.04.2017 SMEDICO AG

SAMA Steril Set
Model SIS2077-10, SIS2095-08, SIS2096-08, SIS2097-06, SIS2097-07, SIS2303-02

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

de

Vk_20170315_08
03.04.2017 Medtronic MiniMed

Medtronic MiniMed 640G Insulin Pump
Model MMT-1711, MMT-1712
S/N: all with software version 2.6
Software Version: 2.6

MD: Ambulatory insulin infusion pump

de

fr

it

en

Vk_20170201_01
27.03.2017 Nobel Biocare AB

Multi-unit abutment Plus CC RP 2.5mm
Model 38882
Lot: 12076345

MD: Dental implant suprastructure, temporary, reusable

en

Vk_20170320_14
27.03.2017 Stryker Instruments

SmartLife Large Aseptic Housing
Model 7126-120-000
Lot: Not lot number related

MD: Rechargeable battery pack

en

Vk_20170320_02
27.03.2017 Medtronic Inc.

Deep Brain Stimulation (DBS) Lead Kits
Model 3387, 3389, 3391
Lot: All

AIMD: Neural-tissue electrical stimulation lead

de

fr

en

Vk_20170317_03
27.03.2017 Siemens Healthcare Diagnostics Inc

Ammonia Flex reagent cartridge
Model SMN 10711991, P/N DF119
Lot: all

IVD: Ammonia IVD, kit, enzyme spectrophotometry

de

fr

en

Vk_20170317_02
27.03.2017 ArcRoyal Ltd

ArcRoyal Custom Procedure Trays containing BD Plastipak 100 ml Syringe 10-005358
Model 10-005358

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

de

fr

en

Vk_20170320_11
27.03.2017 Tem Innovations GmbH

r ex-tem
Model 503-05
Lot: 21734044

IVD: Unclassifiable and Other Haemostasis Reagents

de

Vk_20170317_08
27.03.2017 Abbott Vascular Inc.

NC Trek RX Coronary Dilatation Catheter
Model See FSN
Lot: See FSN

MD: Coronary angioplasty balloon catheter, basic

de

fr

it

en

Vk_20170320_17
27.03.2017 Siemens Healthcare Diagnostics Inc

Dimension Vista 500 Intelligent Lab System, Dimension Vista 1500 Intelligent Lab System
Model Dimension Vista 500: SMN10488224; Dimension Vista 1500: SMN 10444802
Software Version: v3.6.2 SP1, v3.7

IVD: Laboratory multichannel clinical chemistry analyser IVD, automated

de

fr

en

Vk_20170316_09
27.03.2017 Salvia medical GmbH & Co. KG

elisa
Model 600, 800, 800 VIT
Software Version: 1.07.0, 1.07.1, 1.07.2, 1.07.3, 1.07.4

MD: Intensive care ventilator

de

en

Vk_20170316_08
27.03.2017 Roho, Inc., a subsidiary of The Roho Group, Inc.

ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology
Model See FSN
S/N: Serial numbers falling between A2920163 and A3185287

 

ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology
Model see FSN
S/N: Serial numbers falling between A2920163 and A3185287

MD: Wheelchair cushion

de

fr

it

en

Vk_20170315_11
27.03.2017 Philips Healthcare

HeartStart MRx Defibrillator/ Monitor
Model M3535A (M3535ATZ), M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9

MD: Defibrillator/monitor

de

fr

it

en

Vk_20170314_06
27.03.2017 Intuitive Surgical, Inc

EndoWrist Stapler Release Kit
Model 381215-02 ; 381384-01 ; 381389-01 ; 381395-01; 381381-01 ; 381385-01 ; 381390-01 ; 381401-01; 381382-01 ; 381386-01 ; 381391-01 ; 381402-01; 381383-01 ; 381387-01 ; 381393-01 ; 381403-01

MD: Surgical torque wrench

de

fr

en

Vk_20170307_10
27.03.2017 Siemens Healthcare GmbH

Artis system with wireless foot switch
Model 4787797, 4787805, 4787813

MD: Stationary angiographic x-ray system, digital

de

fr

it

en

Vk_20170320_06
27.03.2017 Paul Hartmann AG

Update

CombiSets containing Becton Dickinson 100ml Plastipak Catheter Tip syringe
Model 2482691, 2482692, 2482693, 2484631, 2484632, 2485611, 2488801, 2626192, 2626193, 2642021, 2668565, 2642021, 2668566
Lot: see FSN

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

de

de - Update

en

Vk_20170220_12
20.03.2017 1stQ GmbH

AddOn
Model A4SW00

MD: Anterior-chamber intraocular lens, pseudophakic

de

fr

en

Vk_20170309_02
20.03.2017 Covidien llc

Curity Sodium Chloride Dressing
Model 3339
Lot: see FSN

 

Curity Eye Pad
Model 2841
Lot: see FSN

MD: Sterile wound irrigation solution; Eye pad

de

fr

en

Vk_20170310_05
20.03.2017 Respironics California Inc

V60 Ventilator
Model 850008
Software Version: 2.20

MD: Ventilator

de

fr

en

Vk_20170308_03
20.03.2017 Gambro Lundia AB

Prismaflex System, Prismaflex 4.11, Prismaflex 5.0
Model 107493, 113082, 113874, 114489, 114870, 955052, 6023014700
S/N: All
Software Version: 4.11, 5.00, 6.10, 7.XX, 8.XX

MD: Haemodialysis system, institutional

de

fr

en

Vk_20170307_06
20.03.2017 CareFusion

Biopsy, Aspiration, Bone Marrow needles and kit

MD: Manometer Tray, Jamshidi Needle Biopsy, Illinois (TJ) Needle Aspiration, Jamshidi (TJ) Needle Bone Marrow, Thoracentesis/Paracentesis Kit

de

en

Vk_20170313_10
20.03.2017 Storz Karl GmbH & Co

FLIPPTACK, Fixationsbutton
Model 28729FT
Lot: 61603728, 61603837, 61603844, 61700023, 61700063, 61700154

MD: Orthopaedic bone screw, non-bioabsorbable, sterile

de

fr

it

Vk_20170313_08
20.03.2017 Zimmer CAS

iAssist Validation Tool/SmartTools Knee System
Model 20-8011-021-00
Lot: 130542A1;1405941;140146;140146-1;140147;140407A;140407A-1;140407B;140407-B-1;140860;140860-1;141035;150120;B150120;B150711

MD: Total knee prosthesis implantation guide-instrument kit

de

fr

it

en

Vk_20170313_04
20.03.2017 JJGC Industria e Comercio de Materiais Dentarios SA - NEODENT

CM Exact Intra oral scanbody
Model 108.139
Lot: 56390; 71065; 71069

MD: Dental implant suprastructure, temporary, single-use

en

Vk_20170308_19
20.03.2017 Sysmex Corporation

Automated Hematology Analyzer XN-L series
Model XN-550
S/N: All

IVD: Haematology analyser

de

fr

it

Vk_20170309_01
20.03.2017 Hitachi High-Technologies

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

fr

it

en

Vk_20170308_12
20.03.2017 Siemens Healthcare GmbH; Business Area Advanced Therapies

Artis Q/Q.zen
S/N: Artis Q systems with A100G generators

MD: Stationary angiographic x-ray system, digital

de

fr

Vk_20170308_11
20.03.2017 Paul Hartmann AG

Vivano Med Abdominal Kit
Model 4097201, 4097202, 4097203, 4097204
Lot: see fsn

MD: Negative-pressure wound therapy system dressing set

de

fr

Vk_20170309_08
20.03.2017 Physio-Control Corporation

LIFEPAK 1000 Defibrillator
Model 320371500XXX, 99425-000XXX

MD: Non-rechargeable public semi-automated external defibrillator

de

fr

it

en

Vk_20170307_12