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
25.07.2016 Thermo Fisher Scientific Microbiology Basingstoke

ThermoScientific Oxoid GC Agar Broth
Model CM0367 (B,R,T,Q)
Lot: see letter

IVD: Culture media, non-selective and differential

en

Vk_20160712_15
25.07.2016 TRUMPF Medizin Systeme GmbH + Co. KG

TruSystem 7500 SF/SB
Model 1717020; 1730732
S/N: see FSN

 

TrueSystem 7500 SM
Model 1717023
S/N: see FSN

 

TrueSystem 5500 SM
Model 1607822;
S/N: see FSN

 

SB ARTIS
Model 1501878
S/N: see FSN

 

TrueSystem 7000
Model 1604788, 1604786
S/N: see FSN

MD: Line-powered electromechanical operating table system; Battery-powered electromechanical operating table system; Universal operating table, electromechanical, battery-powered

de

fr

it

en

Vk_20160713_07
25.07.2016 Medivance

Arctic Sun Temperature Management System
Model 318-02, 318-02-02
Lot: NGZKY606, NGAP2009

MD: Circulating-fluid whole-body heating/cooling system control unit

de

en

Vk_20160713_06
25.07.2016 Intuitive Surgical, Inc.

IS4000 EndoWrist Stapler 45
Model 470298

 

IS4000 EndoWrist Stapler 30
Model 470430

 

IS4000 EndoWrist Stapler 30 Curved-Tip
Model 470530

MD: Endoscopic motorized cutting stapler

de

fr

en

Vk_20160714_04
25.07.2016 Peters Surgical

LAME ONDULEE DE DELBET (Delbet corrugated drain)
Model DESI 1; NART 2
Lot: NLOT 1, NLOT 2

MD: Closed-wound drain

fr

en

Vk_20160714_03
25.07.2016 bioMérieux SA

NucliSENS easyMAG Magnetic Silica
Model 280133
Lot: see letter

IVD: Nucleic acid extraction/isolation kit IVD

de

fr

en

Vk_20160712_05
25.07.2016 Synthes GmbH

Locking Screw Stardrive 2.4 mm, self-tapping, length 12 mm, TAN sterile
Model 412.812S
Lot: 9775771, 9724771

 

Locking Screw Stardrive 2.4 mm, self-tapping, length 12 mm, TAN
Model 412.812
Lot: 9744302, 9946065, 9699702, 9746853

MD: Orthopaedic bone screw, non-bioabsorbable, sterile; Orthopaedic bone screw, non-bioabsorbable, non-sterile

de

fr

it

en

Vk_20160718_04
25.07.2016 Natus Medical Incorporated

neoBLUE LED Phototherapy System
Model 010066, 010068, 010069, 010070
S/N: all devices and customers for the neoBLUE LED Phototherapy System from January 1, 2004 to present.

MD: Overhead infant phototherapy unit

de

fr

en

Vk_20160712_03
25.07.2016 Zimmer Orthopaedic Surgical Products

Zimmer Air Dermatome II
S/N: 00-8851-001-00, 00-8851-001-00, 00-8851-001-01, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851-204-00, 00-8851-215-00, 00-8851-215-00
Lot: All

MD: Dermatome, pneumatic

de

fr

it

en

Vk_20160713_10
25.07.2016 Thermo Fisher Scientific Microbiology Basingstoke

ThermoScientific Oxoid Columbia Blood Agar Base
Model CM0331 (B,R,S,T,U)
Lot: see letter

IVD: Culture media, non-selective and non-differential

en

Vk_20160712_14
25.07.2016 DiaSys Deutschland Vertriebs-GmbH

Ganestin
Model 40102, 40103

IVD: Prothrombin time ( Quick Test )

de

en

Vk_20160718_01
25.07.2016 Howmedica Osteonics Corp

Triathlon
Model Triathlon Modular Handle: 6541-4-808
Lot: see FSN

MD: Orthopaedic prosthesis implantation instrument, reusable

de

en

Vk_20160712_09
25.07.2016 Covidien llc

Valleylab Laparoscopic Electrodes
Model Refer to attachment A of the FSN
Lot: Refer to attachment A of the FSN

MD: Universal hand-controlled electrosurgical diathermy system conducting unit, single-use

en

Vk_20160715_01
25.07.2016 Philips Medical Systems Nederland BV

Allura Xper
Model 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722038, 722039, 722058, 722059
Software Version: R8.2

 

UNIQ
Model 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722038, 722039, 722058, 722059
Software Version: R 1.0

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

de

fr

it

en

Vk_20160713_05
25.07.2016 Philips Healthcare (Suzhou) Co.Ltd

DuraDiagnost
Model 712211, 712214
Software Version: 3.0.X (Rel. before 3.0.7); 4.0.X (Rel. bef. 4.0.6)

MD: Stationary basic diagnostic x-ray system, digital

de

en

Vk_20160713_04
25.07.2016 Roche Diabetes Care Spain SL

Update

Emminens eConecta
Software Version: v5.4HF12

IVD: Diagnostics & Clinical Interpretation Supporting Software

en - 1

en - 2

Vk_20160617_08
25.07.2016 Abbott Vascular Inc.

Update

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: Bioabsorbable coronary artery stent, drug-eluting

de - 1

de - 2

fr - 1

fr - 2

it - 1

it - 2

en - 1

en - 2

Vk_20151202_11
18.07.2016 Etac AS, Etac Supply Gjovik

Molift Air 205 & 3000
Model 2501205,2501300,2501210,2501310,2501215,2501315,2501220,2501320

MD: Mobile patient lifting system, battery-powered

de

fr

Vk_20160630_21
18.07.2016 Novacare GmbH

APM 440X
Lot: All delivered APM 440X since May 2015

MD: Mattress Systems, Low-Air-Loss

de

Vk_20160708_09
18.07.2016 Medtronic Xomed

NIM EMG Endotracheal Tube
Model 8229306, 8229307, 8229308, 8229506, 8229507, 8229508
Lot: All

MD: Electromyographic needle electrode, single-use

de

fr

en

Vk_20160630_07
18.07.2016 bioMérieux

VIDAS Estradiol II
Model 30431
Lot: all

IVD: Oestradiol kit

de

fr

en

Vk_20160708_07
18.07.2016 Roche Diagnostics GmbH

cobas b123 POC System
Model 05122279001; 05122287001

IVD: Blood gas/pH/electrolyte/metabolite analyser

de

fr

it

en

Vk_20160708_08
18.07.2016 Neurodan A/S

ActiGait(R) Implantable Drop Foot Stimulator
Model 453
Catalogue number: see FSN

AIMD: Gait-enhancement electrical stimulation system, implantable

de

fr

en

Vk_20160705_09
18.07.2016 MoNo chem-pharm Produkte GmbH

ULTRASTOP pro med.

MD: Endoscopic antifog solution

de

en

Vk_20160705_08
18.07.2016 Miele Werk Bürmoos GmbH

washer/disinfector
Model PG88XX mit XX ={21, 22, 25, 30} und PG89YY mit YY = {22, 30}

MD: Disinfector

de

fr

Vk_20160711_10
18.07.2016 Synthes GmbH

Adapter for Colibri, for Electric Pen Drive
Model 05.001.024
S/N: all

 

Adaptor, small, for Colibri II and Small Battery Drive II
Model 05.001.108
S/N: all

MD: Surgical power tool adaptor

de

fr

it

en

Vk_20160711_05
18.07.2016 Stryker Instruments

2.3MM Tapered Router
Model 5407-FA2-023
Lot: 15077027, 15077067, 15077097, 15078087, 15105017,15108017, 15108047, 15108077, 15108087, 15108097,15146017, 15146027, 15146037, 15146047

MD: Cranial bur, single-use

de

en

Vk_20160711_09
11.07.2016 Hill-Rom, Inc.

PROGRESSA BED SYSTEM
Model P7500A
S/N: Various serial numbers manufactured between 10-July-2013 to 16-May-2016. The initial affected serial number is O191AW0073 and the final affected serial number is R137AW2538

MD: Mattresses and mattress-coverings for pressure sore prevention

de

fr

it

en

Vk_20160704_04
11.07.2016 Stryker Orthopaedics

Trident Constrained liner Impactor Tips
Model 2199-2022, 2199-2028, 2199-2032
Lot: All lots produced since 2012

MD: Orthopaedic prosthesis implantation instrument, reusable

en

Vk_20160630_16
11.07.2016 ArjoHuntleigh AB

Sara Combilizer
Model APA1000-XX
S/N: P0298176, P0323011, P0361422, P0361423, P0363456

MD: Mobile patient lifting system, battery-powered

de

en

Vk_20160630_15
11.07.2016 Merge Healthcare

CADstream
Software Version: All

MD: MRI system application software

en

Vk_20160630_06
11.07.2016 Vision RT Limited

AlignRT
Software Version: TrueBeam version 2.0/2.5 with any version of AlignRT

MD: Real-time position management respiratory gating system

en

Vk_20160701_09
11.07.2016 Merge Healthcare

CADstream
Software Version: Earlier than 5.2.6

MD: MRI system application software

en

Vk_20160630_04
11.07.2016 Merge Healthcare

OrthoCase
Software Version: 3.7.3 and earlier

MD: Radiology picture archiving and communication system workstation

en

Vk_20160630_03
11.07.2016 Ascensia Diabetes Care Holdings AG

CONTOUR DIABETES App
Software Version: v 1.0.0 &1.0.3 for iOS, v 1.0.0 for android

MD: Data management system, patient

de

fr

it

en

Vk_20160706_02
11.07.2016 Miris AB

Miris Human Milk Analyzer
Model 10-02-001

IVD: Breast milk control

en

Vk_20160614_04
11.07.2016 AB SCIEX Pte. Ltd.

MultiQuant MD Software of API 3200MD LC/MS/MS System, 3200MD QTRAP LC/MS/MS System, Triple Quad 4500MD LC/MS/MS System, QTRAP 4500MD LC/MS/MS System
Software Version: 3.0, 3.0.1, 3.0.2

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

fr

en

Vk_20160701_02
11.07.2016 Bausch & Lomb Inc.

LASEREDGE 1.5mm X 1.7mm Trapezoid Angled Knife
Model E7599
Lot: MAXZ170

MD: Ophthalmic knife, single-use

de

fr

it

en

Vk_20160630_10
11.07.2016 Aptissen SA

HealaFlow
Model A-HEA-060
Lot: 341329 & 341331

MD: Eye drain

de

fr

it

en

Vk_20160630_23
11.07.2016 Medset Medizintechnik GmbH

ECG-Top Amplifier
S/N: 000100B305 - 000295C156

MD: Electrocardiograph, multichannel

en

Vk_20160628_14
11.07.2016 Abbott Laboratories

CELL-DYN Emerald Cleaner
Model 09H46-02
Lot: 7044, 7082, 7110, 7119

IVD: Buffered wash solution IVD, automated/semi-automated system

de

fr

en

Vk_20160628_09
11.07.2016 Varian Medical Systems Inc.

4D Integrated Treatment Console (4DITC) and TrueBeam
Model H19
S/N: All
Software Version: 2.0/2.5

 

EDGE

MD: Linear accelerator system

de

en

Vk_20160708_02
11.07.2016 Synovis Surgical Innovation

Vascu-Guard Peripheral Vascular Patch
Model VG0106N, VG0108N, VG0110N, VG0209N
Lot: see FSN

MD: Cardiovascular patch, animal-derived

de

fr

it

en

Vk_20160707_02
11.07.2016 RaySearch Laboratories AB

RayStation
Model 3.0, 3.5, 4.0, 4.5, 4.7, 5.0
Software Version: 3.0, 3.5, 4.0, 4.5, 4.7, 5.0

MD: Radiation therapy treatment planning system

fr

en

Vk_20160701_06
11.07.2016 Lohmannn & Rauscher GmbH & Co. KG

Update

Metalline Drainage
Model 23093
Lot: 603212208, 606412208

 

Metalline Wound Dressing
Model 23082, 23084
Lot: 550512208

MD: Wound-nonadherent dressing, absorbent

de - 1

de - Update

fr - 1

fr - Update

it - 1

it - Update

Vk_20160613_07
04.07.2016 Siemens Healthcare Diagnostics Inc

Stratus CS Acute Care Diagnostics System
Model 10444834, 10453531, 10453570, 10453571, 10470384

 

Stratus CS 200 Acute Care Diagnostics System
Model 10714016

IVD: Laboratory fluorescent immunoassay analyser IVD, semi-automated

de

fr

en

Vk_20160628_01
04.07.2016 Medtronic Navigation Israel, Ltd.

MRI System
Model 506A0107, 506A0297, 506A0298, 506A0187, 506A0186

MD: Extremity MRI system, permanent magnet

en

Vk_20160624_04
04.07.2016 Synthes GmbH

Guide Sleeve yellow
Model 03.037.017
Lot: See FSN

MD: Surgical drill guide, reusable

de

fr

en

Vk_20160622_04
04.07.2016 ConMed Corp

Core Suction Irrigation Handpieces
Model CD8185, CD8190, CD8200, CD8300, CD8302, CD8400, CD8450
Lot: beginning lot code: 110609Xending lot code 20160308X

MD: Irrigation/aspiration unit

en

Vk_20160624_03
04.07.2016 Synthes GmbH

Prodisc-C vivo, uncemented convex
Model 04.670.955S
Lot: 9736836

MD: Cervical total disc replacement prosthesis, sterile

en

Vk_20160622_02
04.07.2016 Miele and Cie. KG

Olympus ETD 4

MD: Endoscope washer/disinfector

en

Vk_20160622_01
04.07.2016 MicroVention Europe S.A.R.L.

Precipitating Embolic lnjectable Liquid
Model LEN10250, LEN10300, LEN10350
Lot: see FSN

AIMD: Neurovascular embolization implant

fr

en

Vk_20160627_04
04.07.2016 Ivoclar Vivadent AG

Optrapol
Model 634458 / 634459
Lot: VL0704; VL0733; UL0843

MD: Dental abrasive point

de

fr

en

Vk_20160622_07
04.07.2016 Medcomp

PRO-PICC CT BASIC
Model See list
Lot: See list

 

Pro-Line CT
Model See list
Lot: See list

MD: Peripherally-inserted central venous catheter; Central venous catheter

de

fr

it

en

Vk_20160621_12
04.07.2016 Stryker Instruments Kalamazoo

AutoPlex System
Model 0605-887-0000607-687-000
Lot: see FSN

MD: Cement Mixing and Delivery System

de

it

Vk_20160623_02
04.07.2016 Hangzhou Biotest Biotech Ltd

RightSign HIV 1.2.0 Rapid Test Cassette
Model IHIV-C42
Lot: see FSN

 

RightSign HCV Rapid Test Cassette
Model IHCV-C31
Lot: see FSN

 

RightSign HBsAg Rapid Test Cassette
Model IHBSG-C31
Lot: see FSN

IVD: Human immunodeficiency virus multiple antibody kit; Other hepatitis viruses rapid tests; Hepatitis B virus surface antigen rapid test device

en

Vk_20160620_02
04.07.2016 Sorin Group Deutschland GmbH

Heater Cooler Unit 3T
Model 16-02-50, 16-02-80, 16-02-81, 6-02-82, 16-02-85,16-02-95, 16-70-00

MD: Circulating-fluid whole-body heating/cooling system control unit

de

fr

it

en

Vk_20160623_07
04.07.2016 bioMérieux SA

Mueller Hinton Agar with Horse Blood
Model See FSN
Lot: See FSN

IVD: Susceptibility test medium, plate

de

fr

en

Vk_20160615_14
04.07.2016 Medtronic Inc.

DBS Pocket Adaptor
Model 64001, 64002
S/N: All

AIMD: Neural-tissue electrical stimulation lead adaptor

de

fr

en

Vk_20160623_01
04.07.2016 P.P.H.U.ANAD S. LYSZKOWSKI

Masque à Oxygène (concentration 100%) / Sauerstoffmaske (100% O2-Konzentration)
Model 91150023
Lot: 1095 11 ZLM-0115/11

MD: Oxygen Mask

de

fr

Vk_20160701_05
04.07.2016 Becton Dickinson GmbH

BD Columbia III Agar with 5% Sheep Blood
Lot: all

IVD: Isolation medium, plate

de

fr

Vk_20160617_02
04.07.2016 INTEGRA (NEWDEAL)

Achillon System
Model 119700
Lot: all

MD: Wire/ligature passer

de

fr

it

en

Vk_20160623_05
04.07.2016 Roche Diagnostics GmbH

Update

Gentamicin
Model see letter
Lot: see letter

IVD: Gentamicin kit

de - 1

de - 2

fr - 1

fr - 2

en - 1

en - 2

Vk_20160525_05
27.06.2016 Diagramm Halbach GmbH

Disposable Mouthpieces for Spirometers
Model 847521
Lot: 2015/12; 2016/03

MD: Spirometry/pulmonary function pressure tube

de - 1

de - 2

Vk_20160627_05
27.06.2016 GE Medical Systems

Discovery 3.0T MR750
Model 5373011-3, 5396469-3, 5481490-2, 5481500-7, 5499460-7, 5499460-10, 5327625, 5911000-3

MD: Radio-frequency MRI system coil

de

fr

it

Vk_20160617_06
27.06.2016 Qiagen GmbH

QIAsymphony DSP DNA
Model 937236, 937255, 937055
Lot: 154023773 (REF 937236); 154022089 (REF 937255); 154022492 (REF 937255); 154023436 (REF 937055)

IVD: Other Other Genetic Tests

de

fr

it

en

Vk_20160615_03
27.06.2016 Smith & Nephew, Inc.

LEGION HK BOLT AND SLEEVE
Model 71421385, 71421386, 71421388
Lot: 14KTM0007K, 15BTM0007H, 15BTM0007N, 15GTM0013B, 15GTM0013D, 13KTM0014H, 13LTM0008J, 13MTM0010K

MD: Rotating hinged total knee prosthesis

de

fr

en

Vk_20160615_04
27.06.2016 Roche Diagnostics GmbH

Multiplate Analyzer
Model 06675069001

IVD: Laboratory coagulation analyser IVD, semi-automated

de

fr

en

Vk_20160615_02
27.06.2016 Dako Denmark A/S

HER2 CISH pharmDx Kit
Model Code SK109
Lot: 20031665

IVD: DNA-probe, human chromosome

de

fr

Vk_20160620_03
27.06.2016 Sorin Group Italia S.r.l. A Sorin Group Company

D632 Adult Open System bracket
Model 05046
Lot: 0307100085 up to date

 

Adult Oxy module Avant bracket
Model 050128
Lot: 0209230039 up to date

 

Synthesis C- bracket
Model 050350
Lot: 0408310018 up to date

 

D626 Avant Holder
Model 05040
Lot: 9709230010 up to date

 

D630 Avant Holder
Model 05041
Lot: 9911240033 up to date

 

Synthesis Oxygenator Holder
Model 050127
Lot: 0209300020 up to date

 

D625 Lilliput open system bracket
Model 05049
Lot: 9911190012 up to date

 

D623 Lilliput Holder
Model 05061
Lot: 9911160036 up to date

MD: Medical device service rail clamp

de - 1

de - 2

fr - 1

fr - 2

it - 1

it - 2

en - 1

en - 2

Vk_20160620_07
27.06.2016 Siemens Healthcare Diagnostics Inc.

Dimension Vista Creatinine
Model see FSN

 

Dimension Creatinine
Model see FSN

IVD: Creatinine kit

de - 1

de - 2

fr - 1

fr - 2

en - 1

en - 2

Vk_20160616_03
27.06.2016 InnoTERE GmbH

Velox with cannula
Model 020300101
Lot: 170-004-VX

MD: Orthopedic Cement

de

en

Vk_20160617_09
27.06.2016 Drägerwerk AG & Co.KGaA

Babytherm 8004
Lot: all

 

Babytherm 8010
Lot: all

MD: Warmer, radiant, infant, stationary

de

fr

it

Vk_20160617_18
27.06.2016 BioMérieux SA

Mueller Hinton Agar with Horse Blood
Lot: see FSN

IVD: Susceptibility test medium, plate

de

fr

en

Vk_20160615_14
27.06.2016 Medtronic Inc.

Temporary Transvenous Pacing Lead
Model 6416-100, 6416-140, 6416-200
Lot: all

MD: Endocardial pacing lead

de

en

Vk_20160615_15
27.06.2016 Welcare Industries S.p.A

Update

SINAQUA Dermal Glove
Model WEL-95580

MD: Gloves, Other

de - 1

de - 2

fr - 1

fr - 2

Vk_20160629_01