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
22.08.2016 Bard Medical Division

Bard Hydrogel Coated Prostatic Catheter
Model 1857H20
Lot: MYZAR092

MD: Indwelling urethral drainage catheter

de

en

Vk_20160809_04
22.08.2016 Nutricia Medical Devices BV

Flocare Infinity Enteral feeding pump
Model 35676, 35677, 35679, 35680, 35682, 35683, 35685

MD: Enteral feeding pump

de

Vk_20160810_09
22.08.2016 bioMérieux SA

Mueller Hinton 2 + 5% sheep blood agar (MHS)
Model 43321, 43329, 43324
Lot: All

IVD: General-microorganism antimicrobial susceptibility culture medium IVD

de

fr

en

Vk_20160810_08
22.08.2016 E&L medical systems

Clinic WinData
Software Version: 8.04.52

MD: X-ray film, diagnostic imaging

en

Vk_20160810_06
22.08.2016 ResMed Ltd.

Astral 100

 

Astral 150
S/N: See FSN

MD: Portable ventilator, electric

de - 1

de - 2

fr - 1

fr - 2

it - 1

it - 2

Vk_20160815_09
22.08.2016 Becton, Dickinson and Company

BD Vacutainer® Push Button Blood Collection Set
Model 367342
Lot: 5355533; 5356681

MD: Blood collection/intravenous fluid administration set

de

en

Vk_20160815_05
22.08.2016 Siemens Healthcare Diagnostics Inc.

ADVIA Centaur Systems PSA
Model SMN 10310292 , SMN 10310293
Lot: all

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

de

fr

en

Vk_20160811_04
22.08.2016 LeMaitre Vascular, Inc.

Hydro LeMaitre Valvulotome
Model 1009-00, 1009-00J
Lot: see fsn

MD: Valvulotome

de

fr

it

en

Vk_20160809_08
22.08.2016 Thermo Fisher Scientific Microbiology Basingstoke

Update

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 - 1

en -2

Vk_20160712_14
16.08.2016 Hamilton Medical AG

HAMILTON-MR1
Model 161010
S/N: All serial numbers between 2001 and 2103

MD: Ventilators, transport

de

fr

it

en

Vk_20160805_04
16.08.2016 Sorin Group Italia Srl

PLATINIUM
Model VR 1210, VR 1240, DR 1510, DR 1540, CRT-D 1711, CRT-D 1741, SONR CRT-D 1811, SONR CRT-D 1841

AIMD: Single-chamber implantable defibrillator

en

Vk_20160805_05
16.08.2016 Beckman Coulter, Inc.

UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System
Model 775222
S/N: all

IVD: Specimen processing instrument IVD, automated

de

fr

en

Vk_20160809_01
16.08.2016 Medtronic Physio-Control

LIFEPAK CR Plus
Model 3202359-XXX

 

Lifepak Express
Model 3202177-XXX

MD: Rechargeable public automated external defibrillator; Semi-automated external defibrillator

de

fr

it

Vk_20160803_08
16.08.2016 Siemens Healthcare GmbH

AXIOM Artis; Artis zee; Artis Q/Q zen
Model all
S/N: all

MD: Stationary angiographic x-ray system, digital

de

fr

it

Vk_20160802_12
16.08.2016 Biomerieux

BK Virus R-gene® Real-time Detection and Quantific
Model 69-013B
Lot: 1003909940; 1004754140; 1004764070; 1004927000

IVD: BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

de

fr

en

Vk_20160804_11
16.08.2016 RBC Bioscience Corp

MagCore® Vi ral Nucleic Acid Extraction Kits
Lot: All the lots

IVD: Nucleic acid sample preparation instrument IVD, automated

en

Vk_20160729_01
16.08.2016 Terumo CORPORATION

MISAGO Self-Expanding Stent System
Model Product codes start with SX-V
Lot: all

MD: Multiple peripheral artery stent, bare-metal

de

fr

it

en

Vk_20160804_06
16.08.2016 Spiggle & Theis Medizintechnik GmbH

Inflation Device
Model 2080-9030020
Lot: 15082596

MD: Catheter-balloon inflator, single-use

de

en

Vk_20160804_05
16.08.2016 Medtronic CoreValve LLC

ENVEO R DELIVERY SYSTEM
Model ENVEOR-L
Lot: all

MD: Aortic transcatheter heart valve bioprosthesis, stent-like framework

en

Vk_20160804_03
16.08.2016 Alcon Laboratories Inc.

AcrySof IQ IOL with ULTRASERT Delivery System
Model AU00T0.175, AU00T0.195, AU00T0.220
Lot: 12407022, 12407085, 12407087, 12409013, 12409024, 12409026, 12409028

MD: Posterior-chamber intraocular lens, pseudophakic

de

it

Vk_20160804_02
16.08.2016 Human Care HC Sweden AB

Altair
Model 55200-EU, 55200-GB, 55210-EU, 55210-GB, 55220-EU, 55220-GB
Lot: see FSN

 

Roomer S
Model 55300-EU, 55300-GB
Lot: see FSN

 

HeliQ
Model 55100-EU, 55100-GB, 55110-EU, 55110-GB, 55120-EU, 55120-GB, 55130-EU, 55130-GB, 55140-EU, 55140-GB, 55150-EU, 55150-GB
Lot: see FSN

MD: Stationary patient lifting system, line-powered

fr

en

Vk_20160725_11
16.08.2016 Mölnlycke Health Care AB

Umbilical clamp included in ProcedurePak kits and trays
Model umbilical clamp ref: IFKR21 & 2305123-00

MD: Obstetrical/gynaecological surgical kit, non-medicated, single-use

de

fr

it

en

Vk_20160805_01
16.08.2016 MEDOS Medizintechnik AG

Deltastream HC
Model ME DPHC 0001; ME DPHC 0002
S/N: DP-HC0003 bis DP-HC0296DP-HC1002 bis DP-HC1010DP-NT0001 bis DP-NT0111; TCU0001 bis TCU0007

 

NovaTherm
Model 4000127; 4000122
S/N: DP-HC0003 bis DP-HC0296DP-HC1002 bis DP-HC1010DP-NT0001 bis DP-NT0111; TCU0001 bis TCU0007

 

i-cor console
Model 5000101; 5000100

Cardiopulmonary bypass system heating/cooling unit

de

Vk_20160722_23
16.08.2016 Ergo-Fit GmbH & Co. KG

XRCISE STRESS ECHO
Model V5801-0101, V5801-0102, V5801-0103, V5801-0104
S/N: see FSN

MD: Stress test table

de

en

Vk_20160712_17
16.08.2016 Siemens Healthcare Diagnostics Inc.

Update

Dimension Vista System Flex reagent cartridge BUN
Model K1021
Lot: see FSN

IVD: Blood Urea Nitrogen (BUN) IVD, kit, enzyme spectrophotometry

de

de - Update

fr

fr - Update

en

en - Update

Vk_20160304_01
08.08.2016 Randox Laboratories Ltd

Lipase
Model LI3837 LI7979 LI8050 LI8361

IVD: Lipase Reagent

fr

it

en

Vk_20160726_06
08.08.2016 Siemens Healthcare Diagnostics Inc.

Xprecia Stride Coagulation Analyzer
Model 10714595
Software Version: DMS CD V1.0

IVD: Home-use/point-of-care coagulation analyser IVD, battery-powered

de

fr

en

Vk_20160728_08
08.08.2016 Intuitive Surgical, Inc

IS4000 EndoWrist Stapler 45
Model 470298
Lot: see fsn

 

IS4000 EndoWrist Stapler 30
Model 470430
Lot: see fsn

 

IS4000 EndoWrist Stapler 30 Curved-Tip
Model 470530
Lot: see fsn

MD: Endoscopic motorized cutting stapler

de

fr

en

Vk_20160728_09
08.08.2016 Philips Healthcare

IntelliVue Patient Monitor
Model MX400 866060; MX430 866061; MX450 866062; MX500 866064; MX550 866066
Lot: see FSN

MD: Transportable physiologic monitoring system

de

fr

en

Vk_20160728_05
08.08.2016 Philips Medical Systems Nederland BV

Multidiagnost Eleva, MultiDiagnost Eleva with Flat Detector and UroDiagnost Eleva systems.
Model 708032, 708033, 708034, 708036, 708037, 708038
S/N: several

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

de

fr

it

en

Vk_20160727_09
08.08.2016 N.G.C. Medical srl

Kit for pericardiocentesis and Pericardiocentesis Set
Model LMP003P6-K1 and LMP003P6
Lot: 16-0301316; 16-0301326; 16-0402005; 16-0402006; 16-0502111; 16-0502468; 16-0502468; 16-0502497; 16-0502523; 16-0602587; 16-0602947

MD: Pericardiocentesis catheter

it

en

Vk_20160727_02
08.08.2016 Direct Flow Medical

DFM Transcatheter Aortic Valve System
Model PL 9089
S/N: All

MD: Aortic transcatheter heart valve bioprosthesis, fluid-filled framework

de

fr

it

en

Vk_20160726_04
08.08.2016 Greatbatch Medical

Standard Offset Cup Impactor
Model see FSN

MD: Orthopaedic implant driver

de

fr

it

en

Vk_20160802_05
08.08.2016 The Binding Site Group Ltd

Optilite Analyser
Model IE700

IVD: Laboratory single channel clinical chemistry analyser IVD, automated

de

en

Vk_20160802_03
08.08.2016 Fresenius Kabi AG

HERMANN GASTROSTOMY DRESSING SET
Model 7901081
Lot: 32101266

MD: Procedure Kit/Trays, Dressing

de

Vk_20160726_11
08.08.2016 Boston Scientific Corporation

Lotus Valve System
Model Model: H749LTV230, H749LTV250, H749LTV270; Catalogue: TV23, LTV25, LTV27
Lot: see FSN

MD: Transcatheter heart valve bioprosthesis, stent-like framework

de

fr

it

en

Vk_20160802_07
08.08.2016 Stanmore Implants Worldwide Limited

METS Femoral Plateau Plate
Model mkfp/Std5; mkfp/Std10; mkfp/Std15; mkfp/Std20; mkfp/Sm5; mkfp/Sm10; mkfp/Sm15; mkfp/Sm20
Lot: see FSN

MD: Knee arthroplasty wedge

de

fr

it

en

Vk_20160610_02
02.08.2016 Alere Technologies AS

Alere Afinion CRP
Model 1116060, 1116058 and1116059
Lot: 10182971, 10183049

IVD: C-reactive protein (CRP) IVD, reagent

de

fr

it

Vk_20160722_28
02.08.2016 Mathys AG Bettlach

twinSys double offset adaptor
Model 51.34.0189; 51.34.0190
Lot: 2167229; 2171467; 2173242; 2174186; 2167230; 2171466; 2174187

MD: surgical instrument

de

fr

it

en

Vk_20160720_05
02.08.2016 Maquet GmbH & Co. KG

Befestigungsstück
Model 1002.65A0
Lot: Fertigungszeitraum 2009 bis 2013

MD: Headrest

de - 1

de - 2

fr

it

en

Vk_20160720_03
02.08.2016 Medtronic Navigation Inc.

O-ARM 1000 Imaging System
Model BI-700-00027 and BI-700-00028
S/N: All

 

O-arm O2 Surgical Imaging System
Model BI-700-02000
S/N: all

MD: Portable general-purpose fluoroscopic x-ray system, digital; Radiographic/fluoroscopic unit, general-purpose

de - 1

fr - 1

fr - 2

it - 1

en - 1

en - 2

Vk_20160720_02
02.08.2016 Smith & Nephew, Inc.

WHIPKNOT Soft Tissue Cinch #5 Sutures
Model 7211015
Lot: See Attached

MD: Ligation clip, synthetic polymer, non-bioabsorbable

de

fr

it

en

Vk_20160720_01
02.08.2016 Biomet Inc.

various kits containing ACD-A vials
Model see fsn
Lot: see fsn

MD: plastic tube containing blood anticoagulant acid citrate dextrose A (ACD-A)

de

fr

it

en

Vk_20160722_13
02.08.2016 Novus Scientific AB

TIGR Matrix Surgical Mesh
Model NSTM1015E, NSTM1520E, NSTM2030E

MD: Multi-purpose surgical mesh, synthetic polymer, bioabsorbable

de

fr

it

en

Vk_20160722_01
02.08.2016 bioMérieux SA

Etest Colistin CO 0.016-256
Model 537300-537308
Lot: see FSN

IVD: Colistin minimum inhibitory concentration (MIC) IVD

de

fr

en

Vk_20160725_15
02.08.2016 Siemens Healthcare GmbH

Artis system with 19 inch live display
Model display references DSHC1914-DC with part number 10656055

MD: Stationary angiographic x-ray system, digital

de

fr

Vk_20160725_09
02.08.2016 Fisher & Paykel Healthcare GmbH & Co. KG

AIRVO2 Humidifier / myAIRVO2 Humidifier
Model PT101XX , PT100XX
S/N: 120521YYYYYY bis 160605YYYYYY

MD: High-flow heated respiratory humidifier

de

Vk_20160725_08
02.08.2016 Spacelabs Healthcare

UVSL Command Module
Model 91496
S/N: 1496-140337
Lot: Manifold Lot Codes: 128280, 129420, 129940, or 155640

MD: Power supply, no-break

de

it

en

Vk_20160725_04
02.08.2016 Smith & Nephew Inc.

Sterile RENASYS Transparent Film
Lot: see FSN

MD: Wound dressing kit, sterile

de

fr

it

en

Vk_20160725_07
02.08.2016 Rex Bionics Ltd

REX Rehab
S/N: REX-2013-0063

MD: Ambulation exoskeleton, clinical

fr

en

Vk_20160713_01
02.08.2016 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

fr - 1

fr -2

en - 1

en - 2

Vk_20160418_03
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 DiaSys Deutschland Vertriebs-GmbH

Ganestin
Model 40102, 40103

IVD: Prothrombin time ( Quick Test )

de

fr

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

de

fr

it

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