Materiovigilance – Liste Rückrufe

Medizinprodukte – Rückrufe und andere Sicherheitsmassnahmen (FSCA)
Datum Hersteller Handelsname Produktbeschreibung Informationen Referenz Nr. Swissmedic
18.09.2017 Oculentis B.V.

Lentis
All models starting with L or LS or LU
Lot: All lot numbers falling within the expiration date between 2017-01 and 2020-05

MD: Lenses, Intraocular, Posterior Chamber

de

fr

it

en

Vk_20170911_04
18.09.2017 Unomedical a/s

Medtronic MiniMed Infusion Sets: MiniMed Quick-Set, MiniMed Silhouette, MiniMed Sure-T, MiniMed Mio, MiniMed Mio 30
Model No: see FSN
Lot: Lots manufactured prior to April 2017

 

MD: Electric infusion pump administration set, single-use

en

Vk_20170911_03
18.09.2017 biom'up SA

HEMOSNOW
Model HEM03C
Lot: SPR15006.132122

MD: Collagen haemostatic agent

de

it

en

Vk_20170908_05
18.09.2017 St. Jude Medical

Proclaim Elite Spinal Cord Stimulation (SCS) and Proclaim Dorsal Root Ganglion (DRG) IPG
S/N: All implanted Implantable Pulse Generators (IPGs) within the Proclaim family

 

Infinity Deep Brain Stimulation (DBS) IPG
S/N: All implanted Implantable Pulse Generators (IPGs) within the Infinity family

AIMD: Analgesic spinal cord electrical stimulation system; Deep brain electrical stimulation system

d1- Infinity

d1 - Proclaim

f1- Infinity

f1 - Proclaim

i1- Infinity

i1 - Proclaim

e1- Infinity

e1 - Proclaim

Vk_20170911_01
18.09.2017 SEBIA

Minicap Protein 6
Model 2203
Lot: 05096/02

IVD: Protein electrophoresis IVD, kit, electrophoresis

de

fr

en

Vk_20170908_07
18.09.2017 Waldemar Link GmbH & Co. KG

Impactor Handle
Model 182-131/08
Lot: 1515512, 1514940, 1607606, 1611257

MD: Orthopaedic implant inserter/extractor

de

en

Vk_20170907_02
18.09.2017 Stryker Neurovascular

AXS Offset
Model MM003DC0501500
Lot: 19704728, 19704729, 19704730

MD: Unclassified

en

Vk_20170815_05
18.09.2017 Cristalens Industrie

Artis
Lot: See FSN

 

EAZ
Lot: See FSN

 

LUXIOL
Lot: See FSN

 

NAVIGO
Lot: See FSN

MD: Lens

de

fr

it

en

Vk_20170906_02
18.09.2017 Spiegelberg GmbH & Co. KG

Externes Ventrikeidrainageset
Model EVD30.001.01

 

Externes Ventrikeldrainageset mit Platte und Klemme
Model EVD3O.004.01

MD: Drain

de

fr

it

Vk_20170905_06
18.09.2017 Beckman Coulter, Inc.

Update

Access BR Monitor
Model 387620
Lot: See FSN

IVD: Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)

de

de - Update

fr

fr - Update

it

it - Update

en

Vk_20170410_08
18.09.2017 Medtronic Inc.

Update

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

AIMD: Neural-tissue electrical stimulation lead

de

fr

fr - Update

en

en - Update

Vk_20170317_03
11.09.2017 Carl Zeiss Meditec AG

INTRABEAM PRS 500

MD: Radiotherapy Systems, Orthovoltage

de

fr

Vk_20170830_10
11.09.2017 Zimmer Biomet Inc.

Vanguard Open Box Femoral Component
Model 183100, 183102, 183104, 183106, 183108, 183110, 183112, 183113, 183126, 183128, 183130, 183132, 183133
Lot: See FSN

MD: Uncoated knee femur prosthesis

de

fr

it

en

Vk_20170830_09
11.09.2017 Afikim Electric Vehicles

Powered Scooter
S/N: 1651103 to 1669564

MD: Assistive scooter, electric-motor-driven

en

Vk_20170830_07
11.09.2017 Zimmer Biomet Inc

A.T.S 2200TS and A.T.S 4000TS
S/N: See FSN

MD: Pneumatic tourniquet system

de

fr

it

en

Vk_20170829_09
11.09.2017 Beckman Coulter Ireland, Inc.

AQUIOS CL Cytometer
Model B30166
S/N: All

IVD: Flow cytometry analyser IVD, semi-automated

de

fr

en

Vk_20170831_12
11.09.2017 Aaren Scientific Inc

EC-3 Posterior Chamber Hydrophobic Acrylic Lens
Model EC-3
S/N: See FSN

MD: Lens, intraocular, posterior chamber

de

en

Vk_20170901_03
11.09.2017 Ethicon Endo-Surgery, LLC

Vicryl Rapide
Model see FSN
Lot: see FSN

MD: Polyglactin suture

en

Vk_20170905_01
11.09.2017 Radiometer Medical ApS

AUTOCHECK5+ LEVEL 2
Model 944-075
Lot: R0689

IVD: Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

de

fr

en

Vk_20170904_05
11.09.2017 Intervascular SAS

Intergard Woven
Model IGW0030-15
S/N: 1059747168
Lot: 16A28

MD: Synthetic vascular graft

en

Vk_20170717_13
11.09.2017 Abbott

Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra
Model See FSN
S/N: All serial numbers of the affected devices
Software Version: Merlin Programmer - Model 3330 Version 23.1.2

AIMD: Defibrillator, implantable

de

fr

it

en

Vk_20170829_04
11.09.2017 Applied Medical Resources Corporation

Kii Optical Z-Thread Dual Packs
Model CTR14: 5x55mm; catalogue: 101064401
Lot: 1269694,1275188,1279039,1283226,1287785

MD: Laparoscopic access cannula, single-use

de

en

Vk_20170904_07
11.09.2017 Abbott Molecular Inc; Abbott

Update

Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit
Model 04N66-90
Lot: all

IVD: HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)

de

de - Update

en

en - Update

Vk_20170810_03
04.09.2017 Smiths Medical ASD, Inc.

Sterilwasser, Isotonische Kochsalzlösung und Augenspülung
Model 352, 552, 1065, 1565, R0059, R0159
Lot: see FSN

MD: Inhalation therapy sterile water

de

en

Vk_20170904_03
04.09.2017 Nutricia Medical Devices BV

Flocare Gastrostomy tube (G-tube) ENFit
Model Ch10 (594814), Ch14 (594815), CH16 (594816), Ch18 (594817), Ch20 (594818)

MD: Gastrostomy tube

de

fr

it

Vk_20170822_02
04.09.2017 Sysmex Corporation

FLUOROCELL PLT
Model CD994563
Lot: A6056, A6057, A6058, A6062, A6063, A6066, A6067, A6068, A6074, A6075, A6076, A6084, A6085, A6086, A6089

IVD: CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)

de

fr

en

Vk_20170828_10
04.09.2017 Jarvik Heart Inc

JHI-303 Reserve Battery/Charger
Model JHI-303
S/N: All

 

AIMD: Reserve Battery/Charger for external ventricular circulatory assist system

de

fr

it

en

Vk_20170829_02
04.09.2017 Abbott

Accent, Anthem, Accent MRI, Accent ST, Assurity, Allure, Assurity MRI
Model PM1260, PM1240, PM1272, PM2260, PM2240, PM2272, PM3222, PM3242, PM3262, PM3542, PM3562, PM1210, PM2210, PM3210, PM1222, PM1224, PM1226, PM2216, PM2218, PM2220, PM2222, PM2224,
S/N: All pacemakers within the above model families.
Software Version: Model 3330 Version 23.1.2, Merlin@home v 8.2.2

AIMD: Pacemaker, implantable

de

fr

it

en

Vk_20170829_05
04.09.2017 Remel Europe Ltd.

Thermo Scientific Remel Wellcolex Colour Shigella
Model R30858401
Lot: 1991413, 2130764, 2110576, 2143553, 2143554, 1980287, 2131560

IVD: Multiple Shigella species culture isolate antigen IVD, kit, agglutination

en

Vk_20170828_01
04.09.2017 Spectranetics Corporation

Bridge Occlusion Balloon
Model 590-001
Lot: All

MD: Intravascular occluding catheter, image-guided

de

fr

it

en

Vk_20170825_04
04.09.2017 Sage Products Inc.

Oral care products
Lot: see FSN

MD: Oral care swab, sterile

de

fr

it

en

Vk_20170825_06
04.09.2017 Olympus Winter & Ibe GmbH

Working insert; Bridge
Model A20975A (Working insert, with ramp, one way), A20976A (Bridge, one way), A20977A (Bridge, two way);A20975A, A20976A, A20977A
Lot: See attached list of affected devices.

MD: Rigid cystoscope

de

fr

it

en

Vk_20170825_05
04.09.2017 Horiba ABX

ABX PENTRA HbA1c WB Cal
Model A11A01703
Lot: 1704201 and after

IVD: Multicomponent clinical chemistry calibrator

fr

en

Vk_20170825_14
04.09.2017 Cook Incorporated

Ring Transjugular Intrahepatic Access Set
Model RTPS-100
Lot: 5390640

MD: Soft-tissue biopsy procedure kit, non-medicated

de

fr

en

Vk_20170815_08
04.09.2017 Hitachi High Technologies Corporation (HHT)

Update

cobas 8000
Model 05641446001
Software Version: 05-02, 06-02 and 06-03

IVD: Multi-modality clinical specimen analysis system IVD

de

de - Update

fr

fr - Update

en

en - Update

Vk_20170724_02
04.09.2017 Unomedical Inc

Update

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

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

de

de - Update

fr

fr - Update

it

it - Update

en

en - Update

Vk_20170519_01
04.09.2017 Philips Healthcare

Update

ECG Out Cable
Model M1783A, M5526A

MD: Rechargeable professional automated external defibrillator

de

fr

it

en

Vk_20141209_02
28.08.2017 Maquet Critical Care AB

SERVO-air
Model 6882000
S/N: 10001 -
Software Version: 1.00.03 and earlier

MD: Neonatal/adult intensive-care ventilator

en

Vk_20170821_09
28.08.2017 Stryker Neurovascular

AXS Offset
Model MM003DC0501500
Lot: 19704728, 19704729, 19704730

MD: Unclassified

en

Vk_20170815_05
28.08.2017 Terumo Medical Products

FemoSeal Vascular Closure System
Model C11202
Lot: See ANNEX I of FSN

MD: Femoral artery compression plug, synthetic polymer

de

fr

it

en

Vk_20170816_10
28.08.2017 Mercator MedSystems, Inc.

Bullfrog® Micro-Infusion Device
Model MDL09-0616-145-34;BF101x
Lot: 1680334, 1701945, 1742158, 1705104, 1753030

MD: Coronary artery infusion catheter

de

fr

it

en

Vk_20170818_01
28.08.2017 Permobil AB

Powered Wheelchair
Model C300, C350, C400, C500

MD: Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible

de

fr

it

en

Vk_20170817_11
28.08.2017 Thermofisher Scientific

Streptex Rapid Latex Agglutination Test
Model R30950501
Lot: 1959920, 1987862, 2106328

 

Streptex Extraction Enzyme
Model R30951001
Lot: 1981815, 2105975, 2106329

 

Extraction Enzyme Bottle
Lot: 1960420, 1960621

IVD: Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination

de

fr

en

Vk_20170816_02
28.08.2017 Oculo-Plastik, Inc.

Castrovejo Caliper (20 x 1 mm)
Model 25-140
Lot: 18545

: No CE marking

fr

Vk_20170816_03
28.08.2017 Hamilton Medical AG

Update

HAMILTON-C3
Model 160005

 

HAMILTON-C2
Model 160001

MD: Neonatal/adult intensive-care ventilator

de

de - Update

fr

fr - Update

it

it - Update

en

en - Update

Vk_20170821_07
28.08.2017 Zimmer, Inc.

Persona Tibial Plate Provisionals/Tibial Sizing Plates
Model 42532108301, 42532108302, 42539908301, 42539908302
Lot: 63535352, 63607357, 63613121, 63683139, 63531869, 63576035, 63649575, 63693589, 63531871, 63576041, 63688256

MD: Orthopaedic prosthesis implantation instrument, reusable and Knee tibia trial prosthesis

de

fr

it

en

Vk_20170815_03
28.08.2017 MAQUET Cardiopulmonary GmbH & HMT Medizintechnik GmbH

Update

PLEGIOX Cardioplegia Heat Exchanger
Maquet
Model 70103.4981, 70103.2522, 70103.6144
Lot: All Lot Numbers Manufactured after 2015.07.31 and before 2017.07.31

 

PLEGIOX Cardioplegia Heat Exchanger
HMT
Model H05134, H05175, H06054
Lot: all lots on the market since August 2015

MD: Cardiopulmonary bypass system heat exchanger

de1 - HMT

de1 - Maquet

fr1 - Maquet

fr1 - HMT

it1 - Maquet

en1 - Maquet

Vk_20170802_09
28.08.2017 Hitachi High Technologies Corporation (HHT)

Update

cobas 8000

 

cobas e 601, cobas e 602

 

MODULAR Analytics

 

MODULAR ANALYTICS EVO

 

Cobas 6000 Analyzer

IVD: Chemiluminescent immunoassay analyser IVD, automated; Clinical chemistry analyser, discrete automated; Clinical chemistry analyser

de - 1

de - 2

fr - 1

fr - 2

en - 1

en - 2

Vk_20170626_01
21.08.2017 Arkopharma

ARKOPHARMA Heilerde Plv Btl15 Stk / ARKOPHARMA Argile pdr sach 15 pce
Lot: all

MD: Clay, gastrointestinal dressing

de

fr

Vk_20170807_07
21.08.2017 Heraeus Medical GmbH

PALACOS
Model see FSN

 

COPAL
Model see FSN

MD: Orthopaedic cement, non-medicated

en

Vk_20170809_01
21.08.2017 Covidien llc

Covidien Emprint Percutaneous Antenna with Thermosphere Technology
Model CA15L1, CA20L1, CA30L1, CA15L2, CA20L2, CA30L2
Lot: All

MD: Microwave hyperthermia system applicator, intracorporeal

de

fr

it

en

Vk_20170814_11
21.08.2017 Microline Surgical, Inc.

ReNew Reusable Laparoscopic Instrument Tips
Model 3111, 3121, 3141, 3151, 3161, 3201, 3221, 3231, 3241, 3251, 3261, 3271, 3281, 3291, 3301, 3311, 3321, 3331, 3341, 3351, 3361, 3371, 3381, 3401, 3411, 3421, 3431
Lot: ALL

MD: Laparoscopic Forceps / Laparoscopic Surgical Scissors

de

fr

it

en

Vk_20170810_13
21.08.2017 Fujifilm Corporation

CR
Model IR363AWS
S/N: See FSN
Software Version: V5.0, V5.1, V5.2, V6.0, V6.1, V7.0

 

FDR
Model 1000AWS, 2000AWS, 3000AWS
S/N: See FSN
Software Version: V5.0, V5.1, V5.2, V6.0, V6.1, V7.0

MD: Stationary mammographic x-ray system, digital

de

fr

en

Vk_20170810_14
21.08.2017 Nucletron B.V.

Oncentra Brachy
Model 170.730
Software Version: 4.5, 4.5.1, 4.5.2

MD: Radiation therapy application software

de

fr

it

en

Vk_20170810_12
21.08.2017 Abbott Molecular Inc.

Abbott RealTime HIV-1 Amplification Reagent Kit
Model 02G31-010
Lot: 473470, 474215, 474890, 475025, 475532, 475694, 476172, 476356, 476736, 476951, 476139

IVD: HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)

de

en

Vk_20170809_10
21.08.2017 Zimmer, Inc.

Versys Beaded Hip Stem
Model See FSN
Lot: See FSN

 

Segmental Knee
Model See FSN
Lot: See FSN

MD: Press-fit femoral stem prosthesis; Uncoated knee femur prosthesis

de

fr

it

en

Vk_20170809_09
21.08.2017 BioMérieux Inc.

VITEK 2 Gram-Positive (GP) Identification (ID) Test Kit
Model 21342
Lot: 2420240403, 2420303403

IVD: Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit

de

fr

en

Vk_20170808_04
21.08.2017 Implant Direct Sybron Manufacturing LLC

Spectra-System/Legacy Guided Surgery Handle Kit
Model G-HK
Lot: 65249

MD: Surgical drill guide, reusable

de

Vk_20170728_01
21.08.2017 Siemens Healthcare Diagnostics Inc.

Update

ADVIA Centaur T3
Model SMN 10285733 (80 test kit); SMN 10285732 (400 test kit)
Lot: Kit lots ending in 198

IVD: Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay

en

en - Update

Vk_20170803_06
21.08.2017 Becton, Dickinson & Company

Update

UVE Specimen collection kit
Model 443376

 

BD MAX Vaginal Panel
Model 443710
S/N: NA
Software Version: NA

 

BD MAX CT/GC
Model: 442969

 

BD MAX CT/GC/TV
Model: 442970

IVD: Endocervical/vaginal specimen collection kit, liquid transport medium; Multiple vaginitis-associated organism and Multiple sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

de - 1

de - 2

fr - 2

en - 1

en - 2

Vk_20170721_03