Materiovigilance – Liste Rückrufe

Medizinprodukte – Rückrufe und andere Sicherheitsmassnahmen (FSCA)
Datum Hersteller Handelsname Produktbeschreibung Informationen Referenz Nr. Swissmedic
19.09.2016 Maquet GmbH & Co. KG

Zubehöradapter
Model 600525A0
Lot: Fertigungszeitraum 2002 bis heute

MD: Medical table clamp

de

en

Vk_20160909_06
19.09.2016 Roche Diagnostics GmbH

Combur-Test/Chemstrip/ChoiceLine 10 test
Model see letter
Lot: all

IVD: Urine rapid test device, multiple-constituent

de

fr

it

en

Vk_20160909_03
19.09.2016 Spiegelberg GmbH & Co. KG

Silverline Lumbar Drainage Catheter
Model ELD33.010.02
Lot: 330 0 0157 15

MD: Catheters, Spinal, Intrathecal, Lumbar

de

en

Vk_20160906_06
19.09.2016 B. Braun Melsungen AG

Spinocath
Model 4517717, 4517725
Lot: all

MD: Intrathecal anaesthesia kit

de

fr

it

Vk_20160919_01
19.09.2016 Blackrock Microsystems, LLC

NeuroPort Biopotential Signal Processing System
Model 5703, 5747, 5748, 5749
S/N: all

MD: Monitors, Physiologic, Electroencephalography

de

fr

it

en

Vk_20160909_09
19.09.2016 Radiometer Medical ApS

ABL90 FLEX
Model 393-090

 

ABL90 FLEX PLUS
Model 393-092

IVD: Blood gas/pH/electrolyte/metabolite analyser; Metabolic profile clinical chemistry analyser IVD, portable, automated

de

fr

it

en

Vk_20160907_04
19.09.2016 GE Medical Systems

MAGiC application running on some GEHC MR systems
Model M70012RM
Software Version: MAGiC post process application running on Signa Pioneer AND Discovery MR750, Discovery MR750w, Discovery MR450 & Optima MR450w with DV25.1 software platform

MD: Full-body MRI system, superconducting magnet

de

Vk_20160908_02
19.09.2016 Labortaire Claytone

Terrafor ventre plat
Model 500410
Lot: all

MD: Digestion discomfort control capsule

de

en

Vk_20160909_04
19.09.2016 Völker GmbH

Völker healthcare bed
Model 2080, 2082, S 280 und S 282
Lot: see FSN

MD: Bed, electric

de

fr

it

en

Vk_20160512_06
19.09.2016 Siemens Healthcare Diagnostics Inc

Dimension & Dimension Vista IRON Flex reagent
Model DF85 Dimension Iron K3085 Dimension Vista Iron
Lot: All lots (including all future lots until Instructions For Use is updated)

IVD: Iron IVD, kit, enzyme spectrophotometry

de

fr

en

Vk_20160913_01
13.09.2016 Alere San Diego, Inc

Alere INRatio PT/INR System Professional
Model 0100004

 

INRatio Prothrombin Time PT Monitoring System
Model 0100007

 

Alere INRatio 2 PT/INR Professional Testing Kit
Model 0200431

 

Alere INRatio 2 PT/INR Home Monitoring Kit
Model 0200432, 0200433

 

Alere INRatio PT/INR Test Strips (Self Test & Professional Use)
Model 0100071, 0100139

 

Alere INRatio 2 PT/INR Test Strips_Heparin Insensitive (Self Test & Professional Use)
Model 99007G1, 99007EU, 99008G1, 99008EU

IVD: RT_Coagulation Hardware +accessories + consumables + software

de

fr

it

Vk_20160714_10
13.09.2016 Siemens Healthcare Diagnostics Inc.

Dimension Opiates, Dimension Vista Opiates

 

ADVIA Chemistry Systems Opiate_2 (OP_2)

 

Syva EMIT II Plus Opiate

IVD: Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)

de

fr

en

Vk_20160831_07
13.09.2016 Spacelabs Healthcare

Xhibit Telemetry Receiver
Model 96280
S/N: 6280-000400

 

Xhibit Centeral Station
Model 96102
S/N: SLA0714F00699, SLA0715F01344, SLA0716F02046, SLA1213F00419

MD: Patient monitoring system module, electrocardiographic, telemetric; Patient monitoring system central station monitor

de

fr

it

en

Vk_20160901_01
13.09.2016 ICU Medical Inc.

TEGO Connector
Model D1000; NM1000
Lot: see FSN

MD: Peritoneal Dialysis Catheter Adapters

en

Vk_20160912_01
13.09.2016 bioMérieux SA

Campylosel Agar
Model 43361
Lot: see letter

IVD: Culture medium, non-selective/differential

de

fr

en

Vk_20160831_10
13.09.2016 Biocartis NV

Idylla KRAS Mutation Test
Model A0020
Lot: 2660, 2663, 2707

IVD: KRAS gene mutation IVD, kit, nucleic acid technique (NAT)

de

en

Vk_20160902_04
13.09.2016 Abbott Medical Optics Inc.

Tecnis Symfony
Model ZXR00
S/N: See FSN

 

SENSAR Acrylic Monofocal
Model AR40e
S/N: See FSN

 

Tecnis iTec Preloaded 1-Piece IOL
Model PCB00
S/N: See FSN

 

Tecnis Multifocal 1-Piece
Model ZLB00

 

TECNIS Monofocal 1-Piece
Model ZCB00

MD: Posterior-chamber intraocular lens, pseudophakic

de

fr

Vk_20160831_08
13.09.2016 RaySearch Laboratories AB

RayStation
Model 2.5, 3.0, 3.5, 4.0, 4.3, 4.5, 4.7, 5.0
Software Version: 2.5, 3.0, 3.5, 4.0, 4.3, 4.5, 4.7, 5.0

MD: Radiation therapy treatment planning system

en

Vk_20160902_05
13.09.2016 Stryker Orthopaedics

Cup Positioner / Impactor Handle Assembly
Model 2101-0200
Lot: see FSN

MD: Orthopaedic implant impactor

de

Vk_20160825_06
13.09.2016 AS Laerdal Medical

Laerdal Suction Unit (LSU)
Model LSU w/Serres / LSU w/Reusable / LSU w/ Bemis / LSU w/Abbott; catalogue: 780000xx / 780030xx / 780020xx / 780030xx; Accessory: 780800 LSU NiMH Battery (all lots)
S/N: From 78451361071

MD: Electric emergency suction system

de

fr

it

Vk_20160803_02
05.09.2016 Siemens Medical Solutions USA, Inc.

E.CAM and Symbia E family

MD: Stationary gamma camera system

de

fr

en

Vk_20160823_04
05.09.2016 Hamilton Medical AG

HAMILTON-C3
Model 160005
Software Version: V2.0.0, V2.0.1

MD: Neonatal/adult intensive-care ventilator

de

fr

it

en

Vk_20160823_08
05.09.2016 Siemens Healthcare Diagnostics Inc.

RAPIDPoint 400 Series, RAPIDPoint 500, RAPIDLab 1200 Series Analyzers
Model see FSN
Lot: see FSN

IVD: Point-of-care blood gas/haemoximetry analyser IVD

de

fr

en

Vk_20160825_08
05.09.2016 Sequent Medical Inc.

VIA 27 Microcatheter
Model FG27154-01
Lot: 15102107, 15102701, 15111201, 15112003, 16010403, 16011409, 16031101, 16040801, 16041501, 16042901, 16051201, 16052603, 16061701

MD: Vascular guide catheter, single-use

de

fr

it

en

Vk_20160825_07
05.09.2016 Sorin Group Italia Srl

Perceval Sutureless Aortic Valve
Model PVS21 (ICV1208), PVS23 (ICV1209), PVS25 (ICV1210), PVS27 (ICV1211)

MD: Aortic heart valve bioprosthesis

de

fr

it

en

Vk_20160829_06
05.09.2016 Siemens Healthcare Diagnostics Products GmbH

N Latex ASL
Model OPBU035, OPBU055
Lot: 110749; 110749A; 110749B; 110749C

IVD: Anti-Streptolysin O Reaction Time / Titre (qualitative)

de

fr

en

Vk_20160829_12
05.09.2016 Human Care HC Sweden AB

Human Care Roomer S and Altair
Model 55200-EU/AU/GB/NA/JP, 55210- EU/AU/GB/NA/JP, 55220- EU/AU/GB/NA/JP, 55300- EU/AU/GB/NA/JP
S/N: all

MD: Patient lifting system

de

fr

it

en

Vk_20160829_05
05.09.2016 Flowonix Medical

Prometra Programmable Pump
Model 91827, 91828, 91823
S/N: all unimplanted
Lot: all unimplanted

AIMD: Intrathecal implantable infusion pump, programmable

en

Vk_20160823_06
05.09.2016 Siemens Healthcare Diagnostics Products Limited

IMMULITE / IMMULITE 1000 Rubella IgM
Model see letter
Lot: see letter

 

IMMULITE 2000 / IMMULITE 2000 XPi Rubella IgM
Model see letter
Lot: see letter

IVD: Rubella virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

de

fr

en

Vk_20160826_09
05.09.2016 MAQUET Cardiopulmonary GmbH

Maquet Heater and Maquet Heater/Cooler Systems
Model HU35, HCU20, HCU30, HCU40
Lot: all

MD: Cardiopulmonary bypass system heat exchanger

de

fr

it

en

Vk_20160825_03
30.08.2016 Siemens Healthcare Diagnostics Products GmbH

Update

Dimension Vista Flex reagent cartridge PREALB
Model KT7064 Siemens Material Numbers: 10445906
Lot: 12258MA, 12306MA, 12239MA, 13030MA, 13037MA

IVD: Prealbumin/transthyretin kit

fr - 1

en - 1

en - Update

Vk_20130424_13
30.08.2016 Sage Products Inc.

Comfort Shield Barrier Cream Cloths
Model 7526-X (24-pk), 7453-X (3-pk), 7905-X (8-pk)
Lot: see fsn

MD: Comfort Shield® Barrier Cream Cloths

de

fr

en

Vk_20160824_12
30.08.2016 Codan Argus AG

CODAN ARGUS 718 V
Software Version: all

 

CODAN ARGUS 717 V
Software Version: all

MD: General-purpose infusion pump, line-powered

de

fr

it

en

Vk_20160823_10
30.08.2016 medavis GmbH

DICOM Importer Pro
Software Version: 3.1.1.1

MD: Picture archiving and communication systems (PACS), radiology

de

it

en

Vk_20160822_09
30.08.2016 IMPAC Medical Systems Inc.

Monaco RTP System
Software Version: 3.1 and higher

MD: Radiation therapy application software

de

fr

it

en

Vk_20160817_01
30.08.2016 Biomet Orthopaedics Switzerland GmbH

Optipac 60 Refobacin Bone Cement R
Model 4711500396-1
Lot: A538B08715, A540B08715, A601C09945

MD: Cement, bone

de

fr

en

Vk_20160822_10
30.08.2016 HeartWare, Inc.

HeartWare Ventricular Assist System
Model 1104
S/N: All sterile, un-implanted stock manufactured prior to HW25838

AIMD: Artificial heart, temporary

de

fr

it

Vk_20160816_04
30.08.2016 Newdeal SAS

Large Qwix Positioning screws
Model see fsn
Lot: see fsn

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

de

fr

it

Vk_20160816_03
30.08.2016 Beckman Coulter, Inc.

UniCel DxH 600 Coulter Cellular Analysis System
Model B23858

 

UniCel DxH 800 Coulter Cellular Analysis System
Model 629029, B24465, B24802, B68304

IVD: Haematological cell analyser IVD, automated

de

fr

en

Vk_20160819_01
30.08.2016 Ortho Clinical Diagnostics Inc.

VITROS GLU Slides
Model 1707801
Lot: All

 

VITROS LAC Slides
Model 8433880, 8150112
Lot: All

 

VITROS TRIG Slides
Model 1336544, 8329930
Lot: All

 

VITROS URIC Slides
Model 1943927
Lot: All

IVD: Glucose kit; Lactate IVD, reagent; Triglyceride IVD, reagent; Uric acid IVD, reagent

de

fr

en

Vk_20160817_07
30.08.2016 Waismed Ltd

NIO lntraosseous Device
Model NIO-A, 105000601
Lot: see letter

MD: Intraosseous infusion kit

en

Vk_20160816_05
30.08.2016 Siemens Healthcare Diagnostics Inc.

ADVIA Centaur Systems Calibrator U (Myoglobin)
Model REF 03684480, SMN 10309996
Lot: see letter

IVD: Myoglobin IVD, calibrator

de

en

Vk_20160822_05
30.08.2016 CODAN pvb Critical Care GmbH

Transducer of the DPT-6000er series
Model 74.4039, 74.4272, 74.4357, 74.4522, 74.4523, 74.4549, 74.4608, 74.4609, 74.4612, 74.6174, 74.6188, 74.6680
Lot: 937122, 933478, 936410, 933598, 933600, 936405, 937502, 937060, 936724, 934143, 937061, 937301

MD: Blood pressure transducer, single-use

de

fr

it

en

Vk_20160817_04
30.08.2016 Medtronic CoreValve LLC

Update

ENVEO R DELIVERY SYSTEM
Model ENVEOR-L
Lot: all

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

de

fr

it

en

Vk_20160804_03
30.08.2016 Edwards Lifesciences LLC

Update

Edwards Commander Delivery System
Model 9610TF23, 9610TF26, 9610TF29
Lot: All lot numbers lower than 60380085

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

de - 1

de - Update

fr - 1

fr - Update

it - 1

it - Update

en - 1

en - Update

Vk_20160520_15
30.08.2016 Siemens Healthcare Diagnostics Products GmbH

Update

BEP 2000 System
Model OVMU

 

BEP 2000 Advance System
Model OVMU

IVD: Immunoassay analyser

de - 1

de - Update

fr - 1

fr - Update

en - 1

en - Update

Vk_20150722_01
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

de

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 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