Materiovigilance – Liste Rückrufe

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

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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

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fr

en

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18.07.2016 bioMérieux

VIDAS Estradiol II
Model 30431
Lot: all

IVD: Oestradiol kit

de

fr

en

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18.07.2016 Roche Diagnostics GmbH

cobas b123 POC System
Model 05122279001; 05122287001

IVD: Blood gas/pH/electrolyte/metabolite analyser

de

fr

it

en

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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

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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

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fr

it

en

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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

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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

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11.07.2016 Merge Healthcare

CADstream
Software Version: All

MD: MRI system application software

en

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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

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11.07.2016 Merge Healthcare

CADstream
Software Version: Earlier than 5.2.6

MD: MRI system application software

en

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11.07.2016 Merge Healthcare

OrthoCase
Software Version: 3.7.3 and earlier

MD: Radiology picture archiving and communication system workstation

en

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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

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fr

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en

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11.07.2016 Miris AB

Miris Human Milk Analyzer
Model 10-02-001

IVD: Breast milk control

en

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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

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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

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11.07.2016 Aptissen SA

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

MD: Eye drain

de

fr

it

en

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11.07.2016 Medset Medizintechnik GmbH

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

MD: Electrocardiograph, multichannel

en

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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

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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

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11.07.2016 Synovis Surgical Innovation

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

MD: Cardiovascular patch, animal-derived

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fr

it

en

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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

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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

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04.07.2016 Synthes GmbH

Guide Sleeve yellow
Model 03.037.017
Lot: See FSN

MD: Surgical drill guide, reusable

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fr

en

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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

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04.07.2016 Synthes GmbH

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

MD: Cervical total disc replacement prosthesis, sterile

en

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04.07.2016 Miele and Cie. KG

Olympus ETD 4

MD: Endoscope washer/disinfector

en

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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

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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

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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

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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

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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

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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

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fr

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04.07.2016 Becton Dickinson GmbH

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

IVD: Isolation medium, plate

de

fr

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04.07.2016 INTEGRA (NEWDEAL)

Achillon System
Model 119700
Lot: all

MD: Wire/ligature passer

de

fr

it

en

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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 Roche Diabetes Care Spain SL

Update

Emminens eConecta
Software Version: v5.4HF12

IVD: Diagnostics & Clinical Interpretation Supporting Software

en

en - Update

Vk_20160617_08
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

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fr

it

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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

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fr

it

en

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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

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fr

en

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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

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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
21.06.2016 Friadent GmbH Dentsply

Implant Pick-Up EV 5.4 Short
Model 25522
Lot: 186641

MD: Dental implant suprastructure, temporary, reusable

de

fr

it

en - 1

en - 2

Vk_20160609_05
21.06.2016 Roche Diagnostics GmbH

cobas b 123 Sensor Cartridge BG/ISE/Glu/Lac
Model 05170478001
S/N: 00200276 - 00200787
Lot: 21560883

IVD: Multiple blood gas/haemoximetry/electrolyte analyte

de

fr

en

Vk_20160608_02
21.06.2016 Synthes GmbH

Mandible Distractor, monoaxial
Model 487.962, 487.963, 487.964, 487.965
Lot: all

 

Proximal Foot Plate
Model 487.974, 487.975
Lot: all

MD: Craniofacial bone distractor

de

fr

en

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21.06.2016 Edwards Lifesciences LLC

EV1000 Clinical Platform System
Model EV1000A
S/N: All

MD: Single-patient physiologic monitoring system

de

fr

en

Vk_20160613_06
21.06.2016 Beckman Coulter, Inc.

Access Free T3
Model A13422
Lot: see FSN

IVD: Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay

de

fr

it

en

Vk_20160606_06
21.06.2016 GE Medical Systems LLC

Discovery 3.0T MR750
Model Discovery 3.0T MR750 used with the 3.0T 6 Channel Flex Coil
Software Version: DV24, DV25 or DV25.1

MD: Radio-frequency MRI system coil

de

fr

it

en

Vk_20160607_06
21.06.2016 Synthes GmbH

Cortex Screw 2.7 mm, self-tapping, length 18 mm, Pure Titanium
Model 402.818
Lot: 9589442

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

de

fr

en

Vk_20160613_04
21.06.2016 Fisher And Paykel Healthcare Ltd

AIRVO2 Humidifier / myAIRVO2 Humidifier
Model PT101 / PT100
Lot: 120521 - 160605

MD: High-flow heated respiratory humidifier

de

fr

en

Vk_20160610_04
21.06.2016 Arkray Factory, Inc.

SPOTCHEM IM SI-3511
Software Version: 2.13

IVD: Semi-automated CC analyser

de

en

Vk_20160609_08
21.06.2016 Stryker Neurovascular

Target Detachable Coil
Model See FSN
Lot: see FSN

MD: Neurovascular embolization coil

de

fr

it

Vk_20160609_01
21.06.2016 Siemens Healthcare Diagnostics Inc.

ADVIA Centaur XPT System
Model SMN 10711433
S/N: All serial numbers manufactured from May 2014 to present
Software Version: V1.01, V1.02, V1.03, V1.1

IVD: Chemiluminescent immunoassay analyser IVD, automated

fr

en

Vk_20160609_10
21.06.2016 Smith & Nephew Medical Ltd.

Allevyn Cavity Wound
Model 66007328
Lot: 1606

MD: Cavity-wound management dressing

de

en

Vk_20160607_07