Materiovigilance – Liste Rückrufe

Medizinprodukte – Rückrufe und andere Sicherheitsmassnahmen (FSCA)
Datum Hersteller Handelsname Produktbeschreibung Informationen Referenz Nr. Swissmedic
16.01.2017 Covidien llc

Devon Light Glove
Model 31140208, 31140216, 31140257, 31141784, 571711
Lot: all

MD: Operating/examination/treatment light handle cover, single-use

de

fr

it

Vk_20170106_14
16.01.2017 Immuno-Mycologics, Inc.

Cryptococcal Antigen Lateral Flow Assay (CrAg LFA)
Model CR2003
Lot: 161028142817JH, 161019161504NZ, 161013081750KH, 161003112913JG, 161007110553JG, and 161010145035NZ

IVD: Other Mycology Immunoassays

de

fr

it

en

Vk_20170106_11
16.01.2017 Küschall AG

Manual wheelchairs
Model KSL
S/N: manufactured between 12. October 2016 and 20. December 2016

MD: Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

en

Vk_20170109_07
16.01.2017 Intuitive Surgical, Inc

da Vinci Xi Surgical System
Model IS4000
S/N: SK0078, SK0582, SK0482

MD: Robotic surgical system

en

Vk_20170105_13
16.01.2017 Beckman Coulter, Inc.

UniCel DxH 800 Coulter Cellular Analysis System
S/N: all
Software Version: all

 

UniCel DxH 600 Coulter Cellular Analysis System
S/N: all
Software Version: all

IVD: Haematological cell analyser IVD, automated

de

fr

en

Vk_20170103_11
16.01.2017 Zimmer GmbH

Revitan Revision Stem System
Model see FSN
Lot: All batches

MD: Press-fit hip femur prosthesis, modular

de

fr

it

en

Vk_20170111_03
16.01.2017 Cardiac Pacemaker Inc

EMBLEM S-ICD Programmer
Model 3200
S/N: all
Lot: Starting from July 2013

AIMD: Cardiac pulse generator programmer

de

fr

it

en

Vk_20170110_03
16.01.2017 Siemens Medical Solutions USA, Inc.

Biograph mCT systems, Biograph mCT Flow systems

MD: Stationary gamma camera system

de

fr

it

en

Vk_20170110_02
16.01.2017 IMPAC Medical Systems Inc.

Monaco RTP System
Software Version: 5.10.00, 5.10.01, 5.10.02, 5.11.00, 5.11.01, 5.20.00

MD: Radiation therapy application software

de

fr

it

en

Vk_20170106_09
16.01.2017 Endologix International Holdings B.V.

AFX endovascular AAA system with strata graft material
Model see FSN

 

AFX2 endovascular system with larger diameter sizes (28 mm Main Body and/or 20 mm Iliac Limbs)
Model see FSN

MD: Abdominal aorta endovascular stent-graft

en

Vk_20170106_08
16.01.2017 bioMérieux

various ETEST Systems
Model see FSN
Lot: see FSN

IVD: antimicrobial minimum inhibitory concentration (MIC) IVD

de

fr

en

Vk_20161227_06
16.01.2017 Elekta Instrument AB

Update

Leksell Gamma Knife Perfexion
Model 715000
S/N: FV001 to FV420

MD: Teletherapy radionuclide system

de

de - Update

fr

fr - Update

it

it - Update

en

en - Update

Vk_20141007_07
09.01.2017 HOYA Corporation

Endoskope, diverse

MD: Endoscope

de

fr

it

en

Vk_20170103_07
09.01.2017 Synthes GmbH

Radial Head Prosthesis System
Model see FSN
Lot: see FSN

MD: Elbow radius prosthesis

en

Vk_20161230_07
09.01.2017 Olympus Medical Systems Corp.

URF-V2/URF-V2R flex. Videoureteroscope
Model URF-V2/URF-V2R / N4506330/N4506430

 

URF-P6/URF-P6R URETERO-RENOFIBERSCOPE
Model URF-P6/URF-P6R / N4502030/N4502130

MD: Flexible video ureterorenoscope; Flexible fibreoptic ureteroscope

de

fr

Vk_20161223_07
09.01.2017 Bausch & Lomb Inc.

LASEREDGE 1.6mm X 1.8mm Trapezoid Angled Knife
Model E7600
Lot: MAVR240

MD: Ophthalmic knife, single-use

de

en

Vk_20161228_08
09.01.2017 Bausch & Lomb Inc.

LASEREDGE 1.6mm X 1.8mm Trapezoid Angled Knife
Model E7600
Lot: MAVT070

MD: Ophthalmic knife, single-use

de

en

Vk_20161228_07
09.01.2017 Villa Sistemi Medicali S.p.A.

Apollo / DRF/ EZ / EZ DRF; Clinodigit EVO, Juno DRF
Model See FSN
S/N: See FSN

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

de - 1

de - 2

fr - 1

fr - 2

it - 1

it - 2

en - 1

en - 2

en - 3

Vk_20161228_05
09.01.2017 Maquet

Cardiosave Hybrid/Rescue IABP
Model IABP 0998-xx-0800-xx; Battery 0146-00-0097

MD: Intra-aortic balloon pump

en

Vk_20161228_04
09.01.2017 Siemens Healthcare GmbH; Business Area Advanced Therapies

Update

AXIOM Artis; Artis zee; Artis Q/Q zen
Model see FSN
Software Version: VD11B

MD: Stationary angiographic x-ray system, digital

de - 1

de - 2

fr - 1

fr - 2

en - 1

Vk_20161219_06
09.01.2017 ACUTRONIC Medical Systems AG

Update

Fabian HFO
Model 7200, 7200.i, 7201

 

fabian evolution
Model 7250, 7250.N

MD: Neonatal intensive-care ventilator

en

en - Update

Vk_20161115_02
09.01.2017 Bellco S.r.l.

Update

Formula, Formula Plus, Formula 2000, Formula 2000 Plus, Formula Therapy, Formula Domus
Model all
S/N: all

MD: Haemodialysis system

it

en

en - Update

Vk_20161021_05
03.01.2017 B. Braun Melsungen AG

Certofix Trio
Model 4167408
Lot: 16M30A8551

MD: Central venous catheter

de

en

Vk_20161223_08
03.01.2017 Ortho Clinical Diagnostics Inc.

VITROS Chemistry Products Na+ Slides
Model 8379034

IVD: Sodium (Na+) IVD, reagent

en

Vk_20170103_02
03.01.2017 Roche Diagnostics GmbH

Accu-Chek Connect Diabetes Management App
Model 07250428004
Software Version: V1.2.0, V1.2.2, V2.0.0

MD: Clinical laboratory information system application software

en

Vk_20161221_05
03.01.2017 Roche Diagnostics GmbH

Multiplate Analyzer
Model 06675069001
S/N: All systems with SW 2.04 SN >101513 and all systems with updated SW version to SW 2.04

IVD: Laboratory coagulation analyser IVD, semi-automated

de

en

Vk_20161223_01
03.01.2017 Stanmore Implants Worldwide Limited

METS Modular Tumour System
Model see FSN

MD: Orthopaedic implants

de

fr

it

Vk_20161221_03
03.01.2017 Endologix International Holdings B.V.

AFX EndoVascular AAA System
Model all

MD: Abdominal aorta endovascular stent-graft

de

fr

it

en

Vk_20161220_10
03.01.2017 Trinity Biotech plc

GLUCOSE-6 PHOSPHATE DEHYDROGENASE (G-6-PDH)
Model 345A; 345B
Lot: F117009; F229031

IVD: Other Haematology Reagents

de

fr

en

Vk_20161222_10
03.01.2017 Vygon S.A.

Autoflush
Model 5897.01
Lot: 070515EK, 190515EK, 030615EK, 061115EK, 111215EK, 250116EK, 290316EK

MD: Positive-pressure needleless valve-connector

fr

en

Vk_20161220_09
03.01.2017 Roche Diagnostics GmbH

cobas p 612 pre-analytical system
Model 07563116001
Software Version: 2.0.0, 2.0.1, 2.0.2, 2.0.3

IVD: Specimen processing instrument IVD, automated

en

Vk_20161220_08
03.01.2017 Agfa Healthcare N.V.

NX software
Model 3.0
Software Version: 8950

MD: X-ray system software, application program

de

fr

en

Vk_20161220_07
03.01.2017 Philips Medical Systems Nederland BV

Allura Xper Systems and Allura Integris Systems
Model 72247, 722043, 722001, 722002, 722003, 722005, 722006, 722008
Lot: 989000070011, 989000070122, 989000070123, 989000070124, 989000070125, 989000070126 or 989000070321

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

de

en

Vk_20161223_05
03.01.2017 Nucletron B.V.

Oncentra External Beam
Model 170.730
Software Version: All

MD: Radiation therapy treatment planning system

de

en

Vk_20161221_14
27.12.2016 Philips Medical Systems Nederland BV

CT System Workstation
Model 881005
S/N: see FSN
Software Version: IntelliSpace Portal V.6.5

MD: Food tray, single-use

de

fr

it

en

Vk_20161215_01
27.12.2016 GE Medical Systems SCS,
GE Medical Systems LLC

Prestige VH
Model see FSN
Lot: see FSN

MD: Fluoroscopic x-ray system, general-purpose

de

Vk_20161216_19
27.12.2016 Philips Healthcare

IQon Spectral CT
Model 728332
S/N: see FSN
Software Version: 4.7.0

MD: Full-body CT system

de

fr

it

en

Vk_20161214_10
27.12.2016 NAL VON MINDEN GmbH

NADAL hCG pregnancy rapid test
Model 142002
Lot: All

IVD: HCG - rapid test

fr

it

Vk_20161215_10
27.12.2016 Atrium Medical Corporation

Chest Drainage Atrium Ocean, Oasis, Express, Express Mini
Model See FSN
Lot: All specified product numbers with a lot number less than 244887

MD: Pleural drainage system fluid collector

de

en

Vk_20161215_04
27.12.2016 Medtronic Inc.

Application Card software SynchroMed® II Implantable Drug Pump,
Model 8637-20, 8637-40, 8870
S/N: all
Software Version: BBR and older

AIMD: General-purpose implantable infusion pump, programmable

en

Vk_20161220_02
27.12.2016 Boston Scientific Corporation

IMAGER II Angiographic Catheter,
Model Refer to appendix A
Lot: Refer to appendix A

MD: Angiographic catheter, single-use

de

fr

it

en

Vk_20161219_11
27.12.2016 Synthes GmbH

RIA Tube Assembly
Model 314.746S
Lot: 2251446-I, 2256902-I, 2256903-I, 2256904-I, 2256905-I, 2256906-I, 2256907-I

MD: Surgical irrigation/aspiration tubing set

fr

en

Vk_20161213_10
27.12.2016 Ascensia Diabetes Care Holdings AG

Glucofacts Deluxe
Software Version: v 3.10.07

MD: Data management system, patient

de

fr

it

en

Vk_20161220_01
27.12.2016 In2Bones SAS

NEO Locking screw / NEOVIEW screw set
Model W27 ST112, W27 ST114, W27 ST116, W27 ST120, W27 ST900
Lot: 1510086, 1602064, 1603022, 1606067, 1603023, 1606068, 1512148, 1603026, 1510071, 1510131, 1602134, 1606022

MD: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

fr

Vk_20161216_04
27.12.2016 Aesculap AG & Co. KG

Position Headed Reamer Scaled D8.0mm
Model FO087R
Lot: 52194770

MD: Orthopaedic bur, reusable

de

en

Vk_20161215_13
20.12.2016 Merge Healthcare

eFilm Workstation/eFilm Lite
Software Version: 2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4

MD: Radiology picture archiving and communication system workstation

de

fr

it

en

Vk_20161209_02
20.12.2016 AS Laerdal Medical

Laerdal Compact Suction Unit
Model LCSU4
Lot: siehe FSN

MD: Electric emergency suction system

de

fr

it

Vk_20161207_07
20.12.2016 Orion Diagnostica

QuikRead FOB Sampling Set
Model 138822
Lot: 1665413; 1701971; 1712234; 1725222; 1728480; 1733245

 

QuikRead go iFOBT kit
Model 136189
Lot: JC02; JC91; JD75; JF47

 

QuikRead FOB quantitative kit
Model 138820
Lot: JB10; JB89; JC64; JD20; JD79; JE52

IVD: Faecal occult blood IVD, kit, nephelometry/turbidimetry

de

fr

it

en

Vk_20161207_06
20.12.2016 All Young Medical

I-PRF Tubes
Lot: IP1506-0001, IP0116-0004, IP0416-0005

MD: Tubes, blood collection

de

en

Vk_20161206_08
20.12.2016 Hamamatsu Photonics K. K., Systems Division Joko Factory

NanoZoomer
Model NanoZoomer -XR(L), -SQ, -S210, -S60
S/N: all IVD conform scanner

IVD other: Whole slide imaging

en

Vk_20161207_01
20.12.2016 Medtronic Inc.

Claria MRI, CRT-D SureScan and Amplia MRI CRT-D
Model DTMA2D1, DTMA2D4, DTMA2Q1, DTMA2QQ, DTMB1D4, DTMB1QQ, DTMB2D1, DTMB2D4, DTMB2Q1, DTMB2QQ
S/N: all

AIMD: Polymeric urethral stent, long-term

de

fr

it

en

Vk_20161212_06
20.12.2016 Roche Diagnostics GmbH

PreciControl Varia
Model 05618860190
Lot: 18928501

IVD: Multicomponent clinical chemistry control, assayed, normal

de

en

Vk_20161207_09
20.12.2016 Synthes GmbH

Impactor for PFNA Blade
Model 03.010.410
Lot: all

MD: Orthopaedic implant impactor

de

fr

it

en

Vk_20161212_01
20.12.2016 Siemens Healthcare Diagnostics Products Limited

IMMULITE 2000 / IMMULITE 2000 XPi Intact PTH
Model L2KPP2, L2KPP6 (SMN: 10381441, 10381442)
Lot: 320

IVD: Intact parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

de

fr

en

Vk_20161206_10
20.12.2016 Olerup SSP AB

Olerup SSP HLA typing kits
Lot: Mastermix lot QM9 (with taq) and PR3 (without taq); lot numbers: see letter

IVD: Human leukocyte antigen typing kit

en

Vk_20161209_09
20.12.2016 Sorin Group Deutschland GmbH

Heater-cooler (1T), Heater-cooler 3T, FlexTherm
Model 16-02-50, 16-02-80, 16-02-81, 16-02-82,16-02-83, 16-02-85, 16-02-95, 16-70-00
S/N: All

MD: Cardiopulmonary bypass system heating/cooling unit

de

fr

it

en

Vk_20161201_05
20.12.2016 BrainLAB AG

iPlan RT
Software Version: All

 

iPlan RT Dose
Software Version: All

 

BrainSCAN
Software Version: All

MD: Radiation therapy treatment planning system

de

fr

it

en

Vk_20161212_19
20.12.2016 Intuitive Surgical, Inc

8mm endoscope
Model 470026 ; 470027

MD: Rigid optical laparoscope

de

en

Vk_20161212_10
20.12.2016 Siemens Healthcare Diagnostics Inc

CentraLink Data Management System
Model see letter
Software Version: versions 13.x, v14.x, v15.x

IVD: Clinical data collection/management information system application software

de

en

Vk_20161208_03
20.12.2016 DiaSys Diagnostic System GmbH

oneHbA1c IS
Model 1 3329 _ _ _
Lot: 89, 90

IVD: Glycosylated/Glycated Haemoglobin (IC) CC==>11.02.01.14

en

Vk_20161208_08
20.12.2016 Bausch & Lomb Inc.

Update

LASEREDGE 1.5mm X 1.7mm Trapezoid Angled Knife
Model E7599
Lot: MAKK060, MAXZ170

MD: Ophthalmic knife, single-use

de

de - Update

fr

it

en

en - Update

Vk_20160316_08
20.12.2016 Drägerwerk AG & Co.KGaA

Update

Oxylog 3000 plus
Lot: All devices affected

 

Oxylog 3000
Lot: All devices affected

 

Oxylog 2000 plus
Lot: All devices affected

MD: Transport electric ventilator; Ventilators, Transport

de

de - Update

fr

fr - Update

it

Vk_20151223_11