Materiovigilance – Liste Rückrufe

Medizinprodukte – Rückrufe und andere Sicherheitsmassnahmen (FSCA)
Datum Hersteller Handelsname Produktbeschreibung Informationen Referenz Nr. Swissmedic
24.07.2017 Medtronic Inc.

Euphora Rapid Exchange Balloon Dilatation Catheter
Model see FSN
Lot: 212553130 to 213283557

 

Solarice Rapid Exchange Balloon Dilatation Catheter
Model see FSN
Lot: 212553130 to 213283557

Coronary angioplasty balloon catheter, basic

de

fr

it

en

Vk_20170713_04
24.07.2017 Hitachi High Technologies Corporation (HHT)

USM cover 3 of cobas c 501 / c 502
Model 05400937001 (USM) of 04745914001 (C 501) / 05964067001 (c 502)

IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated

de

fr

en

Vk_20170713_03
24.07.2017 Alere Medical Co., Ltd

Alere HIV Combo
Model 7D2846, 7D2847
Lot: Catalog number: 7D284678169K100C, 80671K100C, 81502K100CCatalog Number; 7D284778169K100B, 80671K100A

IVD: HIV1/HIV2 antigen/antibody IVD, kit, immunochromatographic test (ICT), rapid

de

fr

it

Vk_20170717_03
24.07.2017 bioMérieux

Update

Mueller Hinton E Agar (MHE)
Model 413822, 413823, 413824 and 413825
Lot: see fsn

IVD: General-microorganism antimicrobial susceptibility culture medium IVD

de

de - Update

fr

fr - Update

en

Vk_20170713_09
24.07.2017 Qualigen, Inc.

FastPack IP Vitamin D Immunoassay
Model 25000068;25000068
Lot: 1701033-3P, 1701033-4P, 1701033-5P, 1701033-6P

IVD: 25-Hydroxyvitamin D

de

fr

Vk_20170711_06
24.07.2017 Phadia AB

Phadia 1000
Model 12-3800-01

IVD: Fluorescent immunoassay analyser IVD, laboratory, automated

de

en

Vk_20170704_10
24.07.2017 Terumo Medical Corporation

Terumo OPS Valve
Model LH130 and LN130B
Lot: see FSN

MD: Cardiopulmonary bypass system valve, unidirectional flow/pressure control

de

fr

it

Vk_20170718_01
24.07.2017 Zimmer, Inc.

Persona Partial Knee Guide Size 8
Model 42-5781-008-01; 42-5781-008-02
Lot: 63518668; 63518669

MD: Osteotomy guide

de

fr

it

en

Vk_20170714_07
24.07.2017 Otto Bock Mobility Solutions GmbH

Voyager Evo rigid frame wheelchair
Model 480A76=00000_K
S/N: all

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

de

fr

it

Vk_20170714_05
24.07.2017 Etac Supply Center AB

Flex grab rail adhesive mount
Model 81707210, 81707220, 81707230, 81706210, 81707410, 81707420, 81707430, 81706410
Lot: All deliveries up to June 30, 2017

MD: Bath hand rail

en

Vk_20170714_04
24.07.2017 DiaSys Diagnostic System GmbH

Creatinine PAP FS
Model 1 1759...
Lot: 23842, 24197

IVD: Creatinine

en

Vk_20170714_03
24.07.2017 In2Bones SAS

NEO Non-Locking screw / NEOVIEW screw set
Model W27 ST010, W27 ST014, W24 ST014, W27 ST016, W27 ST018, W27 ST900
Lot: all

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

fr

it

en

Vk_20170714_02
24.07.2017 Medtronic Navigation Inc.

Spinous Process Clamp Tall
Model 9734715
Lot: All

 

Spinous Process Clamp Short, Model 9734716
Lot: All

 

Double Spinous Process Clamp Tall
Model 9734723
Lot: All

 

Double Spinous Process Clamp Short
Model 9734724
Lot: All

MD: Multi-purpose stereotactic surgery system

en

Vk_20170712_01
24.07.2017 Siemens Healthcare Diagnostics Inc.

several ADVIA Chemistry Assays; Dimension Assays; Dimension Vista Assays; Syva Assays
Model see FSN

IVD: ADVIA Chemistry, Dimension, Dimension Vista and Syva assays which use NAD(H)/NADP(H) methodology

de

fr

en

Vk_20170713_08
24.07.2017 Pulsar Vascular

Update

PulseRider
Model all
Lot: all

MD: Stents, Vascular

en

de - Update

fr - Update

it - Update

en - Update

Vk_20170703_13
24.07.2017 AIR LIQUIDE MEDICAL SYSTEMS

Update

MONNAL T50
Model KC027500, KC037600, KC039100
S/N: all

MD: Neonatal/adult intensive-care ventilator

de

de - Update

fr

fr - Update

en

en - Update

Vk_20170419_01
18.07.2017 Biomet Orthopedics LLC

DRILL BIT MINI-QUICK CONNECT
Model 231220200, 231220202
Lot: 045785, 046151, 047467, 048461, 048809, 100016, 102325, 045790, 048477, 048811, 100017, 101028, 102338

MD: Fluted surgical drill, single-use, non-sterile

de

fr

it

Vk_20170705_06
18.07.2017 Cosman Medical Inc.

Nitinol TC Reusable Electrodes
Model TCN-5-3M, TCN-10-3M, TCN-15-3M, TCN-5, TCN-10, TCN-15, TCN-20, TCNK-5, TCNK-5-C, TCNK-10, TCNK-10-C, TCNK-15, TCNK-15-C, TCNK-20
Lot: all

MD: Radio-frequency ablation system probe, reusable

de

fr

it

en

Vk_20170707_02
18.07.2017 Thermo Fisher Scientific Microbiology Basingstoke

ThermoScientific Oxoid GC Agar
S/N: CM0367 (B,R,T,Q, K)
Lot: various

IVD: Neiserria species agar culture medium IVD, basic

en

Vk_20170705_03
18.07.2017 Ortho Clinical Diagnostics

Ortho BioVue System Rh/K Cassette
Model 707280
Lot: RHP020F

IVD: Blood grouping/typing sera

de

fr

en

Vk_20170717_10
18.07.2017 Siemens Healthcare GmbH; Business Area Advanced Therapies

Arcadis
Model Varic, Varic gen2, Orbic, Orbic Gen2, Avantic, Avantic Gen2
S/N: Systems with Microsoft Windows operating system

 

Sensis systems

 

syngo X WP
Model X-Leonardo

 

AXIOM Artis systems

 

Artis one

 

Artis Zee

MD: Stationary angiographic x-ray system, digital; Cardiac catheterization laboratory computer; Diagnostic x-ray digital imaging system workstation

en

Vk_20170704_04
18.07.2017 ResMed Ltd.

Astral 100
Model Astral 100, Astral 100SC
S/N: All

 

Astral 150
Model Astral 150
S/N: All

MD: Portable ventilator, electric

de

fr

it

en

Vk_20170704_07
18.07.2017 Siemens Healthcare Diagnostics Inc.

ADVIA Centaur XPT System
Model 10711433
S/N: All serial numbers manufactured from May 2014 to present.

IVD: Chemiluminescent immunoassay analyser IVD, automated

en

Vk_20170210_01
18.07.2017 Joerns Healthcare Ltd

OXFORD DIPPER
Model OP52000

MD: Stationary patient lifting system, power-assisted

en

Vk_20170704_06
18.07.2017 SeraCare Life Sciences

ACCURUN 51 Multi-Marker Hepatits Positive Control
Model A51-5001, A51-5005
Lot: 10164524, 10231486, 10164525, 10231487

IVD: Multiconstituent Controls - Inf.Imm.

fr

en

Vk_20170704_09
18.07.2017 Stanmore Implants Worldwide Limited

JTS Grower Drive Unit
Model MLE 3
S/N: All units

MD: Basic remote control

de

fr

it

en

Vk_20170705_01
18.07.2017 Siemens Healthcare GmbH; Business Area Advanced Therapies

Update

Sensis System
Model all

MD: Cardiac catheterization laboratory computer

de - 1

de - 2

fr - 1

fr - 2

it - 1

it - 2

Vk_20170503_05
10.07.2017 Novo Nordisk A/S

NovoPen Echo
Lot: EVG6823-5; FVG8217-3; EVG4253-5; EVG5699-1; EVG6824-4; FVG8132-C

 

NovoPen 5
Lot: EVG4360-2; FVG7565-4; FVG8659-2; EVG2293-2; EVG2903-2; FVG8656-2

MD: Cartridge-accepting autoinjector, mechanical

de

fr

it

Vk_20170703_07
10.07.2017 Medtronic Navigation Inc.

Straight Suction EM, ENT
Model 9733449
Lot: 17022809, 17030108, 17022207, 17022106, 17020805, 17020904, 17021798, 17020987, 17011896, 17011221, 17011220, 16122237, 16122236, 16121661, 16121260, 16121259, 16112958

 

Curved Suction 70, EM
Model 9733450
Lot: 17030722, 17022421, 17022020, 17020619, 17011918, 17012417, 17010602, 16122724, 16122239, 16122038, 16120563, 16112362

 

Short Curved Suction 90, EM
Model 9733451
Lot: 17030728, 17022027, 17021426, 17013125, 17012724, 17011303, 16122767,16122066, 16112965, 16112164

 

Suction Small AxiEM ENT
Model 9734308
Lot: 17022451, 17011750, 16120349, 16082989, 16081888, 16071987, 16062713, 16060712

MD: Stereotactic surgery system probe, reusable

fr

en

Vk_20170630_16
10.07.2017 Orthofix SRL

POWER DRILL TORQUE LIMITER
Model 99-93568
Lot: All lots of the component code 93568 which is included in the following sale configurations: 99-93568; 99-93506; 99-93509; 99-93790; 99-93791; 99-93792; 99-93793 and 99-93794

MD: External orthopaedic fixation system, single-use, sterile

de

fr

it

Vk_20170628_11
10.07.2017 GETEMED Medizin- und Informationstechnik AG

HL7-WorklistServer / Commander
Model 90812
Software Version: 1.1.x - 1.3.x

MD: Disomy 14 Detection Reagents

de

en

Vk_20170630_10
10.07.2017 Shippert Medical Technologies

Tissu-Trans
Model Tissu-Trans Filtron 100, Tissu-Trans Filtron 500, Tissu-Trans 1000, Tissu-Trans Filtron 2000, Tissu-Trans MEGA 1500, Tissu-Trans Syringe Fill 360
Lot: 12018, 12045, 12076, 12109; 12005, 12019, 12044, 61286, 61421; 11934, 11948, 11984, 12002, 12020, 12046, 61118, 61287, 61363, 61446; 12047, 61235; 11947; 61288, 61464; 12079, 61117, 61143

MD: Liposuction system

fr

en

Vk_20170630_06
10.07.2017 Maquet Critical Care AB

SoKINOX / SERViNO
Model 6694550/6881700
S/N: CH - 77, 79, 316, 419, 420 423

MD: Nitric oxide delivery unit, system-based

en

Vk_20170630_14
10.07.2017 Beckman Coulter, Inc.

COULTER LH 750 Hematology Analyzer
Model 6605632, A85570, A68807
Software Version: all

 

COULTER LH 780 Hematology Analyzer
Model 723585, A90728, A68808
Software Version: all

 

COULTER LH 500 Hematology Analyzer
Model 178832, 178833, 178834, A91062, A90994
Software Version: all

 

COULTER HmX CP Analyzers
Model 6605522, 6605523, 6605524
Software Version: all

 

COULTER HmX AL Analyzers
Model 6605525, 6605526, 6605527, A85566, A85564
Software Version: all

IVD: Haematology analyser; Haematology analyser, cell differential; Haematological cell analyser IVD, automated

de

fr

en

Vk_20170630_02
10.07.2017 CellaVision AB

DI-60
Model CC286297
Software Version: 5.0.x and 6.0.x

IVD: Cell morphology analyser IVD, automated

de

fr

it

en

Vk_20170627_04
10.07.2017 Impac Medical Systems, Inc

MOSAIQ
Model N/A;N/A
Software Version: All Versions

MD: Patient health record information system application software

de

fr

it

en

Vk_20170630_01
10.07.2017 Nova Biomedical

Stat Profile Prime
Model see letter
Software Version: all

IVD: Blood gas analyser IVD, point-of-care

en

Vk_20170627_09
10.07.2017 Hologic, Inc.

Tomcat Instrument
Model ASY-07379, RASY-07379

IVD: Microplate robotic transfer IVD, automated

de

fr

it

en

Vk_20170627_01
10.07.2017 OptiMed Medizinische Instrumente GMBH

Percutaneous Introducer Sheath
Model 1221-2410 and 1221-2510
Lot: see FSN

MD: Catheter introducer

de

en

Vk_20170630_13
10.07.2017 TORNIER SAS

Aequalis Ascend Flex Shoulder System
Model DWF601B, DWF602B, DWF602C, DWF603A, DWF603B, DWF604A, DWF604B, DWF604C, DWF605B, DWF605C, DWF611B, DWF613C, DWF616C

MD: Total reverse shoulder prosthesis

de

fr

it

Vk_20170703_01
10.07.2017 Horiba ABX

YumizenH500 CT
Software Version: 2.1.0 and lower

IVD: Haematology analyser, cell differential

de

fr

en

Vk_20170629_09
10.07.2017 Cyberonics, Inc.

AspireSR Generator
Model 106

 

AspireHC Generator
Model 105

AIMD: Antiseizure/psychiatric-therapy vagus nerve electrical stimulation system

de

fr

en

Vk_20170629_01
10.07.2017 Shenzhen Mindray Bio-medical Electronics Co.,Ltd

WATO Anesthesia Machine

 

A-Series Anesthesia Machine

MD: Anaesthesia unit, mobile

de

fr

it

Vk_20170704_03
10.07.2017 Siemens Healthcare GmbH

Artis Systems

MD: Cardiac catheterization laboratory computer

de

fr

it

Vk_20170626_05
03.07.2017 Datascope Corp.

Datascope Intra-Aortic Balloon Pump
Model CS100, CS100i and CS300 IABP
S/N: All serial numbers distributed March 24, 2003 through December 11, 2013

MD: Intra-aortic balloon pump

de

fr

it

en

Vk_20170620_08
03.07.2017 Boston Scientific CRM

Emblem S-ICDs
Model A209, A219
S/N: all

 

Emblem MRI S-ICDs
S/N: all

 

SQ-RX S-ICD
Model 1010
S/N: all

AIMD: Single-chamber implantable defibrillator

de

fr

it

en

Vk_20170620_03
03.07.2017 bioMérieux

BK Virus R-gene Real-time Detection and Quantification Kit
Model 69-013B
Lot: 1004754140, 1004764070, 1004927000, 1004965280

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

de

fr

en

Vk_20170620_02
03.07.2017 GE Healthcare Integrated IT Solutions

Centricity High Acuity Critical Care
Software Version: Versions 7.0 Service Pack 2D to 9.0

MD: Patient health record information system

de

fr

it

en

Vk_20170626_03
03.07.2017 Hitachi High Technologies Corporation (HHT)

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

fr

en

Vk_20170626_01
03.07.2017 Hitachi High Technologies Corporation (HHT)

cobas e 411
Model disk system: Model No. 04775279001
rack system: Model No. 04775201001

 

Elecsys 2010 analyzer
Model disk system: Model No. 11568248001
rack system: Model No. 11804014001

IVD: Chemiluminescent immunoassay analyser (CLIA); Immunoassay analyser

de

fr

en

Vk_20170623_06
03.07.2017 Siemens Healthcare Diagnostics Inc.

ADVIA Centaur Calibrator 30
Model SMN 10379810 (2PK); 10379811 (6PK); 10697756 (Ref 2PK)
Lot: see letter

IVD: Multiple steroid hormone IVD, calibrator

de

fr

en

Vk_20170621_07
03.07.2017 Qiagen GmbH

QIAamp DSP Virus Kit
Model 60704
Lot: 154025928, 154027751, 154029053, 154029743, 154029744

IVD: Other Other Genetic Tests

de

fr

it

en

Vk_20170623_07
03.07.2017 Balt Extrusion

SONIC Microcatheter
Lot: All

MD: Intravascular microflow catheter

de

fr

en

Vk_20170622_04
03.07.2017 William Cook Europe ApS

Zenith Alpha Thoracic Endovascular Graft
Model See attached list
Lot: All lot numbers

MD: Synthetic vascular graft

de

fr

it

en

Vk_20170626_04
03.07.2017 Sarstedt AG & Co.

CTAD-Monovette
Model 04.1909.001
Lot: 6384911, 7287611

IVD: Tubes with other anticoagulants

de

en

Vk_20170627_06
03.07.2017 Gambro Lundia AB

Update
(betrifft nur Sofware Version 6.10)

Prismaflex System, Prismaflex 4.11, Prismaflex 5.0
Model 107493, 113082, 113874, 114489, 114870, 955052, 6023014700
S/N: All
Software Version: 4.11, 5.00, 6.10, 7.XX, 8.XX

MD: Haemodialysis system, institutional

de

fr

fr - Update

en

en - Update

Vk_20170307_06
03.07.2017 Cardiac Pacemaker Inc

Update

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

AIMD: Cardiac pulse generator programmer

de - A

de - B

de - Update C

fr - A

fr - B

fr - Update C

it - A

it - B

it - Update C

en - A

en - Update C

Vk_20170110_03
26.06.2017 Zimmer, Inc.

Guide wire 70 cm
Model 00-2255-025-00, 00-2255-026-00, 47-2255-008-00, 47-2490-098-00, 47-2490-098-01
Lot: See FSN

MD: Orthopaedic prosthesis implantation instrument, reusable

de

fr

it

en

Vk_20170619_08
26.06.2017 Medical Intelligence Medizintechnik GmbH

HexaPOD evo RT System
Model P10603-109, P10603-110
Software Version: iGUIDE versions 2.2.0, 2.2.1

MD: Table, radiotherapy

de

fr

it

en

Vk_20170619_07
26.06.2017 Hitachi Ltd.

HITACHI ARIETTA Prologue
Model ARIETTA Prologue
Software Version: Ver.1.1, Ver.1.2, Ver.1.3.0

MD: Scanner, ultrasonic, general-purpose

de

fr

it

en

Vk_20170613_04
26.06.2017 Endologix International Holdings B.V.

AFX endovascular AAA system with strata graft material
Model All models containing Strata graft material - see list in FSN attached;N/A

MD: Abdominal aorta endovascular stent-graft

de

fr

it

en

Vk_20170619_03
26.06.2017 Boston Scientific Corporation

Encore 26 Inflation Device
Model H74904526011, M001151050, M00566670, M0067101140
Lot: Refer to Attachment 1

MD: Catheter-balloon inflator, single-use

de

fr

it

en

Vk_20170619_04
26.06.2017 Baxter Healthcare SA

Sharesource Connectivity Platform for use with Homechoice Claria APD System
Model 5CGM01

MD: Nephrology information system application software

de

fr

it

en

Vk_20170615_14
26.06.2017 Cook Incorporated

Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System
Model N/A;FVO-150, FV-090075-150, FV-090045-150
Lot: All lots

MD: Flexible ureteral sheath/fibreoptic telescope

de

fr

en

Vk_20170613_02
26.06.2017 Baxter

PrisMax Hemodialysis Machine
Model 115369
S/N: 100078, 100055, 100057, 100059, 100069, 100070, 100071, 100072, 100073, 100074, 100080, 100083, 100087, 100088, 100089

MD: Haemodialysis system, institutional

en

Vk_20170615_12
26.06.2017 Acandis GmbH & Co. KG

NeuroSpeed PTA Balloon Catheter
Model 01-000601
Lot: 139914

MD: Embolectomy/thrombectomy catheter

de

en

Vk_20170615_06
26.06.2017 Natus Neurological Incorporated

Nicolet Elite Probe
Model X1L001, X1L004, X1L007, X1L008, N200, NW20, N300, N500

MD: Ultrasonic, Doppler

en

Vk_20170615_01
26.06.2017 Philips Healthcare (Suzhou) Co.Ltd

DuraDiagnost
Model 712210, 712211
S/N: see UAL
Lot: NA
Software Version: NA

MD: Stationary basic diagnostic x-ray system, digital

de

en

Vk_20170613_06
26.06.2017 AngioDynamics, Inc.

Acculis Accu2i pMTA Applicator
Model 900-600, 900-601 & 900-602
Lot: Various - see attachment

MD: Microwave hyperthermia system applicator, intracorporeal

de

fr

it

Vk_20170613_05
26.06.2017 Biomet Orthopedics LLC

Update

Comprehensive Nano Humeral Component PPS
Model 115730, 115732, 115734, 115736, 115738, 115740
Lot: All

MD: Coated shoulder humeral stem prosthesis

de - Update

fr- Update

it - Update

en

en - Update

Vk_20170607_07