Materiovigilance – list of recalls

Medical devices – List of recalls and other field safety corrective actions (FSCA)
Date Manufacturer Trade name Product description Information Reference number 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