Materiovigilance – Liste Rückrufe

Medizinprodukte – Rückrufe und andere Sicherheitsmassnahmen (FSCA)
Datum Hersteller Handelsname Produktbeschreibung Informationen Referenz Nr. Swissmedic
18.04.2017 Autonomic Technologies Inc. (ATI)

Pulsante SPG Microstimulator System
Model NS-100, RC-200, SI-100-E, SI-110-E, SI-120-E, LB-100-E, PS-100
Lot: All lots manufactured after November, 2010
Software Version: 0.5.9.0

AIMD: Neurosurgical procedure kit, non-medicated, single-use

de

en

Vk_20170410_02
18.04.2017 Siemens Healthcare Diagnostics Inc.

RapidPoint 500
Model 10697306
S/N: 40412, 40457, 40458, 40459, 40460, 40461, 40463, 40466, 40467, 40468, 40469, 40470, 40471, 40472, 40508, 40509, 40510, 40512, 40561, 40562, 40565, 40594, 40596, 40649, 40650, 40651, 40652, 40656
Software Version: V2.4B

IVD: Blood gas/pH/electrolyte/metabolite analyser

fr

Vk_20170405_05
18.04.2017 Natus Medical Incorporated

neoBLUE LED Phototherapy System
Model 010066, 010068, 010069, 010070
S/N: 2. generation neoBLUE LED Phototherapy Systems sold from 2003 to 2008
Lot: 10500 to 17919

MD: Overhead infant phototherapy unit

de

fr

en

Vk_20170405_03
18.04.2017 Newport Medical Instruments, Inc.

Newport HT70 Ventilators
Model see FSN

MD: Neonatal/adult intensive-care ventilator

en

Vk_20170406_02
18.04.2017 Olympus Medical Systems Corp.

Flexible Video Duodenoscope
Model N4497430

MD: Flexible video duodenoscope

en

Vk_20170410_03
18.04.2017 bioMérieux SA

Etest ERTAPENEM ETP 32
Model 531640, 531600
Lot: see FSN

IVD: Ertapenem minimum inhibitory concentration (MIC) IVD

de

fr

en

Vk_20170406_01
18.04.2017 Perouse Medical (Ivry Le Temple Plant)

Dolphin Inflation device / Caliber Inflation Device
Model 0185NA ; 0185ND ; 0185NR ; 0185PD ; 0185QL ; 0185TD ; 0185TS ; CL3030 (Caliber)
Lot: All batches numbers (8 digits) beginning by: 1504XXXX to 1512XXXX, 1601XXXX to 1612XXXX

MD: Catheter-balloon inflator, single-use

fr

en

Vk_20170406_05
18.04.2017 Arrow International Inc

ARROW Kits with BD Eclipse Needles
Model see FSN
Lot: see FSN

MD: Central Venous Catheter; Haemodialysis Catheter, Non-implantable; Peripheral vascular infusion/aspiration catheter; Peripherally-inserted central venous catheter; Vascular catheter introduction kit; Vascular catheterization support kit

en

Vk_20170410_10
18.04.2017 Sorin Group Italia Srl

Paradym

 

Intensia

 

Ovatio

AIMD: Dual-chamber implantable defibrillator; Cardiac resynchronization therapy implantable defibrillator; Single-chamber implantable defibrillator

de

fr

it

en

Vk_20170410_07
18.04.2017 St. Jude Medical CRMD

Merlin@Home Transmitter
Model EX1150, EX1150W, EX1100, EX1100W
S/N: All
Software Version: 8.2.2

AIMD: Transtelephonic implantable pacemaker analysis system

de

fr

it

en

Vk_20170404_01
18.04.2017 Ortho Clinical Diagnostics Inc.

Update

VITROS Chemistry Products Na+ Slides
Model 8379034

IVD: Sodium (Na+) IVD, reagent

de - 1

de - 2

fr - 1

fr - 2

en - 1

en - 2

Vk_20170103_02
18.04.2017 Stryker Orthopaedics

Update

LFIT Anatomic CoCr V40 Femoral Heads
Model see FSN
Lot: lots manufactured since 01 January 2002 to 04 March 2011

MD: Metallic femoral head prosthesis

de

de - Update

fr

fr - Update

it

it - Update

Vk_20160928_01
10.04.2017 Cepheid AB

Xpert CT/NG
Model GXCT/NG-CE-10, GCXCT-CE-10
Lot: 1000043096, 1000044234, 1000043097

IVD: Multiple sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

de

en

Vk_20170403_09
10.04.2017 Nexstim Plc

Nexstim NBS System
Model 4, 5
S/N: All serial numbers starting from 10271241N4 (manufactured in July 2010) until today
Software Version: 4.0 or higher, 5.0 or higher

MD: Stereotactic neuronavigation/planning system

de - 1

de - 2

Vk_20170403_08
10.04.2017 Philips Medical Systems Nederland BV

Allura Xper Systems, CV2O Systems and UNIQ systems
Model see letter

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

de

fr

it

en

Vk_20170331_04
10.04.2017 Mizuho OSI

Wilson Frame Pads
Model 5319-37 / GTIN: 00842430100192
Lot: Mfr dates 2016-12-01 through 2017-03-20

MD: Operating table mattress

de

fr

it

en

Vk_20170331_02
10.04.2017 Abbott - Thoratec Corporation

HeartMate II LVAS System Controller
Model 105109, catalogue: 106016 and 106017
S/N: all
Software Version: 7.29

AIMD: Implantable ventricular circulatory assist system control unit

de

fr

it

en

Vk_20170330_06
10.04.2017 Biomet France SARL

Vanguard ROCC; Vanguard Alpina; Alpina APS; Alpina APR; Alpina Uni; Exception stem; Avantage cup
Model see fsn
Lot: see fsn

MD: various prostheses & components

de

en

Vk_20170330_04
10.04.2017 Soluscope SAS

SOLUSCOPE endoscope washer-disinfector
Model Soluscope Serie 3 GTA, catalogue: 5076
S/N: 23352
Software Version: 1.31

MD: Flexible endoscope washer

fr

Vk_20170330_01
10.04.2017 Aesculap AG & Co. KG

Diamond Burr, single-use
Model see FSN
Lot: all

 

Diamond Burr, reusable
Model see FSN
Lot: all

MD: Orthopaedic bur, single-use



MD: Orthopaedic bur, reusable

de

en

Vk_20170329_07
10.04.2017 bioMérieux SA

ETEST OX 256 (OXACILLIN)
Model 520558, 520518
Lot: see letter

IVD: Oxacillin minimum inhibitory concentration (MIC) IVD

de

fr

en

Vk_20170329_05
10.04.2017 GE Vingmed Ultrasound AS

Vivid
Model E80, E90, E95, S60N, S70N, S60, S70
Software Version: 201.54, 201.55, 201.61, 201.63

MD: Cardiovascular ultrasound imaging system

de

fr

it

en

Vk_20170329_06
10.04.2017 Abbott Vascular Inc.

ABSORB Bioresorbable Vascular Scaffold System
Model 1012462-08, 1012462-12, 1012462-18, 1012462-23, 1012462-28, 1012463-08, 1012463-12, 1012463-18, 1012463-23, 1012463-28, 1012464-12, 1012464-18, 1012464-23, 1012464-28
Lot: all

 

ABSORB GT1 Bioresorbable Vascular Scaffold System
Model 1234250-08, 1234250-12, 1234250-18, 1234250-23, 1234250-28, 1234300-08-1234300-12, 1234300-18, 1234300-23,1234300-28, 1234350-12, 1234350-18, 1234350-23, 1234350-28
Lot: all

MD: Drug-eluting coronary artery stent, fully-bioabsorbable

de

fr

it

en

Vk_20170329_03
10.04.2017 Beckman Coulter, Inc.

Access 2 Immunoassay System
Model see FSN
S/N: see FSN

 

UniCel DxC 600i System
Model see FSN
S/N: see FSN

IVD: Chemiluminescent immunoassay analyser IVD, automated; Laboratory multichannel clinical chemistry analyser IVD, automated

de

Vk_20170307_05
10.04.2017 SEJONG MEDICAL CO., LTD.

Laport-L
Model N53-0510
Lot: 2016.07.08

MD: Laparoscopic sleeve

de

Vk_20170330_05
10.04.2017 CareFusion Switzerland 317 Sàrl

Alaris syringe driver
Model see fsn
Lot: all

MD: Syringe pump

de

fr

it

en

Vk_20170228_06
03.04.2017 William Cook Europe ApS

Zenith Alpha Thoracic Endovascular Graft
Model See FSN

MD: Synthetic vascular graft

en

Vk_20170322_05
03.04.2017 MEDTECH

ROSA
Model Brain 3.0.0, One 3.1.0, Spine 1.0.2
S/N: BR15003, BR15002, BR16027, BR16019, BR16020, BR16026, BS16001, SP16008, BR16005, BR16004, BR16006, BR16012, BR16011, BR16009, BR16010, BR16014, BR16013, BR16015, BR16021, BR16017, BR16018, BR16016, BR16023, BR16025

MD: Neurological stereotactic surgery system

fr

en

Vk_20170322_01
03.04.2017 Zimmer Biomet

Femoral IM Nail
Model see fsn
Lot: Lot Number Expiry Date Before March 2027

 

Segmental Stem; Porous stem
Model see fsn
Lot: see fsn

MD: Femur nail, sterile; Knee stem

de

fr

it

en

Vk_20170321_03
03.04.2017 Cook Incorporated

Bush DL/SL Ureteral Illuminating Catheter Set
Lot: See FSN

MD: Fibreoptic ureteral catheter, single-use

de

Vk_20170327_04
03.04.2017 Philips Medical Systems (Cleveland) Inc

BrightView

 

BrightView XCT Imaging System

 

BrightView X

MD: Stationary gamma camera system; PET/CT system

de

fr

en

Vk_20170324_04
03.04.2017 Draeger Medical Systems, Inc.

Delta XL
Model MS18596
Software Version: VF10.0

 

Kappa
Model MS18853
Software Version: VF10.0

 

Delta
Model MS18597
Software Version: VF10.0

MD: Patient monitoring system; Monitoring Systems, Physiologic

de

Vk_20170327_01
03.04.2017 Biomet UK Ltd

Oxford Unicompartmental Cementless Tibial Trays
Model see FSN
Lot: all

MD: Unicondylar knee prosthesis

de

fr

it

en

Vk_20170323_04
03.04.2017 Bracco Injeneering S.A.

CT Exprès Contrast Injection System, Model Temperature Maintainer
Model; 650207, 650208
S/N: T0030016-0516 to T0030299-0117

MD: CT contrast medium injection system, line-powered, mobile

de

fr

it

en

Vk_20170328_01
03.04.2017 Philips Healthcare

MX40
Model 865352

MD: Single-patient physiologic monitoring system

de

en

Vk_20170327_15
03.04.2017 Schaerer Medical AG

schaerer arcus
Model arcus 501/601/701
S/N: AR-4828; AR-4839; AR-4841; AR-4846; AR-4847; AR-4848; AR-4854

MD: Universal operating table, electrohydraulic

de

fr

en

Vk_20170327_09
03.04.2017 SMEDICO AG

SAMA Steril Set
Model SIS2077-10, SIS2095-08, SIS2096-08, SIS2097-06, SIS2097-07, SIS2303-02

MD: General surgical procedure kit, non-medicated, single-use

de

Vk_20170315_08
03.04.2017 Medtronic MiniMed

Medtronic MiniMed 640G Insulin Pump
Model MMT-1711, MMT-1712
S/N: all with software version 2.6
Software Version: 2.6

MD: Ambulatory insulin infusion pump

de

fr

it

en

Vk_20170201_01
27.03.2017 Nobel Biocare AB

Multi-unit abutment Plus CC RP 2.5mm
Model 38882
Lot: 12076345

MD: Dental implant suprastructure, temporary, reusable

en

Vk_20170320_14
27.03.2017 Stryker Instruments

SmartLife Large Aseptic Housing
Model 7126-120-000
Lot: Not lot number related

MD: Rechargeable battery pack

en

Vk_20170320_02
27.03.2017 Medtronic Inc.

Deep Brain Stimulation (DBS) Lead Kits
Model 3387, 3389, 3391
Lot: All

AIMD: Neural-tissue electrical stimulation lead

de

fr

en

Vk_20170317_03
27.03.2017 Siemens Healthcare Diagnostics Inc

Ammonia Flex reagent cartridge
Model SMN 10711991, P/N DF119
Lot: all

IVD: Ammonia IVD, kit, enzyme spectrophotometry

de

fr

en

Vk_20170317_02
27.03.2017 ArcRoyal Ltd

ArcRoyal Custom Procedure Trays containing BD Plastipak 100 ml Syringe 10-005358
Model 10-005358

MD: General surgical procedure kit, non-medicated, single-use

de

fr

en

Vk_20170320_11
27.03.2017 Tem Innovations GmbH

r ex-tem
Model 503-05
Lot: 21734044

IVD: Unclassifiable and Other Haemostasis Reagents

de

Vk_20170317_08
27.03.2017 Abbott Vascular Inc.

NC Trek RX Coronary Dilatation Catheter
Model See FSN
Lot: See FSN

MD: Coronary angioplasty balloon catheter, basic

de

fr

it

en

Vk_20170320_17
27.03.2017 Siemens Healthcare Diagnostics Inc

Dimension Vista 500 Intelligent Lab System, Dimension Vista 1500 Intelligent Lab System
Model Dimension Vista 500: SMN10488224; Dimension Vista 1500: SMN 10444802
Software Version: v3.6.2 SP1, v3.7

IVD: Laboratory multichannel clinical chemistry analyser IVD, automated

de

fr

en

Vk_20170316_09
27.03.2017 Salvia medical GmbH & Co. KG

elisa
Model 600, 800, 800 VIT
Software Version: 1.07.0, 1.07.1, 1.07.2, 1.07.3, 1.07.4

MD: Intensive care ventilator

de

en

Vk_20170316_08
27.03.2017 Roho, Inc., a subsidiary of The Roho Group, Inc.

ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology
Model See FSN
S/N: Serial numbers falling between A2920163 and A3185287

 

ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology
Model see FSN
S/N: Serial numbers falling between A2920163 and A3185287

MD: Wheelchair cushion

de

fr

it

en

Vk_20170315_11
27.03.2017 Philips Healthcare

HeartStart MRx Defibrillator/ Monitor
Model M3535A (M3535ATZ), M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9

MD: Defibrillator/monitor

de

fr

it

en

Vk_20170314_06
27.03.2017 Intuitive Surgical, Inc

EndoWrist Stapler Release Kit
Model 381215-02 ; 381384-01 ; 381389-01 ; 381395-01; 381381-01 ; 381385-01 ; 381390-01 ; 381401-01; 381382-01 ; 381386-01 ; 381391-01 ; 381402-01; 381383-01 ; 381387-01 ; 381393-01 ; 381403-01

MD: Surgical torque wrench

de

fr

en

Vk_20170307_10
27.03.2017 Siemens Healthcare GmbH

Artis system with wireless foot switch
Model 4787797, 4787805, 4787813

MD: Stationary angiographic x-ray system, digital

de

fr

it

en

Vk_20170320_06
27.03.2017 Paul Hartmann AG

Update

CombiSets containing Becton Dickinson 100ml Plastipak Catheter Tip syringe
Model 2482691, 2482692, 2482693, 2484631, 2484632, 2485611, 2488801, 2626192, 2626193, 2642021, 2668565, 2642021, 2668566
Lot: see FSN

MD: General surgical procedure kit, non-medicated, single-use

de

de - Update

en

Vk_20170220_12
20.03.2017 1stQ GmbH

AddOn
Model A4SW00

MD: Anterior-chamber intraocular lens, pseudophakic

de

fr

en

Vk_20170309_02
20.03.2017 Covidien llc

Curity Sodium Chloride Dressing
Model 3339
Lot: see FSN

 

Curity Eye Pad
Model 2841
Lot: see FSN

MD: Sterile wound irrigation solution; Eye pad

de

fr

en

Vk_20170310_05
20.03.2017 Respironics California Inc

V60 Ventilator
Model 850008
Software Version: 2.20

MD: Ventilator

de

fr

en

Vk_20170308_03
20.03.2017 Gambro Lundia AB

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

en

Vk_20170307_06
20.03.2017 CareFusion

Biopsy, Aspiration, Bone Marrow needles and kit

MD: Manometer Tray, Jamshidi Needle Biopsy, Illinois (TJ) Needle Aspiration, Jamshidi (TJ) Needle Bone Marrow, Thoracentesis/Paracentesis Kit

de

en

Vk_20170313_10
20.03.2017 Storz Karl GmbH & Co

FLIPPTACK, Fixationsbutton
Model 28729FT
Lot: 61603728, 61603837, 61603844, 61700023, 61700063, 61700154

MD: Orthopaedic bone screw, non-bioabsorbable, sterile

de

fr

it

Vk_20170313_08
20.03.2017 Zimmer CAS

iAssist Validation Tool/SmartTools Knee System
Model 20-8011-021-00
Lot: 130542A1;1405941;140146;140146-1;140147;140407A;140407A-1;140407B;140407-B-1;140860;140860-1;141035;150120;B150120;B150711

MD: Total knee prosthesis implantation guide-instrument kit

de

fr

it

en

Vk_20170313_04
20.03.2017 JJGC Industria e Comercio de Materiais Dentarios SA - NEODENT

CM Exact Intra oral scanbody
Model 108.139
Lot: 56390; 71065; 71069

MD: Dental implant suprastructure, temporary, single-use

en

Vk_20170308_19
20.03.2017 Sysmex Corporation

Automated Hematology Analyzer XN-L series
Model XN-550
S/N: All

IVD: Haematology analyser

de

fr

it

Vk_20170309_01
20.03.2017 Hitachi High-Technologies

cobas 8000 ISE module 900 / 1800
Model see letter
S/N: see letter

 

cobas c 311 / 501 / 502 / 701 / 702
Model see letter
S/N: see letter

IVD: Ion-selective analyser IVD, automated; Laboratory multichannel clinical chemistry analyser IVD, automated

de

fr

it

en

Vk_20170308_12
20.03.2017 Siemens Healthcare GmbH; Business Area Advanced Therapies

Artis Q/Q.zen
S/N: Artis Q systems with A100G generators

MD: Stationary angiographic x-ray system, digital

de

fr

Vk_20170308_11
20.03.2017 Paul Hartmann AG

Vivano Med Abdominal Kit
Model 4097201, 4097202, 4097203, 4097204
Lot: see fsn

MD: Negative-pressure wound therapy system dressing set

de

fr

Vk_20170309_08
20.03.2017 Physio-Control Corporation

LIFEPAK 1000 Defibrillator
Model 320371500XXX, 99425-000XXX

MD: Non-rechargeable public semi-automated external defibrillator

de

fr

it

en

Vk_20170307_12