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Schweizerisches Heilmittelinstitut

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Medizinprodukte: Rückrufe und andere Sicherheitsmassnahmen (FSCA)


Datum / Date	Hersteller / Fabricant	Handelsname / Nom commercial	Beschreibung des Produktes / Description du produit	Information	Swissmedic Ref.
14.05.2012	Zimmer, Inc.	NexGen Cruciate Retaining (CR) Micro Articular Surface Model see letter Lot: all	MD: Tibial insert	Deutsch Français Italiano	Vk_20120320_06
14.05.2012	Siemens Healthcare Diagnostics Inc	ADVIA Centaur HCV (aHCV) assay Model 03438099 Lot: 79119226, 79135226, 79643226, 79713226, 79700227, 80059227, 80128227, 80472227, 80934228, 81130228, 81273228, 81436228, 82023228, 82380228, 82823228, 83375229, 83678229, 83715229, 84080229, 84248229, 84770229, 85259229, 85586229, 85865229	IVD: Hepatitis C virus immunoglobulin G kit	Deutsch Français English	Vk_20120508_15
14.05.2012	Karl Beese GmbH & Co	Unsterile gauze products (gauze swabs, gauze balls, lap sponges) with X-ray thread Lot: all	MD: Unsterile gauze products with X-ray thread	Deutsch/English	Vk_20120427_01
14.05.2012	Becton Dickinson Diagnostic Systems	BD Phoenix 100 Instrument Model 448100 BD Phoenix System Software Model 448035, 448046 Software Version: 5.55R, 5.66A, 5.70A, 5.75A, 5.83A, 6.01A BD Phoenix Update Disks (PUD), Model 441107, 448047 Software Version: 4.51R, 4.65G, 4.61A, 4.65A, 4.71A, 4.75A, 4.81A, 4.91A, 5.11A, 5.15A, 5.21A	IVD: Analyser, microbiology	Deutsch Français Italiano English	Vk_20120509_11
14.05.2012	Elekta CMS Software	XiO Model All Lot: All Software Version: 4.30.00 - 4.64.00	MD: Radiation therapy treatment planning system application software	English	Vk_20120511_01
14.05.2012	Siemens Healthcare Diagnostics Products Limited	IMMULITE / IMMULITE 1000 Insulin Model LKIN1, SMN 10381429 Lot: 0335 IMMULITE 2000 / 2000 Xpi Insulin Model L2KIN2, SMN 10381455 Lot: 312, 313, 314, 315, 316	IVD: Insulin kit	English	Vk_20120509_05
14.05.2012	Smith & Nephew Orthopaedics AG	RT-PLUS MODULAR Tibial Stepped Drill and RT-PLUS MODULAR Tibial Drill Guide Model 240445 (75015047) / 240449 (75015051) Lot: 240445: D76247, D76706 / 240449: D76272, D76707	MD: Guide, drill	Deutsch English	Vk_20120508_12
14.05.2012	Siemens Healthcare Diagnostics Products Limited	IMMULITE 2000, IMMULITE 2000 Xpi Erythropoietin Model L2KEPN2/6 Lot: 216, 217, 218, 219, 220 IMMULITE 2500 Erythropoietin Model L5KEPN2 Lot: 216, 217	IVD: Erythropoietin kit	English	Vk_20120509_01
14.05.2012	Dr. Arabin GmbH	Cerclage Pessary Type ASQ Model ASQ 70/21/35 Lot: W 33/11/2	MD: Pessarie	Deutsch English	Vk_20120426_05
14.05.2012	Synthes GmbH	MIRS, Synthes Minimally Invasive Reduction Screw System Model Technique Guide: 036.001.341	MD: Bone-screw internal spinal fixation system	English	Vk_20120508_10
14.05.2012	Siemens Healthcare Diagnostics Inc.	Dimension Vista LOCI CA19-9 Flex reagent cartridge Model K6457 Lot: 11223AC, 12054BC, 12072BA, 12107AB	IVD: Cancer antigen 19-9 kit	English	Vk_20120509_08
14.05.2012	Elekta Limited Linac House	XVI Model MRT 13591/MRT 13221 Software Version: 4.5	MD: Digital imager, radiation therapy	English	Vk_20120510_11
07.05.2012	Nikkiso Europe GmbH Update	Aquarius with RCA Model GEF09500 / GEF09600 with installed upgrade kit BG-F700-xx S/N: all Software Version: 6.01	MD: Haemofiltration system	Deutsch Deutsch Update Français Français Update Italiano Italiano Update English English Update	Vk_20111115_07
07.05.2012	Abbott GmbH & Co. KG Update	ARCHITECT Active-B12 (Holotranscobalamin) Model 3P24-25, 3P24-35 Lot: 10112UP00, 10113UP00, 10131UP00, 10153UP00, 10182UP00 and above, 10146UP00 and above	IVD: Vitamin B12 kit	Deutsch Update Deutsch 2 Update Deutsch Français Update Français Italiano Update Italiano 2 Update Italiano English Update English 2 Update English	Vk_20120112_01
07.05.2012	DiaSys Diagnostic System GmbH	oneHbA1c FS / oneHbA1c IS Model 1 3329(..)	IVD: Glycosylated haemoglobin kit	Deutsch English Français	Vk_20120501_02
07.05.2012	IDEV Technologies	Supera Veritas Self-Expanding Nitinol Stent Peripheral Vascular & Biliary System Model All S/N: All	MD: Stent, vascular	Deutsch English	Vk_20120417_11
07.05.2012	Q-Med Esthetics	Macrolane Model 10-60721, 10-60821, 10-60761, 10-60861, 10-60521, 10-60621, 10-60561, 10-60661	MD: Synthetic-fluid tissue reconstructive material	Deutsch Français English English 2	Vk_20120504_06
07.05.2012	STRYKER Ireland Ltd	ABGII Modular Stems & ABGII Modular Necks and Rejuvenate Modular Stems & Rejuvenate Modular Necks Model See FSN	MD: Hip prosthesis cement restrictor	English	Vk_20120507_01
07.05.2012	Ortho-Clinical Diagnostics Inc.	VITROS 5600 Software Version: 1.6 and below	IVD: Clinical chemistry analyser	Deutsch English	Vk_20120501_10
07.05.2012	Baxter Healthcare SA	Floseal Hemostatic Matrix Model 1501510 Lot: all	MD: Collagen haemostatic agent	Deutsch Français Italiano English	Vk_20120412_02
07.05.2012	Baxter Healthcare SA	Infusor / Intermate / FOLFusor Model see FSN Lot: all	MD: Elastomeric infusion pump system	Deutsch Français Italiano	Vk_20120328_06
07.05.2012	Philips Medical Systems (Cleveland) Inc.	Brilliance 6, Brilliance 16, Brilliance 40, Brilliance 64, Brilliance CT Big Bore, iCT, iCT SP and Ingenuity CT Model 728256, 728246, 728235, 728231 , 728243, 728244, 728306, 728311, 728326 S/N: see FSN	MD: Full-body CT system	Deutsch Français English	Vk_20120501_01
07.05.2012	Teleflex Medical Tuttlingen GmbH	Duisburger Hollow Screw for Subdural Puncture Model LH1540N Lot: H1 / I1	MD: Drain	Deutsch Français Italiano English	Vk_20120501_04
07.05.2012	Philips Medical Systems DMC GmbH	DigitalDiagnost Model 712020 & 712022 S/N: All systems with software version 2.x and stitching option Software Version: 2.x	MD: General-purpose radiography digital imaging system	Deutsch Français Italiano English	Vk_20120501_03
07.05.2012	Medtronic Osteotech Inc.	Grafton DBM Putty, Grafton DBM Gel, Grafton DBM Flex, Grafton DBM A-FlexTM, Grafton DBM Crunch, Grafton DBM Matrix PLF, Grafton DBM Matrix Strips, Grafton DBM Orthoblend, Grafton Plus DBM Paste Model see FSN Lot: see FSN Xpanse R and Xpanse S Model see FSN Lot: see FSN	Devitalized MD: Bone, graft, substitute	Deutsch Français English	Vk_20120425_22
30.04.2012	Radiometer Medical ApS Update	ABL505/555, EML105, ABL600, ABL700 Series, ABL800	IVD: Blood gas/pH/electrolyte/metabolite analyser	Deutsch Update Deutsch Français Update Français Italiano Update Italiano English	Vk_20110420_15
30.04.2012	GE Medical Systems LLC	Optima MR450W with GEM option Model 5410917	MD: Full-body MRI system, superconducting magnet	Français	Vk_20120330_02
30.04.2012	Smith & Nephew Inc. Orthopedic Division	Various Trauma Half Pins, Pins, Drill Bits, Tap, Trocar Model see FSN Lot: see FSN	MD: Fixation device	Deutsch Français English	Vk_20120425_21
30.04.2012	Philips Medical Systems DMC GmbH	MammoDiagnost DR Model 714040	MD: Radiographic unit, mammographic	Deutsch English	Vk_20120426_07
30.04.2012	DePuy Leeds UK; DePuy France	FJORD Cemented Standard Femoral Stem Model See FSN Lot: all G2 Stem Cemented Model See FSN Lot: all G2 Stem uncemented Model See FSN Lot: all	MD: Press-fit hip femur prosthesis, modular; Uncoated hip femur prosthesis, modular	Deutsch Français English	Vk_20120425_14
30.04.2012	DiaMed GmbH	IH-Com Full kit version (Data Management and Result Interpretation Software) Model 009000 Software Version: 03.0.43 / 03.0.52 / 03.0.59	IVD: Blood grouping system, automated	English	Vk_20120424_05
30.04.2012	Doctors Research Group, Inc. (DRG)	Kryptonite Bone Cement / Kryptonite-X Radiopaque Bone Cement (Kryptonite) Model KRYP-Z-10, KRYP-Z-05, KRYP-X-10, KRYP-X-05, 52-702-05-04, 52-702-10-04 Lot: 04012011, 05182011, 11172011, 06082011, 09082011,12132011, 02092011, 04042011, 05122011, 07262011,08232011, 12012011, 04082011, 08052011, 10182011,12122011, 10192011, 09192011	MD: Bone matrix implant, synthetic	English	Vk_20120425_04
30.04.2012	Siemens Shenzhen Magnetic Resonance Ltd.	MAGNETOM ESSENZA Model 10352127	MD: Superconducting-magnet breast MRI system	Deutsch English	Vk_20120425_12
30.04.2012	Johnson & Johnson International	Ethipin Model see FSN Lot: see FSN PDS Cord; PDS Cord II Lot: see FSN	MD: Orthopaedic bone pin, biodegradable; Surgical support tape, bioabsorbable	Deutsch Français Italiano	Vk_20120425_13
30.04.2012	Elekta Limited Linac House	MLCi and MLCi2 Model MRT 2421; MRT 14401	MD: Free (unbound) prostate specific antigen (PSA) IVD, calibrator	Deutsch Français Italiano English	Vk_20120426_06
23.04.2012	St. Jude Medical	QuickSite Model 1056T; 1058T S/N: All QuickFlex Model 1156T; 1158T S/N: All	AIMD: Endocardial pacing lead	Deutsch Français Italiano English	Vk_20120416_02
23.04.2012	Terumo Cardiovascular Systems	Terumo Advanced Perfusion System 1 (APS1) Model 801764 S/N: 0006 to 1422	MD: Cardiopulmonary bypass system roller pump	Deutsch Français English	Vk_20120417_13
23.04.2012	GE Medical Systems SCS	READY View application Available on AW4.6 and AW Server II Software Version: 10.3.67	MD: Radiology picture archiving and communication system workstation	Deutsch Français Italiano	Vk_20120418_06
23.04.2012	Abbott Laboratories	ARCHITECT STAT Troponin-I Reagent Model 2K41-28 Lot: 74264UN11	IVD: Immunoassay method, troponin subunit	Deutsch Français English	Vk_20120418_07
23.04.2012	Activaero GmbH	AKITA JET Model 01RS0100 S/N: see letter Lot: see letter	MD: Aerosol inhaler	Deutsch Français Italiano English	Vk_20120418_08
23.04.2012	Waldemar Link GmbH & Co. KG	LINK Endo-Model SL Rotational and Hinge Knee Prosthesis System, Connection Component, Rotational Version Model 16-2840/02; 16-2840/05; 16-2840/07 Lot: production dates between 02-2011 and 02-2012	MD: Rotating hinged total knee prosthesis	Deutsch English	Vk_20120417_12
23.04.2012	Philips Healthcare	Brilliance CT 64 Model 728231 S/N: see letter Software Version: 3.5.1 Ingenuity CT Model 728326 S/N: see letter Software Version: 3.5.1	MD: Full-body CT system	Deutsch Français Italiano English	Vk_20120418_04
23.04.2012	Beckman Coulter Inc.	UniCel DxH 800 Coulter Cellular Analysis System Model PN(s): 629029 S/N: All serial numbers Lot: Not applicable	IVD: Haematological cell analyser IVD, automated	Deutsch Français English	Vk_20120417_04
23.04.2012	Advanced Sterilization Products	Sterrad CycleSure 24 Biological Indicator Model 14324 Lot: 227118	MD: Biological sterilization process indicator	Deutsch English 1 English 2	Vk_20120419_01
23.04.2012	Philips Medical Systems BV	MultiDiagnost Eleva FD Model 708034 Software Version: R5.1.x	MD: Stationary general-purpose fluoroscopic x-ray system, analogue	Deutsch Français English	Vk_20120418_01
16.04.2012	Advanced Sterilization Products Update	STERRAD steriliser Model 200	MD: Plasma sterilizer	Deutsch English Update English	Vk_20120201_06
16.04.2012	Etac Supply Center AB	Avant LW Model Avant LW Salsa Model Salsa Walker Avant Model Walker Avant	MD: Basic walker, non-foldable	Deutsch Français Italiano English	Vk_20120315_11
16.04.2012	Intuitive Surgical	da Vinci Surgical Systems User Manuals	MD: Robotic surgical system	English	Vk_20120404_07
16.04.2012	Intuitive Surgical	da Vinci Tip Cover Accessory Model 400180-10 and prior versions 400180-01, 400180-02, 400180-03, 400180-04, 400180-05, 400180-06, 400180-07, 400180-08 and 400180-09 Lot: Applies to all lot numbers for the part number/versions listed above	MD: Electrosurgical diathermy system monitor/shield	English	Vk_20120404_08
16.04.2012	Beckman Coulter Inc.	Access Vitamin B12 Model Part Number: 33000 Lot: 170089	IVD: White blood cell count IVD, reagent	Deutsch Français English	Vk_20120411_03
16.04.2012	Roche Diagnostics Ltd	AMPLILINK Software for COBAS AmpliPrep/COBAS TaqMan Model 05666678001 Software Version: 3.2	IVD: Sample processing system	English 1 English 2 Deutsch 1	Vk_20120404_10
16.04.2012	Gambro Industries	Prisma ST set Model see letter Lot: see letter Prismaflex ST set Model see letter Lot: see letter	MD: Haemofilter	Deutsch Français Italiano English	Vk_20120411_05
16.04.2012	Siemens Healthcare Diagnostics Inc.	Stratus CS Acute Care NT- proBNP TestPak Model CPBNPM Lot: 211214002, 211227002, 211283002, 211297002, 211339002, 212003002 and 212023002	IVD: BNP / pro BNP - Rapid Test (including other Natriuric Peptides)	Français English	Vk_20120411_09
16.04.2012	Siemens Healthcare Diagnostics Inc.	Dimension Vista Total Prostate Specific Antigen Model K6451 S/N: 11300BB	IVD: Total prostate specific antigen (PSA) IVD, reagent	Français English	Vk_20120411_10
16.04.2012	Cordis Corporation	Cordis S.M.A.R.T. Control Nitinol Stent System Model C06060SV, C06080SV, C06100SV, C07040SV, C07060SV, C7080SV, C08060SV, C08080SV, C09040SV, C09060SV, C09080SV, C10040SV, C10060SV, C10080SV, C12040MV Lot: See list S.M.A.R.T Nitinol Stent System Model C06120MV, C06120SV, C06150MV, C06150SV, C07120MV, C07120SV, C07150MV, C08150MV Lot: See list	MD: Biliary/peripheral artery stent; Iliac artery stent	Deutsch Français English	Vk_20120411_08
16.04.2012	Instrumentation Laboratory Co.	HemosIL von Willebrand Factor Activity Model 0020004700 Lot: B01424; B11498; B11655; B11687	IVD: Coagulation factor von Willebrand RCO	English	Vk_20120411_02
16.04.2012	Varian Medical Systems Inc	4D Integrated Treatment Console (4DITC) Model H51 Software Version: 8.1.3x to 8.8x	MD: Linear accelerator system	Deutsch Français Italiano English	Vk_20120412_01
16.04.2012	Baxter Healthcare Corp. Renal Division	HOMECHOICE AUTOMATED PD SET W/CASS.-4 PRONG, EUR. Model R5C4455, R5C4479 HomeChoice Automated PD Set with Cassette 8-Prong Model R5C4478 5-Prong Manifold Set with System II Connectors Model R5C4427	MD: Peritoneal dialysis system tubing set	Deutsch Français Italiano	Vk_20120416_03

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Datum
Zeitspanne der Publikation

Date
Période de la publication
Handelsname
LOT: von der Massnahmen betroffene Chargennummern
S/N: von der Massnahme betroffene Seriennummern

Nom commercial
LOT: numéros de lots concernés par la mesure
S/N: numéros de série concernés par la mesure
Beschreibung des Produktes / Description du produit

AIMD: Active Implantable Medical Device
IVD: In Vitro Diagnostic
MD: Medical Device
Information

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