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Medical devices: List of recalls and other field safety corrective actions (FSCA)


Datum / Date	Hersteller / Fabricant	Handelsname / Nom commercial	Beschreibung des Produktes / Description du produit	Information	Swissmedic Ref.
06.09.2010	Karl Storz GmbH & Co. KG	Calcuson & Endomat LC used in combination, suction tubing set Model 20330342	MD: Suction system tubing	Deutsch	Vk_20100825_07
06.09.2010	Varian Medical Systems Inc	VARIAN Treatment Model H46 Software Version: 6.6.5034, 6.6.5042, 6.6.5043, 6.6.5046, and 6.6.5048 actively using the Digital Mevatron Interface Protocols(DMIP) 5 or 6	MD: Radiation therapy treatment record/verify system	Deutsch Français Italiano English	Vk_20100902_05
06.09.2010	Swissimplant AG Update	Solysafe Septal Occluder Model: Type 15 - REF 010.0001 Type 20 - REF 010.0002 Type 25 - REF 010.0003 Type 30 - REF 010.0004 Type 35 - REF 010.0005 Lot: All	MD: Cardiac occluder	Update English Deutsch Français Italiano	Vk_20100806_01
06.09.2010	Ortho-Clinical Diagnostics Inc.	VITROS Chemistry Products mALB Reagent, Generations 2, 3 and 4 Model 6801740	IVD: Albumin kit	Deutsch Update Deutsch English Update English	Vk_20100831_10
30.08.2010	Optovue, Inc.	iVue Model iVue100 Software Version: 1.5	MD: Ophthalmoscope	Deutsch Français Italiano English	Vk_20100825_02
30.08.2010	Haag-Streit AG	Tonometermesskörper	MD: Tonometer, manually-operated	Deutsch Français Italiano English	Vk_20091216_15
30.08.2010	TRUMPF Medizin Systeme GmbH	incarePORT klinoPORT	MD: Utility supply system, ceiling-mounted	Deutsch English	Vk_20100817_18
30.08.2010	Procter & Gamble Technical Centres Ltd	Kukident Super-Haftcreme extra stark Model Lot: 0203 xxx xxx	MD: Denture lining materials / adhesive (Prothesenhaftmittel)	Deutsch Français Italiano	Vk_20100824_12
30.08.2010	Varian Medical Systems Inc	Optical Guidance Platform (OGP) Model HZ1 S/N: See List	MD: Stereotactic-radiosurgical linear accelerator system	Deutsch Français English	Vk_20100826_02
30.08.2010	Varian Medical Systems Inc	Eclipse Treatment Planning System Model H48 Software Version: 7.3.10 through 8.6.15	MD: Radiation therapy treatment planning system	Deutsch Français Italiano English	Vk_20100825_09
30.08.2010	DePuy International Limited	ASR Articular Surface Replacement and ASR XL Monoblock Metal-on-Metal System	MD: Femoral Component and Acetabular Component	Deutsch Français Italiano	Vk_20100826_06
30.08.2010	Planmeca Oy	Planmeca Compact	MD: Dental delivery system	Deutsch Français Italiano English	Vk_20100825_08
30.08.2010	Johnson & Johnson AG Medical	1 DAY ACUVUE TruEye Lot: see Letter	MD: Contact lens	Deutsch Français Italiano English	Vk_20100826_05
30.08.2010	Synthes GmbH	Implant Holder f/SynFix-LR Model 03.802.039 Lot: All	MD: Orthopaedic implant/trial-implant holder	Deutsch Français English	Vk_20100824_13
23.08.2010	Philips Medical Systems	HeartStart MRx Model M3535A / M3536A / M3536J/ M3536MC S/N: see letter	MD: Defibrillator/monitor	Deutsch Français Italiano English	Vk_20100819_03
23.08.2010	BrainLAB AG Update	KOLIBRI Navigation Station 2.0 (with mobile camera stand 2.0)	MD: Robotic surgical system, navigation	Deutsch Update Deutsch English Update English Français Italiano	Vk_20100727_01
23.08.2010	Dräger Medical AG & Co.	Oxylog 3000 S/N: see letter	MD: Transport ventilator	Deutsch	Vk_20100819_01
23.08.2010	Roche Diagnostics GmbH	Tina-quant D-Dimer Gen. 2 Model 04912497190, 04912551190, 05077753190 Lot: 62838001, 62837701, 62841101	IVD: D-dimer kit	Deutsch Français English	Vk_20100817_13
23.08.2010	Nova Biomedical	Nova Biomedical Ionized Calcium Sensor Model 15264, 27813, 37272, 42458 Nova Biomedical Ionized Magnesium Sensor Model 15265, 37271, 45172	IVD: Calcium electrode, Magnesium electrode	English	Vk_20100817_16
23.08.2010	Accuray Inc.	CyberKnife Robotic Radiosurgery System	MD: Linear accelerator system	Deutsch Français Italiano	Vk_20100817_17
23.08.2010	Schülke & Mayr GmbH	thermosept alka clean forte / thermosept NKZ Lot: all	MD: Detergent	Deutsch Français Italiano English	Vk_20100818_15
23.08.2010	CIBA Vision Corporation	FreshLook Colors Model Sappire Blue, Violet Lot: Sapphire Blue Lot: 304980, 312944; Violet Lot: 302592	MD: Contact lens	Deutsch	Vk_20100817_05
23.08.2010	Allergan Medical S. A.	Easyband Model Version 3 S/N: see list Easyband Model Gen 0 S/N: see list Software Version: FIM 05023 Easyband Model Version 2 S/N: see list	AIMD: Gastric band	English1 English2	Vk_20100817_07
23.08.2010	Zimmer GmbH	Wallaby I PE-Inlay ultra-congruent, Model see List Lot: up to 2249344 Wallaby I PE-Inlay normo-congruent, Model see List Lot: up to 2249344	MD: Knee prosthesis, internal, tibial component	Deutsch Français	Vk_20100809_01
23.08.2010	Philips Medizinsysteme	Water trap for IntelliVue Anesthetic Gas Modules - G1/G5 Model M1657B Lot: see letter	MD: Patient monitoring system module, multiple-gas	Deutsch Français English	Vk_20100819_02
16.08.2010	BioMérieux SA	VIDAS RUB IgG II Model 30221 Lot: 837810801	IVD: Rubella virus immunoglobulin G kit	Deutsch Français	Vk_20100811_05
16.08.2010	Elekta CMS Software	Focal Software Version: Release 4.50.00 and higher	MD: Radiation therapy treatment planning system	English	Vk_20100804_04
16.08.2010	3M Health Care	3M Red Dot Monitoring Electrode with Foam Tape and Sticky Gel Model 2560 Lot: 2012-05-CC, 2012-05-CD, 2012-05-CE, 2012-05-CF, 2012-05-CG,2012-05-CH, 2012-05-CI, 2012-05-CJ, 2012-05-CK, 2012-05-CM2012-05-CN, 2012-06-CY, 2012-06-CZ, 2012-06-DA, 2012-06-DB.	MD: Electrode	Deutsch1 Deutsch2 Français1 Français2 English1 English2	Vk_20100812_09
16.08.2010	DiaSorin Deutschland GmbH	LIAISON Analyzer Model 9450200 S/N: all LIAISON LAS Analyzer Model I0041 S/N: all	IVD: Analyser, laboratory, immunoassay, chemiluminescent	Deutsch Français English	Vk_20100810_10
16.08.2010	Abbott Laboratories	CELL-DYN Sapphire Vent Head Assembly Model 08H53-02 CELL-DYN Sapphire Accessory Kit Model 08H03-01 CELL-DYN Sapphire Model 08H00-01	IVD: Haematology analyser, cell-differential	Deutsch Français	Vk_20100812_05
16.08.2010	Abbott Point of Care	i-STAT Level 2 Control Lot: B09342, B09154	IVD: Blood gas control	Deutsch Français English	Vk_20100811_02
16.08.2010	DePuy International Limited	DePuy Summit Universal Broach Handle Model 257000000 Lot: A1109, A1209, A0210 and A0310	MD: Surgical instrument handle	English	Vk_20100810_04
16.08.2010	Stryker Orthopaedics	Scorpio T72 Tibial Insert Trial Model T72-2, T72-3, T72-5, T72-6 Lot: All	MD: Trial joint prosthesis	Deutsch1 Deutsch2	Vk_20100813_04
09.08.2010	Integra LifeSciences (Ireland) Ltd.	CUSA NXT Service Module Model CUSANXT2 S/N: NXT1022	MD: Trolley, electromechanical device	English	Vk_20100803_13
09.08.2010	Ortho-Clinical Diagnostics Inc.	VITROS 3600 Software Version: 1.4 and below VITROS 5600 Software Version: 1.4 and below	IVD: Clinical chemistry analyser Immunoassay analyser	Deutsch English	Vk_20100804_05
09.08.2010	Beckman Coulter Inc.	UniCel DxI 600 Access Immunoassay System Software Version: 4.3 UniCel DxI 800 Access Immunoassay System Software Version: 4.3	IVD: Immunoassay analyser	Deutsch English Français	Vk_20100805_03
09.08.2010	Beckman Coulter Inc.	Access Thyroglobulin Antibody II Reagent Model A32898 Lot: 916271, 917073, 918433	IVD: Thyroglobulin autoantibody kit	Français English	Vk_20100805_05
09.08.2010	Bio-Rad Laboratories Deeside	in2it (I) A1c Test Cartridges Model 281-0001EX Lot: all in2it (II) A1c Test Cartridges Prescription Home Use Model 281-0001 Lot: all in2it A1c Test Cartridges Self Test Model 281-0001ST Lot: all	IVD: Glycated haemoglobin kit	English	Vk_20100803_14
09.08.2010	MammendorferInstitut für Physik und Medizin GmbH	Tesla Plus Model EFTES03D S/N: MIMT980031	MD: Patient monitoring system, general physiology, multi-patient	Deutsch English	Vk_20100804_03
09.08.2010	Becton Dickinson Diagnostic Systems	BD BBL Staphyloslide Latex Test Model 240952 Lot: 16604110, 16605410, 16640910, 16679310, 16750910, 16778710, 16781210, 16831557	IVD: Streptococcus antigen kit	Français	Vk_20100727_26

recallTable.infolist.legende

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

Kopie des Informationsbriefes (wenn vorhanden in den verschiedenen Landessprachen, sonst auf Englisch)

Copie des lettres d'information (si disponibles dans les langues nationales, sinon en anglais).

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