Dispositifs médicaux

Nom Classification Fabricant Classe de risque Pays Source
Trade name: Vidas 3 Technical name: Lives 3 ANVISA registration number: 10158120679 Hazard class: I Affected name: Not applicable bioMérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda.; bioMérieux S.A. Brazil
Trade name: GRAFTYS BCP Technical name: ENZYME OSSEO ANVISA registration number: 80517190002 Hazard class: I Target affected: Not applicable LAS LATIM AMERICAN SOLUTIONS IMPORTAÇÃO E EXPORTAÇÃO LTDA; GRAFTYS SARL Brazil
Technical name: MAMMAL IMPLANTS ANVISA registration number: 80674930007 Risk class: III - High Risk Affected models: See alert on Anvisa Portal EUROSILICONE BRASIL IMPORTAÇÃO E EXPORTAÇÃO LTDA; EUROSILICONE S.A.S. Brazil
Xpert BCR-ABL Monitor Technical Name: Chromosomal Translocation BCR-ABL Registration Number ANVISA: 81062710016 Hazard Class: III Affected Models: Kit with 10 tests (cartridges with integrated reaction tubes) Serial numbers affected: 1000040993 CEPHEID BRASIL IMPORTAÇÃO, EXPORTAÇÃO E COMÉRCIO DE PRODUTOS DE DIGANÓSTICOS LTDA.; CEPHEID Brazil
Trade Name: SISTEMA ESSURE Technical Name: Female Contraceptive Devices ANVISA Registration Number: 80274190001 Hazard Class: IV - Maximum Risk Affected Models: ESS305 Affected Lot Numbers: All lots Comercial Commed Produtos Hospitalares Ltda; Bayer Health Care LLCI Brazil
ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 80015490090 Hazard Class: III Affected Model: Artis Zee Ceiling, Artis Zee Floor, Artis Zee biplane, Artis Zeego, Artis Q biplane Siemens Healthcare Diagnósticos S.A; Siemens AG Brazil
Product name: Defibrillator Hearstart MRx, Philips brand Technical Name: Defibrillator ANVISA Registration Number: 10216710136 Hazard Class: III Affected Model: M3535A, M3536A Cardiovascular Devices Philips Medical Systems Ltda.; Philips Medical Systems. Brazil
Full name: System for total femoral-tibial-patellar multi-compartment total arthroplasty ANVISA registration number: 80102511373 Hazard class: III Affected model: Ceramic alumina heads 36 mm Series numbers affected: 0211313520; 0311327277; 0311337209; 1555038; 1648756; 1650634; 1633531; 1648754; 1602583; 1655960; 1668359; 1655972; 1655960; 1648759; 1655972; 15541511687588; 15546491621617; 14519031660611; 1555037; 1684826; 1633530; 1656049; 0656748101; 016316886; 065: 05810312; 085: 05810102; 0557332101; 0657633801; 0556748101; 1648801. VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; MICROPORT ORTHOPEDICS INC. Brazil
CERTOFIX DUO V 720 JUG 7F and CERTOFIX DUO V 730 SUB 7F Technical name: FAMILY OF CENTRAL VENOUS CATHETERS ANVISA Registration Number: 80136990671 Hazard Class: IV Affected Model: 4161211 and 4161319 Serial Numbers Affected: 16M15A8551 and 16M21A8551 Laboratórios B. Braun S.A.; B. Braun Melsungen AG Brazil
alinity work module and processing module Abbott Poland
CELL-DYN RUBY Technical Name: HEMATOLOGICAL ANALYZER ANVISA Registration Number: 80146501507 Hazard Class: II Affected Model: Not applicable Serial Numbers Affected: 70002BG; 70026BG; 70050BG; 70076BG; 70105BG; 70141BG; 70003BG; 70028BG; 70051BG; 70077BG; 70106BG; 70142BG; 70004BG; 70029BG; 70052BG; 70079BG; 70107BG; 70144BG; 70005BG; 70030BG; 70054BG; 70082BG; 70113BG; 70146BG; 70006BG; 70031BG; 70056BG; 70084BG; 70114BG; 70147BG; 70007BG; 70032BG; 70058BG; 70086BG; 70119BG; 70149BG; 70008BG; 70033BG; 70059BG; 70087BG; 70120BG; 70164BG; 70009BG; 70034BG; 70061BG; 70088BG; 70124BG; 70165BG; 70010BG; 70035BG; 70063BG; 70089BG; 70125BG; 70166BG; 70011BG; 70036BG; 70064BG; 70090BG; 70127BG; 70167BG; 70012BG; 70037BG; 70065BG; 70091BG; 70129BG; 70170BG; 70013BG; 70038BG; 70067BG; 70092BG; 70130BG; 70171BG; 70014BG; 70039BG; 70068BG; 70093BG; 70131BG; 70178BG; 70016BG; 70040BG; 70069BG; 70094BG; 70132BG; 70181BG; 70018BG; 70042BG; 70070BG; 70095BG; 70133BG; 70183BG; 70019BG; 70043BG; 70071BG; 70096BG; 70134BG; 70189BG; 70020BG; 70044BG; 70072BG; 70099BG; 70136BG; 70021BG; 70045BG; 70073BG; 70100BG; 70137BG; 70024BG; 70046BG; 70074BG; 70103BG; 70138BG; 70025BG; 70047BG; 70075BG; 70104BG; 70140BG. Abbott Laboratórios do Brasil; ABBOTT LABORATORIES Brazil
Endodontic Endodontic System II - Endoprosthesis System Technical Name: Vascular Endoprosthesis ANVISA Registration Number: 10339190330/10339190508 Hazard Class: IV Model Affected: ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C145EE; ENBF2513C170EE; ENBF2516C145EE; ENBF2516C170EE; ETBF2313C124E; ETBF2313C124EE; ETBF2313C145EE; ETBF2313C166E; ETBF2313C166EE; ETBF2316C124EE; ETBF2316C145EE; ETBF2316C166E; ETBF2316C166EE; ETBF2513C124EE; ETBF2513C145EE; ETBF2513C166EE; ETBF2516C124EE; ETBF2516C145E; ETBF2516C145EE; ETBF2516C166E; ETBF2516C166EE. MEDTRONIC COMERCIAL LTDA; MEDTRONIC IRELAND; MEDTRONIC MEXICO; MEDTRONIC INC Brazil
Commercial Name: Brightview XCT Image System Technical Name: Equipment Positron Emission Tomography ANVISA Registration Number: 10216710189 Hazard Class: III Model Affected: Serial Numbers Affected: 6000276 Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc. / Philips Medical Systems Ltda. Brazil
Name of Elecsys TSH and Elecsys PTH (1-84) Technical Name: THYROID STIMULATING HORMONE (TSH) and INTACT CATHOLIC HORMONE (iPTH) ANVISA Registration Number: Hazard Class: II Model Affected: Serial Numbers Affected: 185522 Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH Brazil
Vitek MS V2.0 and Vitek MS V 3.0 - Clinical: Vitek MS V2.0 and Vitek MS V 3.0 - Clinical bioMérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda.; bioMérieux S.A. Brazil
Trade name: iChem VELOCITY Technical name: Urine Analyzer Instrument ANVISA Registration Number: 10033129046 Hazard Class: I Affected Model: Serial Numbers Affected: All instrument serial numbers in Brazil are affected by this notification. Beckman Coulter do Brasil Comércio e Importação de Produtos para Laboratório Ltda; IRIS Diagnostics a Division of Iris Internacional Inc. Brazil
Product name: Acetabular capsule for hip arthroplasty Registration number ANVISA: 10417940030 Hazard class: III Model affected: Acceptable MD4 Affected batches: 02243Q; 12803P; 10652Q; 10654Q. MDT Industria Comércio Importação e Exportação de Implantes S.A.; MDT Industria Comércio Importação e Exportação de Implantes S.A. Brazil
Technical Name: Linear Accelerator ANVISA Registration Number: 10234230125/10234230172/10234230073 Hazard Class: III Model Affected: Acceptable MD4 Serial numbers affected: 3221; 3229; 3554; 3585; 3589; 3655; 3787; 3857; 3889; 3903; 3911; 3913; 3927; 5065; 5103; 5197; 5288; 5302; 5312; 5344; 5389; 5422; 5484; 5524; 5542; 5637; 5669; 5677; 5697; 5770; 5788; 5885; 70-4118; 70-4203; 3598; 3752; 5508; 5509; 5526; 5287; 5529; 5386; 5746; 5828; 5867 Siemens Healthcare Diagnósticos S.A; Siemens AG; Siemens Medical Solutions USA, Inc. Brazil
ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 10345161980 Hazard Class: III Affected Model: Artis Zee Ceiling, Artis Zee Floor, Artis Zee Multi-purpose, Artis Zeego Serial Affected: 137159 Siemens Healthcare Diagnósticos S.A; Siemens AG Brazil
Trade name: LINEAR DIGITAL PRIMUS / MEVATRON ACCELERATOR Technical name: Linear Accelerator ANVISA registration number: 10234230073/10234230021 Hazard class: III Serial numbers affected: 2809; 2879; 2946; 3054; 1444; 1448; 1397; 1926; 2752; 2346; 2747 Siemens Healthcare Diagnósticos S.A; Siemens AG; Siemens Medical Solutions USA, Inc. Brazil
LOTUS VALVE SYSTEM Technical Name: Heart Valve Prosthesis ANVISA Registration Number: 10341350785 Hazard Class: IV Model Affected: H749LTV230; H749LTV270; H749LTV250 Boston Scientific do Brasil Ltda.; Boston Scientific Limited Brazil
Cobas® HIV-1 and HBV Technical Name: ANVISA Registration Number: Hazard Class: IV Model Affected: Registries: 10287411153 and 10287411154 Serial Numbers Affected: 1) cobas® HIV-1 Test (6979599190) Lot W11636 2 ) cobas® HBV Test (6979564190) Lot W14007 Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH Brazil
Trade name: LINEAR PRIMUS ACCELERATOR Technical name: Linear Accelerator ANVISA registration number: 10234230073 Hazard class: III Serial numbers affected: 5529; 5746; 5828 Siemens Healthcare Diagnósticos S.A; Siemens AG; Siemens Medical Solutions USA, Inc. Brazil
Trade name: Instrument for ophthalmologic microsurgery in stainless steel and polypropylene - Bisturis Technical name: Disposable syringe Registration number ANVISA: 80136060197 Hazard class: II Model affected: E7510; E7515; E7520; E7551ADB; E7552ADB; E7557A; E7600 Serial numbers affected: MDMY400; MDNH100; MAKG520; MAKC860; MAYX420; MASS190; MAJW650; MAJX600; MAJX800; MAJZ090; MAJY870; MDLP160; MDLV550; MDLV590; MDNA950; MDNA970; MDNA990; MDNF900; MAML400; MAMA910; MAML430; MAML450; MAKY340; MALJ120; MAMA790; MAML480; MAML490; MAWF650; MASC920; MDMV970; MAKC630; MAHV550; MAPX120; MAQB180; MAXZ130; MBLA630; MAKK210; MAKK230; MAMN140; MAXL020; MAMK320; MALW330; MAKK180; MAWH670; MAWF130. BL Industria Otica Ltda; BAUSHC & LOMB INCORPORATED Brazil
Trade Name: INTRA-AORTIC BALLOON PUMP Technical Name: Intra-Aortic Balloon Pump System ANVISA Registration Number: 10390690062 Hazard Class: III Model Affected: CARDIOSAVE Hybrid; CARDIOSAVE Rescue Serial numbers affected: 150468904PE and 150470604PE MAQUET CARDIOPULMONARY DO BRASIL INDUSTRIA E COMERCIO LTDA. Brazil