Devices

Name Classification Manufacturer Risk Class Country Source
Ultrasound Diagnostic System Technical Name: Ultrasound Device ANVISA Registration Number: 10295030071 Hazard Class: II Affected Model: TUS-X100, TUS-X100S, TUS-X200 and TUS-X200S Toshba Medical do Brasil; Toshiba Medical Systems Corporarion Brazil
Trade name: Valvulotome Hydro Longo Lemaitre ANVISA Registration Number: 80202919003 Hazard Class: II Affected Model: 1009-00 Serial Numbers Affected: ELVH1102V Tecmedic Comércio de Produtos Médicos Ltda; Lemaitre Vascular Inc Brazil
Technical Name: MINIMALLY INVASIVE INSTRUMENTAL SYSTEM AT ATQ ANVISA Registration Number: 80005430165 Hazard Class: I Affected Model: STRAWBERRY DOOR Affected serial numbers: T6318 Stryker do Brasil Ltda; Stryker Orthopaedics Brazil
Product Name: EON MINI NEUROSTIMULATION SYSTEM Technical Name: EON MINI NEUROSTIMULATION SYSTEM ANVISA Registration Number: 10332340246 Hazard Class: IV Hazard Class: 3788 St. Jude Medical Brasil LTDA; St. Jude Medical Brazil
Name: KIT STIMULATING KNIFE RECOMMENDED WITH STIMULATING PROBE NIM RESPONSE Technical Name: ENDOTRACHEAL / ELECTRODE CODE Registration Number ANVISA: 10173550046 Hazard Class: II Model Affected: M8229306K, M8229307K, M8229308K Richards do Brasil Produtos Cirúrgicos Ltda.; MEDTRONIC XOMED INC Brazil
Allura Xper Angiography Equipment Technical Name: Angiography Equipment ANVISA Registration Number: 10216710153 Hazard Class: III Model Affected: ALLURA XPER FD10 OR table; ALLURA XPER FD20 OR table; ALLURA XPER FD10 (ground); ALLURA XPER FD10 (ceiling); ALLURA XPER FD20 (ground); ALLURA XPER FD20 (ceiling) Serial numbers affected: 01H025418 Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V. Brazil
EliA CCP Well, EliA CCP Well, EliA CCP Well, EliA CCP Well, EliA IgG Conjugate, EliA IgG Conjugate 50, EliA IgG Conjugate 200, EliA CCP Positive Control 250, EliA CCP Positive Control 100 Conjugate 200, EliA CCP Positive Control 250, EliA CCP Positive Control 100 ANVISA Registration Number: 80254180068 Hazard Class: II Model Affected: 14-5515-01 (80254180068); 83-1005-01 (80254180059); 83-1017-01 (80254180067); 83-1018-01 (80254180128); 83-1035-01 (80254180113); 83-1040-01 (80254180116) Phadia Diagnosticos Ltda.; Phadia AB Brazil
GSP Genetic Screening Processor Technical Name: ANVISA Registration Number: 10298910108 Hazard Class: I Affected Model: 2021-0010 Affected serial numbers: 20210154, 20210207, 20210171, 20210163, 20210161, 20210208. PerkinElmer do Brasil Ltda.; Wallac Ou Brazil
Commercial Name: PROBE SAMPLE Technical Name: Sample Probe ANVISA Registration Number: 80145240438 Model Affected: PROBE SAMPLE; PROBE SAMPLE S; SAMPLE PROBE Roche Diagnóstica Brasil Ltda; Hitachi High-Technologies Corporation Brazil
Hygiene Technical Name: Modular System for Arthroplasty Total ANVISA Registration Number: 10417940085 Hazard Class: III Model Affected: Acetabular Insert PHENOM Poly (04.13.13.xxxxx) / Acetabular Insert PHENOM Poly Rear Ceiling (04.13.14.xxxxx) MDT Industria Comércio Importação e Exportação de Implantes S.A.; MDT Industria Comércio Importação e Exportação de Implantes S.A. Brazil
Trade name: ID-DIAPANEL P Technical name: IMMUNOHEMATOLOGY - ENZYME HEMACY / HEMATELIC REAGENTS Registration number ANVISA: 80004040131 Hazard class: IV Model affected: 004214V Serial numbers affected: 45171.88.1 DiaMed Latino América S.A Brazil
Trade name: GRAFTYS HBS Technical name: OSSEO ENZYME Registration number ANVISA: 80517190001 Hazard class: III Affected model: GYHBSV1Q5, GYHBSV1Q8, GYHBSV1Q16 LAS LATIM AMERICAN SOLUTIONS IMPORTAÇÃO E EXPORTAÇÃO LTDA; GRAFTYS SARL Brazil
Commercial Name: iPlan Surgical / Clinical Planning Software, Brainlab and Brainscan Brand Technical Name: Surgical / Clinical Planning Software ANVISA Registration Number: 80042070008 Hazard Class: III Brainlab Ltda; Brainlab AG Brazil
Name of the product: ANGIOGRAPHIC CATETER IMAGER II (SELECTIVE) Technical name: ANVISA registration number: 10341350453 Hazard class: IV Model affected: M001314141; M001314231; M001314321; M001314331; M001314351; M001314661; M001314671; M001315111; M001314111; M001314241; M001316871 Boston Scientific do Brasil Ltda; Teleflex Medical Brazil
Commercial Name: HMEF Cellulose Filter Technical Name: Electrostatic Filter with Heat Exchanger and Cellulose Moisture Exchanger ANVISA Registration Number: 80158680018 Hazard Class: II Model Affected: 4333 / 761PUBA Serial Number Affected: L5012678 GVS do Brasil Ltda; GVS do Brasil Ltda Brazil
CATETER UMBILICAL GMI Technical Name: CATETER UMBILICAL Registration Number ANVISA: 80423540023 Hazard Class: III Model Affected: 544-25 / 544-35 / 544-40 / 544-50 / 544-60 Gabisa Medical International LTDA EPP Brazil
Ureterorenofibroscope Technical Name: Ureterorenofibroscope Registration Number ANVISA: 80124630193 Hazard Class: II Model Affected: URF-P6 / P6R Series Affected: 2613119,2613237,2613239,2612933,2612936,2612947,2112H189,2613101, 2612937, 2613240, 2613102,2613844,2613861,2613846,2613847,2613848,2613845,2613864,2613866. Olympus Optical do Brasil Ltda.; Olympus Medical Systems Corp. Brazil
Trade name: Etest Cefuroxima Technical name: Etest family (Etest Cefuroxima): 100 strips (foam) and individual presentation 30 strips (single pack). ANVISA Registration Number: 10158120623 Hazard Class: II Model Affected: N / A Serial Numbers Affected: Reference 412305: Lot 1004497810 / Reference 506918: Lot 1004022170. Olympus Optical do Brasil Ltda.; Olympus Medical Systems Corp. Brazil
Trade name: ACCEL SYSTEM FOR COLLECTION OF BLOOD COMPONENTS Technical name: System for collection of blood components ANVISA registration number: 80554210015 Hazard class: III Affected model: ACCEL SYSTEM FOR COLLECTION OF BLOOD COMPONENTS Terumo BCT Tecnologia Médica Ltda.; Terumo BCT Inc. Brazil
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