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Nombre Clasificación Fabricante Nivel de riesgo País Fuente
Trade name: Uphold Vaginal Support. Technical Name: Screens. ANVISA registration number: 10341350701. Class of risk: III. Model Affected: M0068317080. Capio Suture Capture Device. Technical Name: Suture Gripper. ANVISA registration number: 10341350717. Class of risk: II. Model Affected: M0068311251. Capio ™ SLIM - Suture Capture Device. Technical Name: Suture Gripper. ANVISA registration number: 10341350777. Risk class: II. Model Affected: M0068318250. Uphold Lite with Capio SLIM - Vaginal Support System. Technical Name: Screen. ANVISA registration number: 10341350779. Risk class: III. Affected Model: M0068318170 Boston Scientific do Brasil Ltda; Medventure Technology Corporation Brazil ANVISA
Commercial Name: Patient Ceiling Elevators. Technical Name: Movement / Patient Transfer Device. ANVISA Registration Number: 80259110133. Hazard Class: I. Model Affected: Maxi Sky 2. Serial Number Affected: 300174590 Maquet do Brasil Equipamentos Medicos Ltda; ARJOHUNTLEIGH AB Brazil ANVISA
Trade name: Atrial catheter. Technical Name: Catheters. ANVISA registration number: 10166360031. Risk class: IV. Model affected: AC, AE, AH. Serial number affected :. Code AC: lot 06 series 01 to 10, lot 07 series 01 to 10. Code AE: lots 17 to 29 series 01 to 10. Code AH: lot 04 series 01 to 10 HP Bioproteses Ltda. Brazil ANVISA
Commercial Name: Ultrasound System. Technical Name: Ultrasound Device. ANVISA registration number: 80372200002. Hazard class: II. Model affected: MyLab70 XVG; MyLab60; MyLab70 X Vision. Serial numbers affected: 4263; 4798; 5198; 5205; 5321; 5379; 5476; 5880; 5880; 5923; 6412 Anima Médica Comércio Importação e Exportação Ltda; Esaote S.p.A. Brazil ANVISA
Trade name: Centricity Pacs IW. Technical Name: Software. ANVISA registration number: 80071260309. Risk class: II. Affected Model: Centricity Pacs IW With Universal Viewer | Centricity Universal Viewer. Serial Number Affected: Centricity Pacs IW With Universal Viewer | Centricity Universal Viewer (80071260309) GE Healthcare do Brasil, Com; GE Healthcare Brazil ANVISA
Trade name: ADVIA Centaur Cyclosporin (CsA); ADVIA Centaur DHEA-SO4 (DHEAS); ADVIA CENTAUR FOL; ADVIA CENTAUR HBc IgM-. Technical Name: Ciclosporin; Dehydroepiandrosterone Sulfate (Dhea-S); Folate. Nuclear Immunoglobulin M for Hepatitis B Virus. ANVISA registration number: 10345161772; 10345161738; 10345160571; 10345160594. Class of risk: III; II; II; IV. Model Affected: N / A. Serial number affected: See distribution map Siemens Healthcare Diagnósticos Ltda; Siemens Healthcare Diagnostics Inc. Brazil ANVISA
Commercial Name: Ultrasound System. Technical Name: Ultrasound Device. ANVISA registration number: 80372200002. Hazard class: II. Model affected: MyLab70 XVG; MyLab60; MyLab70 X Vision. Serial numbers affected: 1093; 1096; 1103; 1106; 1135; 1171; 1189; 1191; 1193; 1209; 1212; 1223; 1224; 1225; 1251; 1254; 1255; 1258; 1259; 1260; 1263; 1264; 1265; 1266; 1267; 1268; 1271; 1274; 1275; 1276; 1353; 1436; 1437; 1442; 1443; 1463; 1466; 1471; 1472; 1493; 1498; 1499; 1506; 1520; 1521; 1522; 1523; 1524; 1528; 1529; 153/01370; 153/01373; 153/01383; 1531; 1532; 1533; 1537; 1538; 1544; 1545; 1546; 1547; 1548; 1621; 1622; 1630; 1631; 1632; 1801; 1802; 1803; 1804; 1805; 1837; 1838; 1839; 1870; 1871; 1872; 2075; 2077; 2137; 2138; 2147; 860; 984; 985; 988; 991; 1341; 1512; 1582; 1588; 1604; 1605; 1757; 1783; 1791; 1824; 1830; 1985; 2096 Anima Médica Comércio Importação e Exportação Ltda; Esaote S.p.A. Brazil ANVISA
Commercial Name: Ultrasound System. Technical Name: Ultrasound Device. ANVISA registration number: 80372200002. Hazard class: II. Model affected: MyLab70 XVG; MyLab60; MyLab70 X Vision. Name: Anesthesia System Carestation. Technical Name: Pulmonary Ventilator. ANVISA registration number: 80071260334. Class of risk: III. Affected Model: Carescape R860. Serial numbers affected: See attached list GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; Datex-Ohmeda Inc. Brazil ANVISA
Commercial name: SUROS TriMark Site Identification Device. Technical name: SUROS, TRIMARK LOCAL IDENTIFICATION DEVICE. ANVISA registration number: 80047300529. Risk class: III. Model affected: TRIMARK TD 13-09; TRIMARK TD 13-12; TRIMARK TD 13-MR; TRIMARK TD 36-09; TRIMARK TD 36-12 .. Serial number affected: TRIMARK TD 1309 lots 17K05RF. TRIMARK TD 1312 batches: 16L08RN, 16K24RM, 17A13RL, 17C10RC, 17D17RA, 17H07RA, 17J08RH. TRIMARK TD 13MR batches: 17C02RF, 17C24RB, 17D17RB. TRIMARK TD 3609 batches: 16K20RA, 16K25RK, 17A10RB, 17B02RF, 17C10RD, 17G31RA, 17D24RD, 17F19R, 17G05RA, 17G31RA, 17H14RA, 17K05RB, 17L01RB Medstar Importação e Exportação Ltda; HOLOGIC INC. Brazil ANVISA
Trade name: Uphold Vaginal Support. Technical Name: Screens. ANVISA registration number: 10341350701. Class of risk: III. Model Affected: M0068317080. . Capio Suture Capture Device. Technical Name: Suture Gripper. ANVISA registration number: 10341350717. Class of risk: II. Model Affected: M0068311251. . Capio ™ SLIM - Suture Capture Device. Technical Name: Suture Gripper. ANVISA registration number: 10341350777. Risk class: II. Model Affected: M0068318250. . Uphold Lite with Capio SLIM - Vaginal Support System. Technical Name: Screen. ANVISA registration number: 10341350779. Risk class: III. Affected Model: M0068318170 Boston Scientific do Brasil Ltda; Medventure Technology Corporation Brazil ANVISA
Trade name: Exactrac Location System. Technical Name: Stereotaxic System. ANVISA registration number: 80042070004. Class of risk: III. Affected Model:. Serial number affected: 8596415001; 202616001; 202616001 Brainlab Ltda; Brainlab AG Brazil ANVISA
Commercial Name: Getinge 88 Turbo Washer-Disinfector. Technical Name: Instrument for Cleaning and Disinfection of Instruments. ANVISA registration number: 80259110098. Class of risk: II. Model affected: model 88-5. Serial number affected: WAA056378; WAA057396 Maquet do Brasil Equipamentos Médicos Ltda; Getinge Disinfection AB Brazil ANVISA
Trade name: Taylor Enteral Feeding Probe. Technical Name: Probe. ANVISA registration number: 10229650021. Risk class: II. Affected Model: number 12. Serial Number Affected: Lot: RM2897 Cirúrgica Brasil Comercial e Importadora Ltda; Cirúrgica Brasil Comercial e Importadora Ltda. Brazil ANVISA
Trade name: HeartStart FRx. Technical Name: Defibrillator. ANVISA registration number: 10216710172. Class of risk: III. Affected Model:. Serial number affected: See attached list Philips Medical Systems Ltda Brazil ANVISA
Trade name: Etest family. Technical Name: Microorganism Identification / Antibiogram Device. ANVISA registration number: 10158120623. Class of risk: II. Affected model: Etest Polymyxin B. Serial number affected: 1002446640; 1002559300; 1002639240; 1002735070; 1002797130; 1003187220; 1003230410; 1003288010; 1003538020; 1003655420; 1003957060; 1004164300; 1004193060; 1004296350; 1004348480; 10044414690; 1004773920; 1004951670; 1005020680; 1005161530; 1005325780; 1005329410; 1005497750; 1005558710; 1005753830; 1005945380; 1002280140; 1002431510; 1002605340; 1002762220; 1002797270; 1003006080; 1003230380; 1003322180; 1003553910; 1003655460; 1003719640; 1004164310; 1004347610; 1004370570; 1004530070; 1004767110; 1004838770; 1004955950; 1005020690; 1005329420; 1005536040; 1005659460; 1005716410; 1005851010 bioMerieux Brasil Ind e Com de Prod Laboratoriais Ltda; Biomerieux S.A Brazil ANVISA
Trade name: Minimed 640G Insulin Pump. Technical Name: Infusion Pump. ANVISA registration number: 10339190656. Class of risk: III. Affected Model: MMT-1712K; MMT-1752; MMT-1752K; MMT-1752KBP; MMT-1752WWK; MMT-1752WWKA. Serial number affected: See distribution map Medtronic Comercial Ltda; Medtronic Puerto Rico Operations Co. Brazil ANVISA
Trade name: Team Volumat Agilia VL ON70. Technical Name: Equipment. ANVISA registration number: 80145110199. Risk class: III. Affected Model: VL ON 70. Serial Number Affected: 32342397 Fresenius Kabi Brasil Ltda; Clinico Medical Sp.Z. Brazil ANVISA
Trade name: Family E-Check- Sysmex (Xn Check). Technical name: Combined parameters in the same product. ANVISA registration number: 80015490061. Class of risk: II. Affected Model: 12 Vials X3.0 Ml of Each Level (Level 1, Level 2, Level 3). Serial number affected: 7320, 8011, 8067 Sysmex Do Brasil Indústria E Comércio Ltda; Sysmex Corporation Brazil ANVISA
Trade name: Ingenuity CT. Technical name: CT Scanner. ANVISA registration number: 10216710209. Risk class: III. Model Affected: Ingenuity CT / Ingenuity Flex. Serial number affected: 200210, 52066, 310362, 310375, 338003, 336213, 52073, 30035, 345218, 52062, 32045. Philips Medical Systems Ltda; Philips Medical Systems (Cleveland), Inc Brazil ANVISA
Trade name: SOMATOM Computerized Tomography System. Technical name: CT Scanner. . Model: SOMATOM Emotion Registration No .: 10345161972, Risk Class: III; Model: SOMATOM Spirit; Risk Class: III; Registration No: 10345162002 Hazard Class: III. Model: SOMATOM Scope Power, Registration No: 10345161975, Risk Class III :. Model: SOMATOM Perspective, Registration Number: 10345162001, Hazard Class: III Siemens Healthcare Diagnósticos Ltda; Siemens Healthcare GmbH Brazil ANVISA
Commercial name: cobas b 221 <6> equipped with AutoQC module. Technical name: Instrument for analysis of blood gases, ions or pH. ANVISA registration number: 10287410226. Class of risk: II. Affected model: cobas b 221 <6> equipped with AutoQC Module. Serial number affected: see Distribution map Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH Brazil ANVISA
Trade name: FS-14 Double Pedal component of the HF-120 / SS 200-E models. Technical name: Microprocessed Electronic Scalpel. ANVISA registration number: 10247670035. Risk class: III. Model affected: HF-120 / SS 200-E. Serial number affected: 8020140101; 8020950101; 8025670101; 8003380101; 8017000101; 8003040101 WEM Equipamentos Eletronicos Ltda Brazil ANVISA
Trade name: Darco Locking Screws. Technical name: Non-bioabsorbable, non-sterile orthopedic bone screw. ANVISA registration number: 80491360021. Risk class: III. Model Affected: DC2820014; DC2820016; DC2820018; DC2820020; DC2820024; DC2820026; DC2820028; DC2820030; DC2820035; DC2820040; DC2820045; DCS2820016; DCS2820018; DCS2820020; DCS2820022; DCS2820024; DCS2820026; DCS2820035 .. Serial number affected: 1585745; 1588776; 1585008; 1585009; 1585746; 1582378; 1583096; 1587743; 1587953; 1582607; 1584564; 1588017; 1585615; 1585879; 1584081; 1584357; 1584518; 1588840; 1589004; 1585460; 1587620; 1583921; 1584308; 1589175; 1587622; 1585079; 1583922; 1585806; 1588312; 1588217; 1583273; 1585289; 1583013; 1588452; 1585384; 1585877; 1583014; 1587426; 1585162; 1589284; 1584734; 1588548; 1583369; 1583923; 1584939; 1583274; 1585804; 1589286; 1578340; 1585078; 1588016; 1584733; 1582608; 1588216; 1583094; 1583370; 1585613; 1584517; 1587621; 1585878; 1583093; 1583095; 1583371; 1587623; 1585747; 1583924; 1585383; 1587688; 1583092. Wright Medical Brasil Ltda Me; Wright Medical Technology, Inc. Brazil ANVISA
Trade name: Infinity M540. Technical Name: Monitor. ANVISA registration number: 10407370126. Class of risk: III. Model affected: n / a. Serial number affected: See distribution map Dräger Indústria e Comércio Ltda; Dräger Medical System Inc. Brazil ANVISA
Commercial Name: Needle for aspiration of sternal-iliac bone marrow illinois. Technical Name: Needle for Biopsy. ANVISA registration number: 80102510723. Risk class: II. Model Affected: TIN3018. Serial number affected: 841212 VR Medical importadora e distribuidora de produtos médicos Ltda.; Carefusion Brazil ANVISA