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  • Dispositivo 2073
  • Fabricante 2073
  • Evento 2209
  • Implante 0
Nombre Clasificación Fabricante Nivel de riesgo País Fuente
XIO RTP system. Models at risk: version 5.51 and higher. Anvisa Registry n ° 80569320003. ELEKTA MEDICAL SYSTEMS COMÉRCIO E SERVIÇOS PARA RADIOTERAPIA LTDA.; IMPAC MEDICAL SYSTEMS INC Brazil ANVISA
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 ANVISA
Xpert BCR-ABL Monitor Technical Name: Chromosome Translocation BCR-ABL Registration Number ANVISA: 81062710016 Hazard Class: III Affected Model: Kit with 10 tests (cartridges with integrated reaction tubes) Serial numbers affected: LOT: 1000041807 CEPHEID BRASIL IMPORTAÇÃO, EXPORTAÇÃO E COMÉRCIO DE PRODUTOS DE DIGANÓSTICOS LTDA.; CEPHEID Brazil ANVISA
X-ray apparatus, Compact Plus, Risk class III, registration 10216710251, series / lots affected in annex. Philips Medical Systems Ltda.; Philips Medical Systems Ltda. Brazil ANVISA
X-ray Equipment (Miscellaneous) N/A Brazil ANVISA
X-ray Generator, X-ray Generator Set (1) Model KXO-50R, (2) Model KXO-50F, Model KXO-80N Toshiba America Medical Systems Inc Brazil ANVISA
X-ray Intraoral System, Model CS 2100 and CS 2200 (Former KODAK 2100 and KODAK 2200), Registration No. 80378750002. Serial numbers: WEYA056, WEYA057, WEYA058, WEYA059, WEYA278, WEYA279, WEYA280, WEYA281, WEYA282, WFYA330, WFYA331, WFYA332, XCYA027, XCYA028, XEYA411, XEYA459, XEYA460, XHYC033, XHYC034, XHYC035, XIYC357, XIYC358, XIYC359, XIYC360, XJYC061, XJYC062, XJYC063, XJYC064, XJYC065, XJYC066, XLYC082, XLYC083, XLYC084, XLYC085, YBYC163, YBYC165, YBYC165, YBYC166, YBYC292, YBYC293, YBYC294, YBYC295, YBYC296, YBYC297, YBYC298 CARESTREAM DO BRASIL COMERCIO E SERVIÇOS DE PRODUTOS MEDlCOS LTDA. Brazil ANVISA
X-ray Mobile Device X-ray Mobile Device Registration Number ANVISA: 80071260301 Hazard Class: III Model Affected: Brivo OEC 715, Brivo OEC 785, Brivo OEC 865 Affected serial numbers: • GE Brivo OEC715: Series numbers B2S15158 to B2S15164; B2S15166 to B2S15171; B2S15173 to B2S15195; B2S15197; B2S15200; B2S15202; B2S16046; B2S16050; B2S16051; • GE Brivo OEC785: Series numbers B3S15236; B3S15241; B3S15242; B3S15246; B3S15248; B3S15250; B3S15253 to B3S15257; B3S15259 to B3S15338; B3S15353; B3S15357 to B3S15359; B3S16152; • GE Brivo OEC865: Series numbers B4S15063 to B4S15070; B4S15072; B4S15073; B4S15075; B4S16029 GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE Hualun Medical Systems CO., LTD / GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda. Brazil ANVISA
X-ray System - 9800 Plus, GE Healthcare, registration 80071260009, model 9800 PLUS, hazard class III, all equipment GE Healthcare do Brasil Brazil ANVISA
X-ray System for Computed Tomography ,; Brand Philips; Risk class III; models:. . Brilliance, Registry: 10216710191; ///. . Ingenuity CT, Record: 10216710209; ///. Serial numbers: 31001/50215/95920/95921/95933/320113. Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc. Brazil ANVISA
X-ray System for Computed Tomography ,; Brand Philips; Risk class III; models:. . Brilliance, Registry: 10216710191; ///. . Ingenuity CT, Record: 10216710209; ///. Serial numbers: 58524531; 5,877,142; 61676906; 61701347; 61877637; 61965826; 6,213,815; 62218321; 62829796; 6,308,7087; 63090577; 6,374,4537; 63820666; 63842205; 63912144; 63929459; 64046882; 64075140; 62506739. Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc. Brazil ANVISA
X-ray System for Computed Tomography, Model MX 16-Slice, Registration nº 10216710193. Serial numbers: Attachment Philips Medical Systems Ltda.; Philips and Neusoft Medical Systems Co. LTD Brazil ANVISA
X-RAY SYSTEM FOR COMPUTERIZED TOMOGRAPHY. Anvisa Registry No. 10216710193. Affected units: EP16E100069, EP16E110084, EP16E110014, EP16E110044, EP16E110083, EP16E110012, EP16E110021, EP16E110008, EP16E110070, EP16EB110003, EP16EB110004, EP16EB110005 and EP16EB110006. Philips Medical Systems Ltda. Brazil ANVISA
X-RAY SYSTEM FOR COMPUTERIZED TOMOGRAPHY BRILLIANCE CT 64 (ANVISA Registry: 10216710191) and INGENUITY CT (Registro ANVISA: 10216710209). Software version 3.5.1. PHILIPS MEDICAL SYSTEMS LTDA Brazil ANVISA
X-ray System for Mevatron Therapy M, Registry 10234230021 - Serial Numbers: 3054; 3221; 3229; 3589; 3588; 3581; 3585; 3559; 3554; 5065; 5103; 5197; 5288; 5302; 5312; 5344; 5389; 5422; 5484; 5524; 5542; 5637; 5669; 5677; 5697; 5770; 5788; 5885; 2752; 3655; 3787; 3857; 3889; 3913; 3906; 3911; 3927; 3903; 70-4118; 70-4203; 2346; 2946; 2747; 2809; 2651; 2879; 2591. Siemens Ltda.; Siemens Medical Systems Brazil ANVISA
X-Ray System PROTEUS X / Ra, Hazard Class III, Model 600-0301, Registration: 80071260005, manufactured before January 2011 .. Serial numbers: 00000024890HL6; 00000024891HL4; 00000022726HL4; 00000025102HL5; 00000024837HL7; 00000025100HL9; 00000025105HL8; 00000024770HL0 and FMITR170990633 (distribution list attached) GE Healthcare do Brasil; GE HUALUN MEDICAL SYSTEMS CO., LTDA. Brazil ANVISA
X-ray Systems for Brilliance Computed Tomography. Anvisa Record: 10216710191. Potentially Affected Models: Brilliance 6, 10, 16, 16P, 40, 64, Big Bore, iCT, iCT SP. Philips Medical Systems Brazil ANVISA
X-RAY SYSTEMS FOR COMPUTERIZED TOMOGRAPHY, ANVISA Registry nº10216710191, INGENUITY CT, ANVISA Registry nº10216710209, COMPUTERIZED TOMOGRAPHY EQUIPMENT Mx8000 DUAL vEXP PHILIPS BRAND, ANVISA Registry nº10216710142. PHILIPS MEDICAL SYSTEMS LTDA. Brazil ANVISA
X-RAY SYSTEMS FOR COMPUTERIZED TOMOGRAPHY, registration 10216710191, models: Brilliance 16-slice (Ar); Brilliance CT 64; Brilliance CT Big Bore; and, registration 10216710209, models: Ingenuity Core; Ingenuity Core 128; Ingenuity Flex. Risk class III. Philips Medical Systems Ltda.; Philips Medical Systems Brazil ANVISA
Zilver Quick Change Stent, ZIVX5-125-7-3.0 models; ZIVX5-125-9-3.0; ZIVX5-125-8-3.0; ZIVX5-125-8-4.0, registration 10212990244, hazard class IV, Lots: C1001040; C1010612; C1145789; C980159; C1117285; C1139850; C910457; C991015; C1002635; C1009790. E. Tamussino & CIA.; COOK IRELAND LTDA, O HALLORAN ROAD, NATIONAL TECHNOLOGICAL PARK Brazil ANVISA
Zoll M Series Defibrillators. Paddles manufactured before September 1999; units distributed in the USA and internationally Zoll Medical Corp Brazil ANVISA
ZYM B / API NH / API LISTERIA - Anvisa Record nº 10158120560 / 10158120563/10158120563, respectively BIOMERIEUX S.A Brazil ANVISA
ZYM B, registration number 10158120560, hazard class I, lots: 1003765610, 1003772410, 1003772470, 1003787970, 1003790030, 1004077210, 1004097610, 1004355410, 1004355730. Biomerieux Brasil SA.; Biomérieux S.A. Brazil ANVISA
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