International safety notice
Alert 2574 (Technosurveillance) - GE Healthcare do Brasil - Computed Tomography System / Computed Tomography Equipment Possibility of electric shock during internal maintenance activities on the equipment.
Brazil / Anvisa · BRA · May 25, 2018
Key facts
| Title | Alert 2574 (Technosurveillance) - GE Healthcare do Brasil - Computed Tomography System / Computed Tomography Equipment Possibility of electric shock during internal maintenance activities on the equipment. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Computed Tomography System / Computed Tomography Equipment Technical Name: Computed Tomography Equipment ANVISA registration number: 80071260079 Risk Class: III Modelo afetado: Optima CT 540, BRIGHTSPEED ELITE 16 SLICE EDITION, Optima CT 540 Mobile, OPTIMA CT 660, REVOLUTION EVO, Optima CT 660 Cj 3.5 (80071260119 e 80071260079) Affected serial numbers: CJRAX1600072CN; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO GE HEALTHCARE DO BRASIL COM E SERV PARA EQUIPAMENTOS MÉDICOHOSPITALARES LTDA CNPJ 00 029 372 0001 40 AV MAGALHÃES DE CASTRO Nº 4800 13º ANDAR CIDADE JARDIM SÃO PAULO SP TEL 11 30678436 EMAIL PATRICIASANTANAGECOM FABRICANTE DO PRODUTO GE HEALTHCARE JAPAN CORPORATION PAIS JAPÃO ENDEREÇO 7127 ASAHIGAOKA 4CHOME HINOSHI 1918503 TÓQUIO JAPÃO GE HEALTHCARE DO BRASIL COM E SERV P EQUIP MÉDICOHOSPITALARES LTDA PAIS BRASIL ENDEREÇO AV VEREADOR JOAQUIM COSTA 1405 LINDA VISTA CONTAGEM MG GALPÃO 7 CAMPINA VERDE CEP 32150240 GE MEDICAL SYSTEMS LLC PAIS USA ENDEREÇO 3000 GRANDVIEW BLDV WAUKESHA WI 53188 EUA GE HANGWEI MEDICAL SYSTEMS CO LTD PAIS CHINA ENDEREÇO WEST AREA OF BUILDING NO3 NO1 YONGCHANG NORTH ROAD BEIJING ECONOMIC AND TECHNOLOGICAL DEVELOPMENT AREA BEIJING 100176 CHINA |
| Models | 80071260119, CJRAX1700002CN, 00000441968CN5, CBAQG1600010HM, 00000033404YC5, 00000429530CN9, 00000429355CN1, 80071260079, JRMX1600011CN, 00000035290YC6, CJRMX1600014CN, CJRMX1600012CN and 13 more |
| Date | May 25, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1