International safety notice
Technical name: Computed Tomography Equipment
Brazil / Anvisa · BRA · May 26, 2017
Key facts
| Title | Technical name: Computed Tomography Equipment |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: Computed Tomography Equipment Technical name: Computed Tomography Equipment ANVISA registration number: 80071260079 Risk class: III Affected model: Optima CT 540 Affected serial numbers: BrightSpeed Select (ANVISA Registration 80071260096) Optima CT 540 (Registration ANVISA 80071260079) Optima CT 580, Discovery RT (ANVISA Registration 80071260129) Optima CT660, Revolution EVO (ANVISA Registration 80071260119) Discovery CT590RT (ANVISA Registration 80071260132) LightSpeed VCT (Re ANVISA registration 80071260076) LightSpeed RT16 (ANVISA Registration 80071260091) Discovery PET/CT 600, 690 (ANVISA Registration 80071260109) Discovery PET/CT 610, Discovery PET/CT 710 (ANVISA Registration 80071260295) Discovery IQ (ANVISA Registration 80071260344); |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO GE HEALTHCARE DO BRASIL COM E SERV PARA EQUIPAMENTOS MÉDICOHOSPITALARES LTDA AV MAGALHÃES DE CASTRO Nº 4800 11º ANDAR CIDADE JARDIM SP FABRICANTE GE HANGWEI MEDICAL SYSTEMS CO LTD WEST AREA OF BUILDING NO3 NO1 YONGCHANG NORTH ROAD BEIJING ECONOMIC AND TECHNOLOGICAL DEVELOPMENT AREA BEIJING 100176 CHINA |
| Models | CT560, CT660, 80071260091, 80071260295, 80071260119, 80071260096, CT670, 80071260079, CT590RT, 80071260109, 80071260130, 80071260354 and 4 more |
| Date | May 26, 2017 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
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