International safety notice
Angiography Equipment - OPTIMA CARDIOVASCULAR IMAGING SYSTEM
Brazil / Anvisa · BRA · Nov 23, 2015
Key facts
| Title | Angiography Equipment - OPTIMA CARDIOVASCULAR IMAGING SYSTEM |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | OPTIMA CARDIOVASCULAR IMAGING SYSTEM, models CL323 and IGS320, risk class III, registration 80071260314. Serial number: see attached letter. |
| Manufacturer | DETENTOR DO REGISTRO GE HEALTHCARE DO BRASIL CNPJ 00 029 372 0001 40 ENDEREÇO AV MAGALHÃES DE CASTRO Nº 4800 13º ANDAR CIDADE JARDIM SÃO PAULO FABRICANTE GE HUALUN MEDICAL SYSTEMS CO LTD ENDEREÇO NO 1 NORTH YONG CHANG STREET BEIJING ECONOMIC TECHNOLOGICAL DEVELOPMENT ZONE P CHINA |
| Models | 80071260314, CL323, IGS320 |
| Date | Nov 23, 2015 |
| 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