International safety notice
Optima X-ray System
Brazil / Anvisa · BRA · Jan 5, 2015
Key facts
| Title | Optima X-ray System |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Optima X-ray System ANVISA registration number: 80071260245 Risk class: III Model(s) affected; The Optima XR200amx and BRIVO XR285amx X-Ray systems (ANVISA Registration 80071260246) are also affected. |
| Manufacturer | NOME DA EMPRESA FABRICANTE GE MEDICAL SYSTEMS LLC PAÍS ESTADOS UNIDOS ENDEREÇO 3000 GRANDVIEW BLDV WAUKESHA WI 53188 DETENTOR DO REGISTRO GE HEALTHCARE DO BRASIL ENDEREÇO AV MARGALHÃES DE CASTRO Nº 4800 13ºANDAR CIDADE JARDIM |
| Models | 80071260245, XR285amx, XR200amx, XR220AMX, 80071260246 |
| Date | Jan 5, 2015 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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