International safety notice
Computed Tomography System
Brazil / Anvisa · BRA · Feb 19, 2016
Key facts
| Title | Computed Tomography System |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Lightspeed Computed Tomography System ANVISA registration number: 80071260076 Risk class: III Model(s) affected; 00000327271CN3 (São Paulo-SP); 00000346702CN4 (Goiânia-GO); 00000002103PT0 (Ribeirão Preto-SP); 00000003306PT8 (São Paulo-SP); 00000310682CN0 (Porto Alegre-RS); 00001002103YM8 (Santana-RS); 00000004411PT5 (Goiânia-GO); 00000004411PT5 (São Paulo-SP); 00000003310PT0 (São Paulo-SP); 00000383739CN0 (Pouso Alegre-MG); The following CT scanners are affected by this field action: - LightSpeed Ultra (8-cut MDAS), LightSpeed Plus (4-cut MDAS), LightSpeed QX/i (4-cut MDAS) and LightSpeed 16 (MDAS only). The following PET CT scanners are affected by this field action: - Discovery ST e Discovery LS. |
| Manufacturer | NOME DA EMPRESA FABRICANTE GE HANGWEI MEDICAL SYSTEMS CO LTD PAÍS CHINA ENDEREÇO NO 1 2 NORTH YONG CHANG STREET BEIJING ECONOMIC TECHNOLOGICAL DEVELOPMENT PR BEIJING |
| Models | 80071260076, 00000383739CN0, 00000346702CN4, 00000003306PT8, 00000327271CN3, 00000004411PT5, 00000310682CN0, 00000003310PT0, 00001002103YM8, 00000002103PT0 |
| Date | Feb 19, 2016 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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