International safety notice
Alert 2939 (Technosurveillance) GE Healthcare do Brasil X-ray System with Mobile Arm Possibility of failure of the Fluorostar 7900 board with consequent failure in the imaging functionality.
Brazil / Anvisa · BRA · Aug 14, 2019
Key facts
| Title | Alert 2939 (Technosurveillance) GE Healthcare do Brasil X-ray System with Mobile Arm Possibility of failure of the Fluorostar 7900 board with consequent failure in the imaging functionality. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Mobile Arm X-ray System Technical Name: Digital Radiography System ANVISA registration number: 80071260369 Risk Class: III Affected model: GE OEC Fluorostar Compact and GE OEC Fluorostar Series Affected serial numbers: FCDxxA18120681; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO GE HEALTHCARE DO BRASIL COM E SERV PARA EQUIPAMENTOS MÉDICOHOSPITALARES LTDA CNPJ 00029372000140 AV MAGALHÃES DE CASTRO Nº 4800 11º ANDAR CIDADE JARDIM SÃO PAULO SP TEL 3004 2525 CAPITAIS E REGIÕES METROPOLITANAS 0800 165 799 DEMAIS REGIÕES EMAIL TECNOVIGILANCIABRGECOM FABRICANTE DO PRODUTO GE OEC MEDICAL SYSTEMS GMBH WILHELMMAISELSTR 14 90530 WENDELSTEIN ALEMANHA |
| Models | 79-C5532D, FCDXXA18020425, FCDxxA18120681, 79-C4302D, 79-C8628D, 80071260369, FCDxxA18120684 |
| Date | Aug 14, 2019 |
| 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