Alerta De Seguridad para Anvisa nº 80071260008, series 79 - C1841 and 79-C1903, manufactured by GE Healhcare OEC Medical Systems in Germany and marketed in Brazil by GE Healthcare do Brasil Trade and Services for Medical- Hospitalares Ltda.

Safety alert

916

2008-05-08

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

The system design may compromise the first barrier located at the rear of the camera, causing unexpected exposure of the operator and / or his or her personnel within the radius of the equipment. this problem may even cause the system to initial non-conformance according to the provision for radiation leakage barrier (21 cfr 1020.32 (a).) ge informs that this radiation exposure has minimal impact, operator, team or patient and that it can not cause any major radioactive damage. the manufacturer issued an electronic product radiation warning letter, available at the link: http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2008/ alerta_916_carta.Pdf the alert published by ecri, translated into portuguese, is available at http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2008/alerta_916_traduz.Pdf.

Identify any affected products in your inventory and verify that you received the Electronic Product Radiation Warning Letter dated February 14, 2008. GE does not recommend that affected devices be removed from the service. GE is working on a solution to the problem. As soon as the solution is made available, the GE representative will contact your customers for free assistance.