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.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GE Healhcare OEC Medical Systems; GE Healthcare do Brasil Comércio e Serviços para Equipamentos Médico-Hospitalares Ltda.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    916
  • Fecha
    2008-05-08
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    For more information, contact the Customer Service Center on 0800 122 345.
  • Causa
    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.
  • Acción
    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.