Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE Healhcare OEC Medical Systems; GE Healthcare do Brasil Comércio e Serviços para Equipamentos Médico-Hospitalares Ltda.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    916
  • Date
    2008-05-08
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    For more information, contact the Customer Service Center on 0800 122 345.
  • Reason
    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.
  • Action
    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.

Device

Anvisa nº 80071260008, series 79 - C1841 and 79-C1903, manufactured by GE Healhcare OEC Medical S...

Manufacturer

GE Healhcare OEC Medical Systems; GE Healthcare do Brasil Comércio e Serviços para Equipamentos M...