Events

Alerte De Sécurité sur 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.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par GE Healhcare OEC Medical Systems; GE Healthcare do Brasil Comércio e Serviços para Equipamentos Médico-Hospitalares Ltda.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    916
  • Date
    2008-05-08
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    For more information, contact the Customer Service Center on 0800 122 345.
  • Cause
    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...