Alerte De Sécurité sur Model 9800 Series Mobile C-Arm Fluoroscopic X-Ray Digital Imaging Systems. 9800 Series

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 OEC Medical Systems.

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
    230
  • Date
    2000-12-15
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    The x-ray systems mentioned require an upgrade to the -07 or 08 version of the system program. affected equipment indicates that the x-ray is being produced when operators take their foot off the pedal, however, the x-ray is not being produced and the indicator light and beep work incorrectly. the described x-ray systems were considered defective according to 21 cfr 1003.10. the manufacturer initiated a correction by registered letter dated april 21, 2000. the fda approved the company's corrective action plan on october 26, 2000.
  • Action
    Make sure you have received the correspondence sent on April 21, 2000, by GE OEC Medical Systems. Identify and collect any affected product from your inventory. For more information, contact your local representative or directly with GE OEC Medical Systems at (801) 328-9300 in the United States.

Manufacturer

  • Source
    ANVSANVISA