Events

Rappel de GE FlexiView 8800 Mobile C-Arm Mobile Imaging Systems

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par GE Medical Systems (India) Private Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    13732
  • Date de mise en oeuvre de l'événement
    2012-10-31
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 recall data from the U.S. and New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Cause
    The manufacturer advises that the system may lock-up during system usage; the system may stall during the boot cycle; when the image directory is accessed and thumbnail images are used to recall patient images, incorrect images may be displayed or there may be an inability to locate images on the system; failure of the system to display the international standard quantity, air kerma, to describe the radiation output.
  • Action
    Software to be upgraded

Device

GE FlexiView 8800 Mobile C-Arm Mobile Imaging Systems

Manufacturer

GE Medical Systems (India) Private Ltd