Events

Rappel de GE Infinia Nuclear Medicine 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 Functional Imaging Haifa.

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
    16182
  • Date de mise en oeuvre de l'événement
    2014-02-11
  • 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
    A potential life-threatening hazardous situation may occur if there is unintended radial detector motion leading to patient contact. this failure mode has been observed on a single system for a whole body scan, in which the detector moved to the home position and then slowly started drifting inward toward the patient. this generated both a visual and audio alert condition on both the console and the gantry. no injuries have been reported to date.
  • Action
    Product to be modified

Device

GE Infinia Nuclear Medicine Systems

Manufacturer

GE Medical Systems Functional Imaging Haifa