Events

Rappel de GE Magnetic Resonance 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 LLC.

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
    16485
  • Date de mise en oeuvre de l'événement
    2014-04-03
  • 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
    Gradient coil electromechanical connections may loosen causing an increase in resistance. the increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the rear endbell enclosure to overheat, generate smoke in the scan room, and cause some localized melting of the endbell. this overheating has occurred only while units were being serviced by ge service engineers during repeated evaluation scanning. however, the issue could also occur in clinical mode.
  • Action
    Product to be modified

Device

GE Magnetic Resonance Imaging Systems
  • Modèle / numéro de série
    Model: Models: : Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products, Affected:
  • Manufacturer
    GE Medical Systems LLC

Manufacturer

GE Medical Systems LLC