Events

Rappel de GE Lightspeed CT Scanners with MDAS 16 5V power supply

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
    18950
  • Date de mise en oeuvre de l'événement
    2015-08-03
  • 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
    Ge healthcare has become aware that the service procedure used to replace a power supply on the rotating side of the gantry specifies the wrong torque for the mounting hardware. because of this error, the three mounting bolts securing the power supply could have been over-torqued when the component was replaced since installation. in the unlikely event that the component becomes loose on the ct gantry during operation, it could result in serious bodily injury if the component were to be expelled.
  • Action
    Manufacturer to issue advice regarding use

Device

GE Lightspeed CT Scanners with MDAS 16 5V power supply
  • Modèle / numéro de série
    Model: LightSpeed Ultra, LightSpeed Plus, LightSpeed QX/i, LightSpeed 16, Affected: Manufactured from 2003-2006
  • Manufacturer
    GE Medical Systems LLC

Manufacturer

GE Medical Systems LLC