Events

Rappel de REVOLUTION CT - MAIN UNIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    74232
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-04-19
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Ge healthcare has become aware that an out of tolerance torque tool was used on three joints on revolution ct system during the manufacturing process. if the x-ray tube becomes loose on the ct gantry during operation this could result in beam tracking errors potential scan aborts and/or a possible image artifact. there is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail. there have been no injuries reported as a result of this issue.

Device

REVOLUTION CT - MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)