Events

Rappel de SIGNA PIONEER

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
    81008
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-08-23
  • 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
    The following issue is being addressed by ge healthcare file no. fmi 60903. images may exhibit novel artifacts on magic t2 flair synthetic reconstructions that may be difficult to recognize without access to conventional t2 flair weighted images. this issue has the potential to lead to misinterpretation of the magic images when making medical diagnosis or treatment decisions. magic acquisition is unique in that all contrasts are acquired simultaneously therefore any gross patient motion will impact all generated images and may further alter the presentation of the aforementioned novel artifacts. there have been no injuries reported as a result of this issue.

Device

SIGNA PIONEER

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)