Events

Rappel de MR SURGICAL SUITE II TABLE

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
    44985
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-10-29
  • 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
    Potential safety issue with the table transfer release of the mr surgical suite ii mr system. the issue may cause an unexpected function loss of the patient transfer mechanism that allows the patient to be moved between the mr and surgical tables. this could delay care and handling of a patient during surgical or interventional procedures. ge has received one complaint of a transfer board not releasing from the mr table preventing the transfer board from moving to the surgical table. there have been no injuries reported as a result of this issue.

Device

MR SURGICAL SUITE II TABLE

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)