Events

Rappel de IMAGE PASTING PATIENT BARRIER

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
    132271
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-10-19
  • 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 of a potential issue associated with the patient barrier rotating arm that is a part of the definium 8000 and discovery xr650 image pasting systems that may impact patient and/or user safety. the patient barrier rotating arms that are used to position and stabilize the patient during image pasting procedures may fail to retain residual friction at the arm pivot. this could permit the arm to swing freely when the rotating arm locking lever is released. should this happen during use injury to the patient and/or user could occur.

Device

IMAGE PASTING PATIENT BARRIER

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)