Events

Rappel de SIGNA HDE 1.5T MRI SYSTEM - 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
    140464
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-12-26
  • 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
    Magnet rundown unit (mru) may not be connected to the magnet. if the mru is disconnected the mru will not function as expected and will not quench the magnet when the button is pressed. in emergency situations a disconnected mru could delay removal of a ferrous object from the magnet potentially resulting in life-threatening injuries. the mru must be connected to the magnet at all times.

Device

SIGNA HDE 1.5T MRI SYSTEM - MAIN UNIT
  • Modèle / numéro de série
    Model Catalog: S7505KY (Lot serial: 604202MR); Model Catalog: S7505KY (Lot serial: 604520MR2); Model Catalog: S7505KY (Lot serial: 514747MRI); Model Catalog: S7505KY (Lot serial: 604941MRI); Model Catalog: S7505KY (Lot serial: 450688MR); Model Catalog: S7505KY (Lot serial: 514341MRI); Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 613737MR1); Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 506648MR4); Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 403229MR1); Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 416249MR2)
  • Description du dispositif
    Signa HDE 1.5T MRI System
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)