Events

Rappel de SIGNA EXCITE 3.OT G3 MAGNET

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
    155050
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-09-30
  • 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 for failure for users to provide an obstacle free service path outside the 200g field & not having another trained person on site resulting in death or serious injury to service engineers.

Device

SIGNA EXCITE 3.OT G3 MAGNET
  • Modèle / numéro de série
    Model Catalog: M3333TD (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M1800MA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M1060YW (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M1060LG (Lot serial: ALL SERIAL NUMBERS); Model Catalog: DISCOVERY MR450 1.5T MR SYSTEM (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M3335JK (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M1000RA/RD/RF/RG (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M7000MC (Lot serial: ALL SERIAL NUMBERS); Model Catalog: S7504HP (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M7000MA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M1000MA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M3335JG (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M3335J (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M3335JA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M3000TD (Lot serial: ALL SERIAL NUMBERS)
  • Description du dispositif
    SIGNA EXCITE 3.OT G3 MAGNET
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)