Events

Rappel de 1.5T SIGNA HDX MR 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
    32599
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-04-25
  • 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 screen save images are included in a wrong exam due to duplicate uid (unique identifier) creation. this may cause a safety issue due to a potential patient data mismatch.This issue occurs when all of the following criteria are met: performed procedure step (pps) is enabledtwo screen save series generated on study instanceuid starting with 1.X and 2.X respectively with pps status set as "defer" for both if these series are transferred to a cpsi pacs both of them would show up under the same patient study instanceuid starting with 1.X.

Device

1.5T SIGNA HDX MR SYSTEM - MAIN UNIT
  • Modèle / numéro de série
    Model Catalog: M3335J (Lot serial: ); Model Catalog: M3335JA (Lot serial: ); Model Catalog: M3335JB (Lot serial: ); Model Catalog: M3335JG (Lot serial: ); Model Catalog: M3000TD (Lot serial: ); Model Catalog: M3335AG (Lot serial: ); Model Catalog: M3335JK (Lot serial: ); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: ); Model Catalog: M1060LG (Lot serial: ALL); Model Catalog: M3000CB (Lot serial: )
  • Description du dispositif
    1.5T Signa HDX MR System
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)