Events

Rappel de DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING 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
    25331
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2015-08-31
  • 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 predicted head sar value from the modeling when using ge healthcare 3.0t mr scanners with the whole body rf transmit coil and receive-only surface coils for head and/or neck imaging suggests that actual sar delivered to the head could potentially exceed the 3.2 w/kg sar limit defined in iec60601-2-33. this issue does not affect mr scans performed outside the head and neck areas.

Device

DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING SYSTEM - MAIN UNIT
  • Modèle / numéro de série
    Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 00000000UA0010); Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 663); Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 00000000UA0364); Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 00000000UA0042); Model Catalog: M3335JJ (Lot serial: 00000279069MR9); Model Catalog: M3335JJ (Lot serial: 00000HDMR10727); Model Catalog: M7000BD (Lot serial: 00000291154MR3); Model Catalog: M7000BD (Lot serial: 00000303327MR1); Model Catalog: M7000BD (Lot serial: 00000300711MR9); Model Catalog: M7000BD (Lot serial: 00000298951MR5); Model Catalog: M7000BD (Lot serial: 000000000R2726); Model Catalog: M7000BD (Lot serial: 00000296265MR2); Model Catalog: M7000BD (Lot serial: 00000299547MR0); Model Catalog: M7000BD (Lot serial: 00000291008MR1); Model Catalog: M7000BD (Lot serial: 00000296200MR9); Model Catalog: M7000BD (Lot serial: 00000300563MR4)
  • Description du dispositif
    DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)