Events

Rappel de HAWKEYE

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
    130588
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2008-05-30
  • 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
    Possibility of misregistration in brain scan that are performed in hybrid infinia with hawkeye option (hawkeye 1 or hawkeye 4) which could result in misdiagnosis and result in improper treatment.

Device

HAWKEYE
  • Modèle / numéro de série
    Model Catalog: H3000YM (Lot serial: MANUFACTURER); Model Catalog: H3000YM (Lot serial: >10 NUMBERS); Model Catalog: H3000WZ (Lot serial: MANUFACTURER); Model Catalog: H3000WW (Lot serial: MANUFACTURER); Model Catalog: H3000YM (Lot serial: CONTACT); Model Catalog: H3000WZ (Lot serial: >10 NUMBERS); Model Catalog: H3000WW (Lot serial: CONTACT); Model Catalog: H3000WC/WD (Lot serial: MANUFACTURER); Model Catalog: H3000WC/WD (Lot serial: CONTACT); Model Catalog: H3000WC/WD (Lot serial: >10NUMBERS); Model Catalog: H3000WW (Lot serial: >10 NUMBERS); Model Catalog: H3000WZ (Lot serial: CONTACT); Model Catalog: H2508RB (Lot serial: H2508RB 108303); Model Catalog: H2508RB (Lot serial: 108308-1 517671 108305); Model Catalog: H2508RA (Lot serial: H2508RB 108303); Model Catalog: H2508RA (Lot serial: 108308-1 517671 108305)
  • Description du dispositif
    HAWKEYE
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)