Events

Rappel de XELERIS NUCLEAR MEDICINE WORKSTATION

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
    73289
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-12-15
  • 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
    1.Erroneous measurements on ct images identified 2.Possibility of getting wrong standardized uptake values (suv) 3.Software issue in brain spect application may switch between display of early and late images of dual scan studies.

Device

XELERIS NUCLEAR MEDICINE WORKSTATION
  • Modèle / numéro de série
    Model Catalog: H3700JA/JB/KA/KB (Lot serial: CONTACT); Model Catalog: H3700JA/JB/KA/KB (Lot serial: >100 NUMBERS); Model Catalog: H3700JA/JB/KA/KB (Lot serial: MANUFACTURER); Model Catalog: XELERIS 3 (Lot serial: S/N'S 0000CZC94154WH002); Model Catalog: XELERIS 3 (Lot serial: 0000CZC94158R3000); Model Catalog: S8006KA/KB/KC/KD (Lot serial: MANUFACTURER); Model Catalog: H3900NM (Lot serial: MANUFACTURER); Model Catalog: H3900JH (Lot serial: MANUFACTURER); Model Catalog: S8006KA/KB/KC/KD (Lot serial: >100 NUMBERS); Model Catalog: H3900NM (Lot serial: CONTACT); Model Catalog: H3900JH (Lot serial: CONTACT); Model Catalog: S8006KA/KB/KC/KD (Lot serial: CONTACT); Model Catalog: H3900NM (Lot serial: >100 NUMBERS); Model Catalog: H3900JH (Lot serial: >100 NUMBERS)
  • Description du dispositif
    XELERIS NUCLEAR MEDICINE WORKSTATION
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)