Events

Rappel de MILLENNIUM VG VARIABLE GEOMETRY DUAL DETECTOR CAMERA

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
    75668
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-02-07
  • 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
    Ge healthcare has recently become aware of a potential safety issue related to unintended radial detector motion which may occur during patient setup or at the end of a patient scan. this failure mode has been observed on a single system for a whole body scan in which the detector moved to the home position and then slowly started drifting inward toward the patient.

Device

MILLENNIUM VG VARIABLE GEOMETRY DUAL DETECTOR CAMERA
  • Modèle / numéro de série
    Model Catalog: H3000YA (Lot serial: N/A); Model Catalog: NIL (Lot serial: N/A); Model Catalog: H3000WW (Lot serial: N/A); Model Catalog: H3000WT (Lot serial: N/A); Model Catalog: H3000WC/WD (Lot serial: N/A); Model Catalog: H3000YM (Lot serial: N/A); Model Catalog: H3000WZ (Lot serial: N/A); Model Catalog: H3000YS (Lot serial: N/A)
  • Description du dispositif
    Millennium VG Variable Gemetry Dual Detector Cam
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)