Events

Rappel de BRIVO XR285AMX X-RAY SYSTEM

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
    24607
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2012-03-16
  • 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 reason for the recall is because when the collimator is rotated beyond 10 degrees from the 0 degree setting relative to the x-ray tube the total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or the width exceeds 2 percent of the distance from the source to the center of the visually defined field. this is not compliant with iec 60601-1. when the collimator is rotated relative to the x-ray tube the corners of the x-ray field are under exposed or cut off ~3.5% relative to the light field displayed. anatomy located at the extreme corner(s) of the displayed light field may not be captured on the radiographic image resulting in a potential image retake.

Device

BRIVO XR285AMX X-RAY SYSTEM
  • Modèle / numéro de série
    Model Catalog: 5555000 (Lot serial: N/A); Model Catalog: 5555000-2 (Lot serial: N/A); Model Catalog: 5555000-5 (Lot serial: n/a); Model Catalog: 5555000-6 (Lot serial: n/a); Model Catalog: 5555000-3 (Lot serial: n/a); Model Catalog: 5555000-4 (Lot serial: n/a)
  • Description du dispositif
    BRIVO XR285AMX X-RAY SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)