Events

Rappel de OPTIMA XR200AMX X-RAY 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
    27253
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2012-05-28
  • 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
    In some instances the user interface on the system may appear as though it has ceased responding to commands. in this case while the interface may not reflect any of the changes being commanded to the user it is in actuality updating the system computer with the commands requested. this may result in a situation where the user interface indicates a different technique selection than is actually selected on the system. therefore the potential exists for the system to perform a different technique selection for an exposure than may be indicated to the user.

Device

OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT
  • Modèle / numéro de série
    Model Catalog: 5555000-3 (Lot serial: N/A); Model Catalog: 5555000-4 (Lot serial: N/A); Model Catalog: 5555000-5 (Lot serial: N/A); Model Catalog: 5555000-6 (Lot serial: N/A)
  • Description du dispositif
    OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)