Events

Rappel de TRILOGY HIGH ENERGY LINEAR ACCELERATOR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par VARIAN MEDICAL SYSTEMS INC..

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
    85027
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-07-12
  • 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
    An anomaly has been identified with the high - energy clinac gantry center throat cover where the cover may lean toward isocenter far enough to strike a patient. this issue is limited to center throat covers on high energy clinacs (h14 h27 h29) with v1.0 of the obi kv imaging system. these covers are associated with the obi air-cooled kv x-ray tube. other center throat covers use a different design.

Device

TRILOGY HIGH ENERGY LINEAR ACCELERATOR
  • Modèle / numéro de série
    Model Catalog: (Lot serial: H291166); Model Catalog: (Lot serial: H080220); Model Catalog: (Lot serial: H080286); Model Catalog: (Lot serial: H082013); Model Catalog: (Lot serial: H080059); Model Catalog: (Lot serial: H080217); Model Catalog: (Lot serial: H080213); Model Catalog: (Lot serial: H291172); Model Catalog: (Lot serial: H080194); Model Catalog: (Lot serial: H080268); Model Catalog: (Lot serial: H080060); Model Catalog: (Lot serial: H291194); Model Catalog: (Lot serial: H291021); Model Catalog: (Lot serial: H291178); Model Catalog: (Lot serial: H291016); Model Catalog: (Lot serial: H293307); Model Catalog: (Lot serial: H272370); Model Catalog: (Lot serial: H272407)
  • Description du dispositif
    TRILOGY HIGH ENERGY LINEAR ACCELERATOR
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.