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
    113924
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-08-16
  • 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
    An anomaly has been found with the clinac trilogy novalis tx and unique jaw carriers. the jaw carriers function to couple the x-jaws to their respective drive screw mechanisms used for controlling field size. some jaw carriers were manufactured with the incorrect metal alloy which can potentialy cause the jaw carrier to crack. if both jaw carriers on the same x-jaw were to crack the jaw would be able to move freely in the closed direction. in this case the deviation of the jaw position will not be detected by the position readout interlock circuitry. treatment after such a failure occurs may lead to an under -dose of the intended target volume.

Device

TRILOGY HIGH ENERGY LINEAR ACCELERATOR
  • Modèle / numéro de série
    Model Catalog: TRILOGY (Lot serial: H294674); Model Catalog: CLINAC IX (Lot serial: H294758); Model Catalog: CLINAC IX (Lot serial: H294684); Model Catalog: NOVALIS TX (Lot serial: H294751); Model Catalog: CLINAC IX (Lot serial: H294766); Model Catalog: CLINAC IX (Lot serial: H294683); Model Catalog: CLINAC IX (Lot serial: H294750); Model Catalog: CLINAC IX (Lot serial: H294675)
  • Description du dispositif
    Trilogy High Energy Linear Accelerator
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.