Events

Rappel de NOVALIS TX 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
    130306
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-06-29
  • 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 whereby following prolonged use the screw fastener holding the wedge body to the tray may fail. the falling wedge presents a risk of injury to patients or other personnel in the path of the falling wedge. the risk of failure is proportional to the amount of use of the wedge and is considered significant only after many years of use. the risk is also increased for heavier wedges upper wedges used in the interface mount and for wedges where the screw fasteners are loose or have a history of becoming loose. varian is aware of this occuring only for 30 degree upper wedges. other wedges may potentially be susceptible to the same failure.

Device

NOVALIS TX LINEAR ACCELERATOR
  • Modèle / numéro de série
    Model Catalog: NOVALIS TX (Lot serial: H294674); Model Catalog: TRILOGY (Lot serial: H294750); Model Catalog: TRILOGY (Lot serial: H294403); Model Catalog: TRILOGY (Lot serial: H294934); Model Catalog: TRILOGY (Lot serial: H291172); Model Catalog: TRILOGY (Lot serial: H293883); Model Catalog: TRILOGY (Lot serial: H294134); Model Catalog: TRILOGY (Lot serial: H140836); Model Catalog: TRILOGY (Lot serial: H294551); Model Catalog: TRILOGY (Lot serial: H293787); Model Catalog: TRILOGY (Lot serial: H291166); Model Catalog: (Lot serial: Contact Manufacturer.); Model Catalog: (Lot serial: >10 Serial Numbers.); Model Catalog: CLINAC IX (Lot serial: >10 Serial Numbers.); Model Catalog: CLINAC IX (Lot serial: Contact Manufacturer.)
  • Description du dispositif
    NOVALIS TX LINEAR ACCELERATOR
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.