Events

Rappel de CLINAC 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
    51828
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-04-20
  • 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
    Collimator cover is falling from the linear accelerator. it appears the collimator cover was not properly installed and that motion of the linear accelerator caused the cover to detach and fall from the machine. it was determined that the collimator latching mechanism may be difficult to latch properly resulting in an increased likelihood of accidental detachment of the collimator cover.

Device

CLINAC LINEAR ACCELERATOR
  • Modèle / numéro de série
    Model Catalog: 6EX (Lot serial: H180605 (600C Unit)); Model Catalog: 600C (Lot serial: H180600 (600C Unit)); Model Catalog: 6EX (Lot serial: H180796 (6EX Unit)); Model Catalog: 600C (Lot serial: H180796 (6EX Unit)); Model Catalog: 6EX (Lot serial: H180683 (6EX Unit)); Model Catalog: 600C (Lot serial: H180683 (6EX Unit)); Model Catalog: 6EX (Lot serial: H180619 (6EX Unit)); Model Catalog: 600C (Lot serial: H180619 (6EX Unit)); Model Catalog: 6EX (Lot serial: H272910 (6EX unit)); Model Catalog: 600C (Lot serial: H272910 (6EX unit)); Model Catalog: 6EX (Lot serial: H293787 (600C Unit)); Model Catalog: 600C (Lot serial: H293787 (600C Unit)); Model Catalog: 6EX (Lot serial: H291180 (600C Unit)); Model Catalog: 600C (Lot serial: H291180 (600C Unit)); Model Catalog: 6EX (Lot serial: H180600 (600C Unit)); Model Catalog: 600C (Lot serial: H180605 (600C Unit)); Model Catalog: NOVALIS TX (Lot serial: H272857); Model Catalog: 2100C (Lot serial: H272118); Model Catalog: 2100C (Lot serial: H271662); Model Catalog: 2100C (
  • Description du dispositif
    CLINAC LINEAR ACCELERATOR
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.