Events

Rappel de CLINAC 2100C 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
    27100
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-01-12
  • 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
    A problem could occur where user may calibrate collimator angle position readout in reverse switching the 90 degree and 270 degree positions. this could cause patient treatment with the wrong collimator angle for any collimator angle other than 0 degrees iec. a reversed calibration could cause any attempt to perform a remote auto motion of the collimator to result in a failure to reach the target position. in this case the collimator would rotate in the direction opposite the proper direction to reach the target angle and would reach the mechanical limit before reaching the target angle.

Device

CLINAC 2100C HIGH ENERGY LINEAR ACCELERATOR
  • Modèle / numéro de série
    Model Catalog: 2100C (Lot serial: Contact manufacturer.); Model Catalog: 23EX (Lot serial: H290285); Model Catalog: TRILOGY (Lot serial: >10 Serial numbers.); Model Catalog: TRILOGY (Lot serial: Contact manufacturer.); Model Catalog: 2100C (Lot serial: >10 Serial numbers.); Model Catalog: 6EX (Lot serial: Contact manufacturer.); Model Catalog: CLINAC IX (Lot serial: >10 Serial numbers.); Model Catalog: CLINAC IX (Lot serial: Contact manufacturer.); Model Catalog: 600C (Lot serial: >10 Serial Numbers.); Model Catalog: 6EX (Lot serial: >10 Serial Numbers.); Model Catalog: NOVALIS TX (Lot serial: H294674); Model Catalog: 600C (Lot serial: Contact manufacturer.); Model Catalog: 21EX (Lot serial: Contact manufacturer.); Model Catalog: 21EX (Lot serial: >10 Serial numbers.)
  • Description du dispositif
    CLINAC 2100C HIGH ENERGY LINEAR ACCELERATOR
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.