Events

Rappel de CLINAC IX RADIO THERAPY DELIVERY SYSTEM

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
    132987
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-01-13
  • 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 was discovered in which under certain circumstances of control circuit adjustments and component failure a c-series clinac can beam on with an asymmetric electron beam which is undetected by the interlocks intended to prevent it. the anomaly can occur in the rare event a balance potentiometer in the electron programming pcb fails and the other circuit settings are such that the effect is not detected.

Device

CLINAC IX RADIO THERAPY DELIVERY SYSTEM
  • Modèle / numéro de série
    Model Catalog: CLINAC IX (Lot serial: Contact manufacturer.); Model Catalog: CLINAC IX (Lot serial: >10 serial numbers.); Model Catalog: 23EX (Lot serial: >10 serial numbers.); Model Catalog: 21EX (Lot serial: >10 serial numbers.); Model Catalog: 2100C/D (Lot serial: >10 serial numbers.); Model Catalog: 2300C/D (Lot serial: >10 serial numbers.); Model Catalog: 21EX (Lot serial: Contact manufacturer.); Model Catalog: 23EX (Lot serial: Contact manufacturer.); Model Catalog: 2100C/D (Lot serial: Contact manufacturer.); Model Catalog: 2300C/D (Lot serial: Contact manufacturer.); Model Catalog: TRILOGY (Lot serial: H293883); Model Catalog: TRILOGY (Lot serial: H294403); Model Catalog: TRILOGY (Lot serial: H291172); Model Catalog: TRILOGY (Lot serial: H294134); Model Catalog: TRILOGY (Lot serial: H140836); Model Catalog: TRILOGY (Lot serial: H291166); Model Catalog: TRILOGY (Lot serial: H293787)
  • Description du dispositif
    Clinac IX Radiotherapy Delivery System
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.