Events

Rappel de VARIS TREATMENT

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
    65263
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2008-11-22
  • 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 malfunction in varis software if undetected could result in an under dose of as much as 100%. commas used instead of decimals for numerical separators with this version 6.6.5042 are not understood properly.

Device

VARIS TREATMENT
  • Modèle / numéro de série
    Model Catalog: PRODUCT CODE: H46 (Lot serial: H462021); Model Catalog: VERSION 6.6.5042 6.6.504 (Lot serial: H462022); Model Catalog: PRODUCT CODE: H46 (Lot serial: H462022); Model Catalog: VERSION 6.6.5042 6.6.504 (Lot serial: H462023); Model Catalog: PRODUCT CODE: H46 (Lot serial: H462023); Model Catalog: VERSION 6.6.5042 6.6.504 (Lot serial: H462024); Model Catalog: PRODUCT CODE: H46 (Lot serial: H462024); Model Catalog: PRODUCT CODE: H46 (Lot serial: H462017); Model Catalog: VERSION 6.6.5042 6.6.504 (Lot serial: H462017); Model Catalog: PRODUCT CODE: H46 (Lot serial: H462016); Model Catalog: VERSION 6.6.5042 6.6.504 (Lot serial: H462016); Model Catalog: VERSION 6.6.5042 6.6.504 (Lot serial: H462021)
  • Description du dispositif
    Varian Medical Varis Treatment System
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.