Events

Rappel de VARIS - 4D INTEGRATED TREATMENT CONSOLE (4DITC)

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
    130916
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2009-11-17
  • 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
    Malfunction when adding cbct image. present software has ability to acquire gantry angle when 'treatment approval enforced' and/or 'allow only couch parameter (vert long lat) editing & acquiring for approved plans' selected in treatment administration. therapists can acquire gantry angle into plan even without system rights to acquire gantry angle. patient treated with wrong gantry angles one day.

Device

VARIS - 4D INTEGRATED TREATMENT CONSOLE (4DITC)
  • Modèle / numéro de série
    Model Catalog: 8.0.23 SP2 (Lot serial: manufacturer.); Model Catalog: 8.0.12 (Lot serial: >10 serial numbers. Contact); Model Catalog: 8.0.23 SP2 (Lot serial: >10 serial numbers. Contact); Model Catalog: 8.1 SP2 (Lot serial: >10 serial numbers. Contact); Model Catalog: 8.1.1.3 (Lot serial: >10 serial numbers. Contact); Model Catalog: H51 (Lot serial: manufacturer.); Model Catalog: 8.8.0 (Lot serial: manufacturer.); Model Catalog: 8.6.2 (Lot serial: manufacturer.); Model Catalog: 8.6.1 (Lot serial: manufacturer.); Model Catalog: 8.6 (Lot serial: manufacturer.); Model Catalog: 8.3 (Lot serial: manufacturer.); Model Catalog: 8.1.4 (Lot serial: manufacturer.); Model Catalog: 8.1.3 (Lot serial: manufacturer.); Model Catalog: 8.1.2 (Lot serial: manufacturer.); Model Catalog: 8.1.1.4 (Lot serial: manufacturer.); Model Catalog: 8.1.1.3 (Lot serial: manufacturer.); Model Catalog: 8.1 SP2 (Lot serial: manufacturer.); Model Catalog: 8.0.12 (Lot serial: manufacturer.); Model Catalog: H51 (Lot serial: >10 serial numbers.
  • Description du dispositif
    Varis 4D Integrated Treatment Console
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.