Events

Rappel de ECLIPSE TPS V8.8

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
    90044
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-05-16
  • 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 identified with the eclipse treatment planning system where the calculated dose distribution is not updated or invalidated when a recalculation or reload is performed while the compensator or fluence editor is open. this may go unnoticed. proceeding to approve and treat with such a plan can result in the delivered dose distribution not matching the calculated dose distribution. if a dose calculation or plan reload is performed while the compensator or fluence editor dialog is open the resultant dose distribution will be based on the compensator applied prior to edit. when the dialog box is subsequently closed the compensator will be updated. however the calculated dose distribution will not reflect the new compensator. use of the compensator for treatment will result in a dose different from the planned dose. if a verification plan is generated it will be based on the updated compensator such that the error is likely to go undetected.

Device

ECLIPSE TPS V8.8
  • Modèle / numéro de série
    Model Catalog: 100042024 (Lot serial: Contact manufacturer.); Model Catalog: TPA001075000 (Lot serial: H482173); Model Catalog: 100042024 (Lot serial: >10 serial numbers.); Model Catalog: TPA001075000 (Lot serial: H481730); Model Catalog: UP9001 (Lot serial: Contact manufacturer.); Model Catalog: UP9001 (Lot serial: >10 serial numbers.)
  • Description du dispositif
    ECLIPSE Treatment Planning System V8.8
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.