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
    104970
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-08-21
  • 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
    Eclipse treatment planning system where an outdated assigned hounsfield unit [hu] value can be used for dose calculation when the clock on the eclipse client worstation is not synchronized with the database / system server. when the eclipse client workstation clock is running behind the clock on the database/ system server it is possible that a change to the assigned hu value for a structure does not invalidate the density image stored in the cache and for the subsequent dose and monitor unit [mu] calculation to be based on the outdated hu assignment. the resultant mus may be higher or lower than expecteddependent on the specific hu assignments. treatment of the patient using these values can therefore lead to under - or over dose.

Device

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

Manufacturer

VARIAN MEDICAL SYSTEMS INC.