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
    27320
  • 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 has been identified with varian eclipse treatment planning system and aria radiation oncology (rt chart application) where adding a reference point in aria rt chart and editing the field dose contributions may change the prescribed dose per fraction in eclipse. a reference point added in aria rt chart does not have a location and is sometimes referred to as a "dose prescription volume" or dpv. if a reference point without location or dpv is added in aria rt chart and the field dose contribution of the reference point is edited this may cause the dose per fraction and total prescribed dose of an unapproved treatment plan in eclipse to change. this anomaly can occur when there is plan normalization such that the total done and the total dose at primary have different values.

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 V8.8
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.