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
    70181
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-01-12
  • 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
    Software anomaly seen with eclipse electron monte carlo (emc) algorithm where no-equidistant data points in the open beam profile used during configuration may lead to inaccurate results. in a customer report seen (where no patients were involved) beam data collection with non-equidistant data points can lead to inaccurate dose distributions in the treatment plan. the sample dataset from the customer showed a 30% dose difference between the treatment plan isodose plot and the actual delivered dose.

Device

ECLIPSE TPS V8.8
  • Modèle / numéro de série
    Model Catalog: 100042024 (Lot serial: >10 Serial Numbers.); Model Catalog: TPA001075000 (Lot serial: >10 Serial Numbers.); Model Catalog: TPA001075000 (Lot serial: Contact manufacturer.); Model Catalog: 100042024 (Lot serial: Contact manufacturer.); Model Catalog: TPA001094000 (Lot serial: H484530); Model Catalog: TPA001094000 (Lot serial: H484531); Model Catalog: TPA001094000 (Lot serial: H484526); Model Catalog: TPA001094000 (Lot serial: H484527); Model Catalog: TPA001094000 (Lot serial: H484528); Model Catalog: TPA001094000 (Lot serial: H487506); Model Catalog: UP9001 (Lot serial: >10 Serial Numbers.); Model Catalog: UP9001 (Lot serial: Contact manufacturer.)
  • Description du dispositif
    ECLIPSE TPS V8.8
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.