Events

Rappel de ECLIPSE SMART SEGMENTATION

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
    31043
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-07-19
  • 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 certain aaa versions where the second source modeling for imrt fields with multiple carriage groups is incorrect. in affected aaa versions when modeling the second source the collimator jaw positions are read from the first control point of the field. this can cause an underestimation of the dose when calculating an imrt field which has multiple carriage groups. when the plan is delivered the delivered dose can be higher than planned locally by up to 10%.

Device

ECLIPSE SMART SEGMENTATION
  • Modèle / numéro de série
    Model Catalog: TPA001094000 (Lot serial: Contact manufacturer.); Model Catalog: TPA001094000 (Lot serial: >10 Serial numbers.); Model Catalog: UP9001 (Lot serial: >10 serial numbers.); Model Catalog: UP9001 (Lot serial: Contact manufacturer.); Model Catalog: TPA001075000 (Lot serial: >10 Serial numbers.); Model Catalog: TPA001075000 (Lot serial: Contact manufacturer.); Model Catalog: 100042024 (Lot serial: H48C062); Model Catalog: 100042024 (Lot serial: H48C063); Model Catalog: 100042024 (Lot serial: H48A242); Model Catalog: 100042024 (Lot serial: H48A478)
  • Description du dispositif
    ECLIPSE SMART SEGMENTATION
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.