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
    84776
  • 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
    In affected eclipse versions user editing of mlc leaf positions may not automatically invalidate calculated dose distributions. eclipse calculates dose for each field in a treatment plan and when all fields are calculated dose is summed and displayed to the user. if a treatment plan has been saved then reloaded from the database for additional planning activities user repositioning of mlc leaves may not invalidate or "clear" the calculated field dose. this condition is a result of how items are loaded into memory and subsequently handled for efficiency memory use when fields and mlc are saved and then recalled from database system defaults specify that objects may be unloaded from memory if 90% of available resources are consumed or as a periodic system maintenance task when the application is open for longer than 12 hours. in the rare instance that an mlc "object" is unloaded from memory due to one of these conditions the dose for that field will nolonger be conditional to the state of the mlc. in this case a change in the mlc leaf positions would not cause the field dose to be invalidated. this may go unnoticed if another field in the plan is not calculated and the total dose is not currently dislayed to the user.

Device

ECLIPSE SMART SEGMENTATION
  • Modèle / numéro de série
    Model Catalog: TPA001094000 (Lot serial: H484528); Model Catalog: TPA001094000 (Lot serial: H487407); Model Catalog: TPA001094000 (Lot serial: H487506); Model Catalog: TPA001094000 (Lot serial: H484527); Model Catalog: TPA001094000 (Lot serial: H484530); Model Catalog: UP9001 (Lot serial: >10 Serial Numbers.); Model Catalog: UP9001 (Lot serial: Contact manufacturer.); Model Catalog: TPA001094000 (Lot serial: H484531); Model Catalog: TPA001094000 (Lot serial: H484526); Model Catalog: 100042024 (Lot serial: >10 Serial numbers.); Model Catalog: 100042024 (Lot serial: Contact manufacturer.); Model Catalog: TPA001075000 (Lot serial: >10 Serial numbers.); Model Catalog: TPA001075000 (Lot serial: Contact manufacturer.)
  • Description du dispositif
    ECLIPSE SMART SEGMENTATION
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.