Events

Rappel de ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)

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
    94139
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-05-17
  • 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
    When multiple conical collimator treatment plans are scheduled to be treated in a session the plan label should be displayed on the bccv dialog box should match the plan label on the 4ditc. however the name of the plan is not being updated correctly. all other identifiers including the accessory mount (conical collimator) are correct and are displayed correctly. a report was received involving the 4d integrated treatment console (4ditc) and bar - code conical collimator (bccv) indicating that the plan label is not updated correctly in bccv display if multiple plans are open in 4ditc simulatenously.

Device

ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)
  • Modèle / numéro de série
    Model Catalog: V8.8 (Lot serial: H513769); Model Catalog: BCCV (Lot serial: HBC0210); Model Catalog: BCCV (Lot serial: HBC0028); Model Catalog: V8.8 (Lot serial: H515461)
  • Description du dispositif
    ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.