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
    86960
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-05-03
  • 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
    It has been identified that in certain configurations the 4ditc can interpret a rapidarc or vmat treatment field as 3d conformal arc treatment plan. if a rapidarc or vmat treatment field is incorrectly interpreted as conformal arc the field will be delivered with a constant dose rate and gantry speed for the entire duration of the delivery which can lead to delivered dose being different than planned. this will only happen when the change in mu / deg between consecutive control points is small. in other words it can only happen when the dose rate or gantry speeds vary in a very smooth and progressive way for the entire rapidarc field. rapidarc treatment plans created with eclipse 8.2 and higher or potentially vmat treatment plans created with 3rd party treatment planning systems when delivered on the 4ditc v8.6 and v8.8 can be incorrectly identified as 3d conformal arc treatment plan.

Device

ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)
  • Modèle / numéro de série
    Model Catalog: V8.6 (Lot serial: >10 serial numbers.); Model Catalog: V8.8 (Lot serial: >10 serial numbers.); Model Catalog: V8.6 (Lot serial: Contact manufacturer.); Model Catalog: V8.8 (Lot serial: Contact manufacturer.)
  • Description du dispositif
    Aria Practice Management 4D Integrated Treatment Console (4DITC)
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.