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
    42986
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-06-29
  • 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
    Under certain specific circumstances the gantry rotates in the opposite direction to that specified according to the plan parameters when moving from one field to the next. if the patient couch or other medical equipment isi n the path of the gantry damage to property or injury to a patient could occur. according to varian iec scale the gantry will rotate clockwise (cw) from 0.0 degrees to 180.0 degrees and counterclockwise from 0.0 degrees to 180.0e degrees. by default when a user creates an opposing field within a plan that contains static fields the gantry rotation is set to rotate in the clockwise direction. for situations when that is not desired a user activated extended angle flag is provided to cause the gantry to rotate in a counterclockwise direction.

Device

ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC)
  • Modèle / numéro de série
    Model Catalog: V8.8 (Lot serial: >10 Serial numbers.); Model Catalog: V8.6 (Lot serial: >10 Serial numbers.); Model Catalog: V8.1.2 (Lot serial: >10 Serial numbers.); Model Catalog: V8.8 (Lot serial: Contact manufacturer.); Model Catalog: V8.6 (Lot serial: Contact manufacturer.); Model Catalog: V8.1.2 (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.