Events

Rappel de ARIA OFFLINE REVIEW SOFTWARE

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
    135800
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2009-06-10
  • 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 exists in the software which leads to a record save fail in the case that a partially treated fraction has zero dose accumulation. if the change to the plan had been to parameters other than dose per fraction treatment to incorrect volume could resultpotentially leading to serious injury.

Device

ARIA OFFLINE REVIEW SOFTWARE
  • Modèle / numéro de série
    Model Catalog: HIT (Lot serial: contact manufacturer.); Model Catalog: 8.6.07 (Lot serial: contact manufacturer.); Model Catalog: 8.5.11 (Lot serial: contact manufacturer.); Model Catalog: 8.1.15 (Lot serial: contact manufacturer.); Model Catalog: HIT (Lot serial: >10 serial numbers.); Model Catalog: 8.1.15 (Lot serial: >10 serial numbers.); Model Catalog: 8.6.07 (Lot serial: >10 serial numbers.); Model Catalog: 8.5.11 (Lot serial: >10 serial numbers.); Model Catalog: HIT (Lot serial: contact manufacturer); Model Catalog: 8.6.07 (Lot serial: contact manufacturer); Model Catalog: 8.5.11 (Lot serial: contact manufacturer); Model Catalog: 8.1.15 (Lot serial: contact manufacturer)
  • Description du dispositif
    Aria Offline Review Software
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.