Events

Rappel de ARIA RADIATION THERAPY MANAGEMENT

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
    44650
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-10-01
  • 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 was identified with the aria for radiation oncology software with a clinical assessment license. admin instructions may not print on drug order prescriptions or be transmitted with e-rx. when the user changes the prescription "type" field after inputting admin instructions in the text box the admin instructions portion of the prescription will not be saved to the database. an e-rx transmitted to the pharmacy will not contain the intended admin instructions. the printed prescription will also not contain the intended admin instructions. this anomaly only occurs for sites that have a clinical assessment license for the aria radiation oncology software / licence set. aria users who do not have a clinical assessment license will not be affected.

Device

ARIA RADIATION THERAPY MANAGEMENT
  • Modèle / numéro de série
    Model Catalog: 7 9 5 8 5 3 (Lot serial: Contact manufacturer.); Model Catalog: 795853 (Lot serial: >10 serial numbers.); Model Catalog: 7 9 5 8 5 3 (Lot serial: >10 serial numbers.); Model Catalog: 795853 (Lot serial: Contact manufacturer.)
  • Description du dispositif
    Aria Radiation Therapy Management
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.