Events

Rappel de RaySearch RayStation 5 (Radiation therapy treatment planning system)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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
    RC-2016-RN-00717-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-08
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00717-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    This notice concerns an issue found with the treatment plan report in raystation 5. for a treatment plan with multiple beam sets, the table for region of interest (roi) plan dose statistics in the report may show the statistics for a beam set dose instead of the plan dose. in the case where a clinical decision is based on the erroneous roi plan dose statistics, a patient could potentially receive a higher than acceptable radiation dose. the error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics. for such a report template, all reports for multiple beam set plans would always be affected.
  • Action
    Users are advised to inspect all report templates that are intended to be used for plan with multiple beam sets, and to ensure that "POI Dose Statistics (Plan)" is included immediately before "ROI Dose statistics [Plan dose]" in the report content area. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 16/02/2017.

Device

RaySearch RayStation 5 (Radiation therapy treatment planning system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia