Events

Rappel de RaySearch RayStation, version 4.0.3 (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-2014-RN-00489-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-04-29
  • 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-2014-RN-00489-1
  • 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
    The manufacturer, raysearch laboratories has identified a problem with the computation of roi voxel volumes for cases where the ct has variable slice spacing. the dose grid volumetric representation of an roi can be wrong. this affects all dose-volume properties for such rois, including dvh, dose statistics, clinical goals and constraints or objective functions. furthermore, if material override rois are used, or if the external is not represented by contours, the bug can trigger an error in the 3d dose distribution. the problem has, to the best of raysearch laboratories' knowledge, not caused any patient mistreatment.
  • Action
    This problem will be resolved in a future release of RayStation. Customers wanting to continue to use variable slice spacing should contact their Support representative for workarounds. RayStation 4.0.3 may not be used with CT data where variable slice spacing has been used, until a workaround has been provided. For now, applicable CT scanners should, if possible, be configured to uniform slice spacing. If there are patient plans with variable CT slice spacing being used for treatment, please contact Support representative for assistance on identifying if the problem is present and workarounds. The database of patients planned with RayStation 4.0.3 should be analysed for identification of potential errors in dose analysis for completed treatments. This action has been closed-out on 01/02/2016.

Device

RaySearch RayStation, version 4.0.3 (Radiation therapy treatment planning system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia