Events

Rappel de RaySearch RayStation 3.0 and 3.5 (software versions 3.0.0.251, 3.5.0.16, 3.5.1.6) (Radiation treatment planning and analysis software) Date Manufactured: 15/02/2013

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-2013-RN-00734-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-07-19
  • 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-2013-RN-00734-1
  • 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
    Under certain conditions resampling of regions of interest (roi) geometries to the dose grid representation is not correctly calculated, and an additional voxel layer is added incorrectly on the superior side of each roi. the problem is more pronounced for very small roi's, leading to over-estimation of dose maximum and under-estimation of the minimum dose.The above problem also affects dose calculated with material overrides, however this should cause no noticeable impact.
  • Action
    Emergo are providing work around instructions for users to follow. The issue will be corrected in RayStation software version 4.0 which is due for release in July 2013.

Device

RaySearch RayStation 3.0 and 3.5 (software versions 3.0.0.251, 3.5.0.16, 3.5.1.6) (Radiation trea...
  • Modèle / numéro de série
    RaySearch RayStation 3.0 and 3.5 (software versions 3.0.0.251, 3.5.0.16, 3.5.1.6) (Radiation treatment planning and analysis software)Date Manufactured: 15/02/2013ARTG Number: 195288
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia