Events

Rappel de RaySearch RayStation 4.5, 4.7, 5, and 6(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-2017-RN-00133-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-25
  • 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-2017-RN-00133-1
  • 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
    Due to a known error in nvidia graphics processing unit (gpu) card drivers, raysearch has prevented gpu based computations for very large computation problems. in an incorrect citrix xenapp configuration, the gpu may not be correctly identified and the erroneous calculation may be allowed. if this occurs, accelerated computation on gpu may give incorrect results for very large computation problems. dose computation will be affected if the dose grid contains more than 134217728 voxels for a photon plan or more than 67108864 voxels for a carbon ion plan. the main effect on calculated dose is that it may be incorrectly set to zero in parts of the dose grid. normally this would be highly detectable. there may also be some smaller impact on the dose in the non-zero region. deformable registration may be affected for large image sets. in a correct citrix xenapp and gpu installation by raysearch, the issue would not occur.
  • Action
    Users are advised to verify the GPU settings on each of the Citrix XenApp servers according to the instructions in the customer letter. A correct configuration of the RayStation GPU settings will show a graphics board that has been verified by RaySearch. Add the RSL-D-61-320-EN-1.0 RayStation 4.5, 4.7, 5 and 6 Additional System Environment Acceptance Test Protocol GPU to the location of the RayStation manuals. The tests in the Additional System Environment Acceptance Test Protocol GPU must be performed in addition to the tests in the System Environment Acceptance Test Protocol to verify GPU computations whenever the hardware or software platform is changed. This action has been closed-out on 01/03/2018.

Device

RaySearch RayStation 4.5, 4.7, 5, and 6(Radiation therapy treatment planning system)
  • Modèle / numéro de série
    RaySearch RayStation 4.5, 4.7, 5, and 6(Radiation therapy treatment planning system)Build Numbers: 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24ARTG Number: 195288
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia