Events

Recall of RaySearch RayStation 4.5, 4.7, 5, and 6(Radiation therapy treatment planning system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00133-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00133-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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)
  • Model / Serial
    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