Events

Recall of RayStation 3.0, 3.5, 4.0, 4.5, 4.7, and 5(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-2016-RN-00904-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00904-1
  • 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
    There is an issue with the evaluation of biological clinical goals in raystation 3.0, 3.5, 4.0, 4.5, 4.7, and 5. this issue occurs when adaptive replanning (rayadaptive) is used in combination with biological models (raybiology) and can only occur for a user licensed for rayadaptive and raybiology concurrently. biological clinical goals for an adapted plan based on a new ct (not the planning ct used for the original plan) are evaluated using incorrect dose values and will therefore display incorrect values. the issue is present in all views displaying biological clinical goals, for adapted plans based on a new ct. the magnitude of the error is irregular and largely dependent on the differences between the original planning ct and the new ct. the computed tcp/ntcp values may be smaller or larger than the correct values. the issue has not caused any patient mistreatment or other incidents.
  • Action
    The issue will be resolved in the next version of RayStation, scheduled for market release in December 2016. In the interim, users are advised: - Do not use the values displayed for biological clinical goals in clinical decision making when performing adaptive replanning. - The user is referred to using corresponding biological objective functions or biological functions defined in the Biological Evaluation module. These are evaluated correctly. - As stated in the RayStation Instructions for Use, always evaluate the physical dose.

Device

RayStation 3.0, 3.5, 4.0, 4.5, 4.7, and 5(Radiation therapy treatment planning system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia