Events

Recall of RaySearch RayStation 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-00717-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00717-1
  • 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
    This notice concerns an issue found with the treatment plan report in raystation 5. for a treatment plan with multiple beam sets, the table for region of interest (roi) plan dose statistics in the report may show the statistics for a beam set dose instead of the plan dose. in the case where a clinical decision is based on the erroneous roi plan dose statistics, a patient could potentially receive a higher than acceptable radiation dose. the error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics. for such a report template, all reports for multiple beam set plans would always be affected.
  • Action
    Users are advised to inspect all report templates that are intended to be used for plan with multiple beam sets, and to ensure that "POI Dose Statistics (Plan)" is included immediately before "ROI Dose statistics [Plan dose]" in the report content area. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 16/02/2017.

Device

RaySearch RayStation 5 (Radiation therapy treatment planning system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia