Events

Recall of RayStation 3.5 and 4.0 (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-2014-RN-00173-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00173-1
  • 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
    The manufacturer has become aware of an issue found with the dose calculation in raystation 3.5 and 4.0. the error appears in some situations for bolus/external/fixation/support structures that are outside the image stack but covered by the dose grid. when converted to dose grid structures, they are cut off at the image stack boundaries (first and last slice) in the inferior-superior direction. for a bolus/external/fixation/support structure this means that the part outside the image stack does not contribute to the density distribution and the dose calculation will be affected and may result in under dosing.
  • Action
    Emergo is advising users to avoid the creation of treatment plans where the beam passes through a support or a fixation which is not imaged and where the support or fixation is placed on the superior or inferior side of the CT stack. Emergo is recommending the external ROI is not extended past the CT stack in the inferior or superior direction. If a bolus is used for the superior or inferior beams, users are advised to image enough slices above the patient head to fit the bolus inside the CT stack. Emergo is recommending users do not use dose tracking with oblique beams entering through the superior or inferior CBCT slice. A software patch will be installed on all affected users to correct the issue.

Device

RayStation 3.5 and 4.0 (Radiation therapy treatment planning system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia