Events

Recall of RayStation software versions 2.5, 3.0, 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-00144-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00144-1
  • 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 hybrid deformable registration in raystation 2.5, 3.0, 3.5, and 4.0. rigid registration is a standard first step prior to running a hybrid deformation. the rotation component of the rigid registration computed prior to the deformable registration is not accounted for in fusion views when mapping structures (regions or points of interest) or when deforming dose.
  • Action
    Emergo is advising their customers to ensure that the "discard rotation" option is selected in the Image Registration Module before creating a rigid registration intended to be used for hybrid deformable registration. End users can also use the ROI based deformable registration when applicable as this functionality is not affected by the error. A software patch will be release to correct this problem.

Device

RayStation software versions 2.5, 3.0, 3.5, and 4.0 (radiation therapy treatment planning system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia