Events

Recall of RayStation 3.0, 3.5, 4.0, 4.5 and 4.7 (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-00182-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00182-1
  • 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
    A software bug has been reported that when using certain roi (region of interest) editing tools, if simultaneously right clicking, pressing ctrl-s or ctrl-z while the left mouse button is held down, the views can appear as if the left mouse button had been released to complete editing. in order for the bug to cause saving of an unintended state, it has to be triggered during the very last edit made to the roi. saving of an unintended state may lead to ineffective and/or unintended radiation therapy. the patient views and the beam’s eye view will always be displayed correctly in the plan approval dialog and in the plan reports. closing and reloading a case will always generate correct views. dose is always computed based on the stored system state.
  • Action
    This issue will be resolve after the installation of RayStation 5 Service Pack 1, which was released Q1 2016. In the interim, users are advised to: -Always release the left mouse button before using other keys or mouse buttons. -If the warning message “Temporary items should not be visible on approval” is displayed or if there is some suspicion that the bug may have been triggered in structure definition, either review the structures in the Plan approval dialog, or close and reload the patient case and review the structures again. This action has been closed-out on 06/02/2017.

Device

RayStation 3.0, 3.5, 4.0, 4.5 and 4.7 (Radiation therapy treatment planning system)
  • Model / Serial
    RayStation 3.0, 3.5, 4.0, 4.5 and 4.7 (Radiation therapy treatment planning system)Software build number : 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 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 or 4.7.4.4ARTG Number: 195288
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia