Events

Recall of Eclipse Treatment Planning System (Radiation treatment planning system); Version 8.5, 8.6, 8.9, 10 & 11

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Varian Medical Systems Australasia Pty Ltd.

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-2012-RN-00652-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00652-3
  • 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 anomaly has been identified with the eclipse treatment planning system where changing the prescription in a calculated vmat or rapidarc plan may lead to monitor units which do not reflect the new prescription. if the dose prescription of a vmat or rapidarc plan is changed after the initial dose volume optimisation, the monitor units and dose distribution may not reflect the intended prescription.
  • Action
    Varian is recommending users to implement work around instructions until a software fix is developed and implemented.

Device

Eclipse Treatment Planning System (Radiation treatment planning system); Version 8.5, 8.6, 8.9, 1...
  • Model / Serial
    Eclipse Treatment Planning System (Radiation treatment planning system); Version 8.5, 8.6, 8.9, 10 & 11Multiple Serial Numbers affectedProduct Code: H48ARTG Number: 119983
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd