Events

Recall of Eclipse Treatment Planning System, (radiation therapy treatment planning system). Versions: 8.9 and 10

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-00920-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-09-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00920-1
  • 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
    When the clock on the eclipse client workstation is running behind the clock on the database/system server, it is possible that a change to the assigned hu value for a structure dose not invalidate the density image stored in the cache, and for the subsequent dose and monitor unit calculation to be based on the outdated hu assignment. the resultants mus may be higher or lower than expected. treatment of the patient using these values can lead to under or overdosing.
  • Action
    Varian is providing users with work around instructions and will be providing a technical correction to permanently correct the issue when available.

Device

Eclipse Treatment Planning System, (radiation therapy treatment planning system). Versions: 8.9 a...
  • Model / Serial
    Eclipse Treatment Planning System, (radiation therapy treatment planning system). Versions: 8.9 and 10Product Code: H48Multiple serial numbers affectedARTG Number: 119983
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd