Events

Recall of Eclipse Treatment Planning System, ARIA Radiation Oncology (treatment plan and image management application) and Acuity Radiation Therapy Simulator Software versions 11 and 13

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-2013-RN-01301-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-12-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01301-1
  • 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 anomaly has been identified with the plan parameters workspace within eclipse treatment planning system, aria, and acuity. when a dose relevant parameter is changed and "do not clear mus and reference point dose" is selected, the monitor units (mus) may change without the user being aware of the changes. when the user follows a specific set of conditions, the dose is rescaled such that the 100% isodose is shifted to the primary reference point location. consequently, the mus for each treatment field will change and will not meet the dose prescription intended. for example, if the dose prescription percentage was 85% in the original plan, and a dose relevant parameter is changed, the dose prescription percentage will rescale to 100%. the monitor units will be correspondingly increased. thus, the plan will no longer meet the intended dose prescription.
  • Action
    Users are advised not to use the Plan Parameters workspace to modify 3D Treatment Plans containing a 3D dose. When it is necessary to edit patient treatment plans containing 3D dose, this action must be performed in Eclipse External Beam Planning or in the applicable treatment planning system. Varian Medical Systems recommends a thorough review of treated patient plans for plans with a primary reference point with geometric location and where modifications were made in the Plan Parameter workspace. Varian Medical Systems is currently developing a technical correction for this issue. This action has been closed-out on 11/02/2016.

Device

Eclipse Treatment Planning System, ARIA Radiation Oncology (treatment plan and image management a...
  • Model / Serial
    Eclipse Treatment Planning System, ARIA Radiation Oncology (treatment plan and image management application) and Acuity Radiation Therapy SimulatorSoftware versions 11 and 13Product codes: H48, HIT and H77ARTG Numbers: 119983, 132638, 119995
  • Product Classification
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd