Events

Recall of Eclipse Treatment Planning System, (Radiation therapy treatment planning system), version 11Version 11 with PBC 11.0.21, 11.0.30

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-00105-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-02-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00105-1
  • 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
    The final calculated dose of dose dynamic fields will be incorrect when both conditions occur:1. the pencil beam convolution [pbc] 11 algorithm license feature is used,2. either the energy and/or the treatment unit of a dose dynamic field, differs fromthat of the first created treatment field in the plan.Under these conditions, the final dose calculation will determine the mu to dose calibration (mugy10) factor and the applicable dose rate table value (csbf coefficient) using the energy of the first treatment field (in the order of creation) for all dose dynamic fields, regardless of the actual field energy.
  • Action
    Varian Medical Systems is requesting users to not use the Pencil Beam Convolution (PBC) 11 algorithm for dose dynamic plans. It is recommended that dynamic MLC plans are calculated with the AAA or Acuros XB algorithm. PBC versions prior to version 11 can still be used. Varian recommends a review of treated patient plans where the PBC 11 algorithm was used for the calculation of dose dynamic plans. A technical correction is under development and will be implemented once complete.

Device

Eclipse Treatment Planning System, (Radiation therapy treatment planning system), version 11Versi...

Manufacturer

Varian Medical Systems Australasia Pty Ltd