Events

Recall of Eclipse Treatment Planning System v 11, 13.0, 13.5 and 13.6 using Pencil Beam Convolution (PBC) Algorithm 11.0.31(Radiation therapy treatment planning system)

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-2016-RN-00064-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-01-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00064-1
  • 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 anomaly in pbc algorithm 11.0.31 affects eclipse versions 11, 13, 13.5 and 13.6, for arcs consisting of more than 100 segments causing eclipse to display a dose distribution that does not correspond to the calculated monitor units, which may lead to an overdose. the discrepancy is easily detectable when a phantom is used to verify the treatment plan, as advised in the user documentation. the discrepancy between the displayed dose distribution and mus increases with the number of segments above 100. when the arc has few segments above 100, the discrepancy is smaller and more difficult to detect. as the number of segments increases above 100, the discrepancy between the displayed dose and the actual dose becomes more pronounced. when an arc is comprised of significantly more than 100 segments, the arc plan will not display mu, and the arc treatment plan will become invalid and cause the treatment to be blocked. varian has not received any report of mistreatment due to this issue.
  • Action
    Varian Medical Systems is currently investigating a permanent solution for this issue. In the interim, users are advised to NOT USE Eclipse version 11, 13, 13.5, or 13.6 with PBC 11.0.31 algorithm for conventional arc field dose calculation. Varian recommends use of the Eclipse Anisotropic Analytical Algorithm (AAA) or Acuros XB advanced dose calculation algorithm for conventional arc field dose calculation. Users can verify whether a plan generated by Eclipse version 11, 13, 13.5 or 13.6 using PBC 11.0.31 exceeds the 100 segment limit for a given field by reviewing the calculation log files. The affected fields should be evaluated by re-calculating the plan with either: AAA, Acuros XB or PBC 10.0.28 dose calculation algorithms. For conformal arc plans, fields can also be evaluated in the properties of the dynamic MLC.

Device

Eclipse Treatment Planning System v 11, 13.0, 13.5 and 13.6 using Pencil Beam Convolution (PBC) A...
  • Model / Serial
    Eclipse Treatment Planning System v 11, 13.0, 13.5 and 13.6 using Pencil Beam Convolution (PBC) Algorithm 11.0.31(Radiation therapy treatment planning system)Product Code: 48Multiple Serial Numbers affectedARTG Number : 119983
  • Product Classification
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd