Events

Recall of iPlan RT Dose, versions 4.0 and 4.1 (including all subversions)(Radiation Treatment Planning Software)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Brainlab Australia 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-2015-RN-00616-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-07-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00616-1
  • 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 automatic monitor units (mu) calculation (normalisation) might be incorrect in the brainlab iplan rt dose versions 4.0 and 4.1 if all of the following conditions are met: - several ptvs are planned in the treatment plan, and - at least one treatment group or treatment element is locked to prevent further modification, and - for any ptv with a locked treatment group or with at least one locked treatment element assigned the dose at the 50% volume constraint point deviates more than 5% from the actual dose at 50% volume.If the mu calculation is refreshed, the software will always normalise the dose of the ptvs, which do not have a locked treatment group or treatment element assigned, to the 50% volume constraint point. other constraint points for the ptvs will be disregarded even if a constraint point is set “hard constraint” and therefore the intended prescription will not be automatically fulfilled for ptvs without a locked treatment group or locked treatment element.
  • Action
    Brainlab will provide a software solution to prevent the described scenario from occurring. Brainlab will actively contact affected customers starting January 2016 to schedule the update. This action has been closed-out on 12/08/2016.

Device

iPlan RT Dose, versions 4.0 and 4.1 (including all subversions)(Radiation Treatment Planning Soft...

Manufacturer

Brainlab Australia Pty Ltd