Events

Recall of iPlan RT, iPlan RT Dose and BrainSCANAll Software versions

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-2016-RN-01641-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-12-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01641-1
  • 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
    Brainlab has identified an issue where there is the possibility of a potential inaccurate dose calculation for small mlc-shaped fields when using the pencil beam algorithm. the pencil beam algorithm refers to beam data which is acquired by performing dose measurements for mlc fields at predefined field sizes and which are stored using the iplan rt physics administration / brainscan beam profile editor. due to an inaccurate implementation in the brainlab radiation treatment planning software, the interpolation between two measured values is less accurate a) the smaller the field and;b) the further away the equivalent field size is from the measured value. for certain treatment setups, this leads to the effect that an insufficient amount of monitor units (mu) is calculated and that consequently the delivered dose is lower than the planned dose. for clarity, the delivered dose does not exceed the planned dose due to the described issue.
  • Action
    As a workaround, to reduce the described dose deviation to less than 2% using the Pencil Beam algorithm in iPlan RT 4.5.x Brainlab recommends to modify the machine profile following the instructions outlined in the Appendix provided. For all Brainlab treatment planning systems, as recommended by Brainlab, perform proper pre-treatment quality assurance for every treatment plan. Independent calculation of the dose using 3rd party QA Software or dose measurements inside a phantom is suitable to judge the accuracy of the dose calculation. Refer to the Brainlab Physics Technical Reference Guide for details.

Device

iPlan RT, iPlan RT Dose and BrainSCANAll Software versions
  • Model / Serial
    iPlan RT, iPlan RT Dose and BrainSCANAll Software versionsARTG Number: 121114
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd