Events

Recall of iPlan RT Dose version 4.0 and 4.1 (including all subversions) (Radiation therapy treatment planning system)

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-2013-RN-00339-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00339-1
  • 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
    Iplan rt dose version 4.0 and 4.1 might not correctly refresh the dose calculation after certain mlc shape modifications if all of the following conditions are met:- the modifications are performed for a dynamic conformal arc, and- the jaw positions are defined manually, and- the dose display (e.G. isodose lines) is turned on, or if the dose has already been calculated and the dose display is turned on again after the mlc shape was modified. the effect may occur for the following modifications of the mlc shape: - the mlc margin of the arc is modified- the mlc shape is modified in the beam’s eye view (bev) in a way that also changes the mlc shapes of neighbouring segments of the arc1- the leaf adaption is modified (inline/average/outline)- the modified mlc shapes in the bev are resetthe dose calculation is not refreshed in the physician’s review and physicist’s verification tasks or when generating the printout or exporting the plan.
  • Action
    Brainlab is providing work around instructions and is developing a software update to permanently correct the problem.

Device

iPlan RT Dose version 4.0 and 4.1 (including all subversions) (Radiation therapy treatment planni...
  • Model / Serial
    iPlan RT Dose version 4.0 and 4.1 (including all subversions) (Radiation therapy treatment planning system)ARTG Number: 121114
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd