Events

Recall of iPlan RT / iPlan RT Dose Radiation Treatment Planning Software used in combination with a localiser and one of the positioning solutions Target Positioner, ExacTrac v.4.5 or v.5.x, ExacTrac Vero (versions 2.1, 3.0, 3.1, 3.1.1, 3.2.0, 3.2.1)

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-2014-RN-01293-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-12-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01293-1
  • 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
    Incorrect patient positioning at the linac might occur, if all of the following conditions are met:1. at least two different ct datasets are being used and have been both localized and fused toeach other in the same treatment plan.2. the latest ct scan used with the localizer is not assigned as both reference set and alignmentset (for definitions, see the appendix).3. patients are positioned at the linac using one of the following positioning solutions:- target positioner- exactrac v.4.5 or v.5.X- exactrac vero (from v.2.1 up to v.3.2.1)the magnitude of potentially incorrect patient positioning is given by the difference in patient position inside the localizer during the two ct scans, one of which was assigned to the reference set and the other to the alignment set.
  • Action
    1) Brainlab will provide existing potentially affected iPlan RT / iPlan RT Dose customers with this product notification information. 2) 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. 3) Brainlab will refine the instructions for use of the iPlan RT treatment planning software in regard to implications of Alignment Set and Reference Set selections and will provide this user guide update to existing affected customers together with the software update. This action has been closed-out on 22/08/2016.

Device

iPlan RT / iPlan RT Dose Radiation Treatment Planning Software used in combination with a localis...
  • Model / Serial
    iPlan RT / iPlan RT Dose Radiation Treatment Planning Software used in combination with a localiser and one of the positioning solutions Target Positioner, ExacTrac v.4.5 or v.5.x, ExacTrac Vero (versions 2.1, 3.0, 3.1, 3.1.1, 3.2.0, 3.2.1)ARTG Number: 121114
  • Product Classification
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd