Events

Recall of iGUIDE with software version 2.2.0 (used with HexPOD evo RT System, used for accurate patient positioning during radiation therapy treatment)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Elekta 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-01116-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01116-1
  • 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
    Iguide monitors if the hexapod is in the pre-defined 3d position. if it is not in this position an inhibit is set. for 3d treatments there is no iguide interlock check possible. in the event of a malfunction of the interlock system an inhibit in iguide may not lead to an external inhibit on the linac. there is the potential for unrecognised incorrect position of the treatment couch in 3d workflow, i.E. the hexapod has not moved fully to the 3d position.
  • Action
    Elekta is advising user that if users do not intend to use iGUIDE for patient positioning, make sure the HexaPOD is at its pre-defined 3D position before treatment. The 3D position is confirmed in the iGUIDE login screen (no inhibit icon) or in the iGUIDE System Overview. In addition the External Inhibit LED at the Enable Switch Board must be off. It is recommended to perform the Interlock Check in the iGUIDE software on a daily basis. This information has been included in the Instructions For Use (IFU). This action has been closed-out on 09/05/2017.

Device

iGUIDE with software version 2.2.0 (used with HexPOD evo RT System, used for accurate patient pos...
  • Model / Serial
    iGUIDE with software version 2.2.0 (used with HexPOD evo RT System, used for accurate patient positioning during radiation therapy treatment) ARTG Number: 187340
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    DHTGA