Events

Recall of HexaPOD evo RT Systems running iGUIDE 2.0.0 - 2.0.2 (used for accurate patient positioning within a radiation therapy treatment environment)

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-2014-RN-00612-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-06-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00612-1
  • 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 iguide key allows to the treatment of patients without using the hexapod evo rt system. when users turn the iguide key to the off position; the external inhibit signal is overridden and the iguide software closes any open fractions and logs off (login appears). in some circumstances, a bug in the iguide software prevents the iguide software from logging off. the iguide software looks like it can be used for positioning, but it is no longer running correctly. even when users turn the iguide key back to the on position, it will not set the external inhibit signal or alert them if the position has changed (ie, position guard is inactive). this problem can lead to clinical mistreatment if the user assumes that the iguide software is running correctly. the iguide software will not set the external inhibit signal or notify the user in case of incorrect positioning or movements.
  • Action
    Users should only use the iGUIDE software when the key is in the on position and the Position Guard is active. Users are advised to restart the workstation if any error occurs to ensure the software is running properly. A software update will be implemented on all affected systems that corrects the behaviour of the iGUIDE software. This action has been closed-out on 11/02/2016.

Device

HexaPOD evo RT Systems running iGUIDE 2.0.0 - 2.0.2 (used for accurate patient positioning within...
  • Model / Serial
    HexaPOD evo RT Systems running iGUIDE 2.0.0 - 2.0.2 (used for accurate patient positioning within a radiation therapy treatment environment)ARTG Number: 187340
  • Product Classification
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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