Events

Recall of Hexapod iGUIDE 2.1, iGUIDE 2.2

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-00636-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-05-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00636-1
  • 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 manufacturer has identified a software issue which may lead to incorrect patient positioning during treatment. in a specific scenario the software may prompt the user several times to move the hexapod to its drive (*start) position. if the user follows this request the hexapod will move to drive (*start). in a consecutive step iguide shows hints to move the couch top with the precise table back to the initial imaging position. however, this position is reached only with a coarse movement. the final fine adjustment move, executed by the hexapod, is missing. the coarsely reached imaging position becomes the new registered position for the actual position error correction (pec) movement to the target position. a theoretical additional error of max. ± 2 mm in three dimensions, in respect to the true target position, can occur due to the missing fine movement.
  • Action
    Electa advises users to avoid imaging in the PARK (*LOAD) position. If the user has performed imaging when the HexaPOD is not in the DRIVE (START*) position, cancel all move to DRIVE (START*) requests. Thus the HexaPOD remains in the imaging position. If the user then applies the PEC the HexaPOD will reach the target in the specified accuracy. The movement to the target will be a combination of Precise Table and HexaPOD moves. In case of any doubts perform a verification scan. A software update which will correct the behaviour of the affected iGUIDE versions 2.1 and 2.2 will be provided to the affected customers free of charge as soon as it becomes available.

Device

Hexapod iGUIDE 2.1, iGUIDE 2.2

Manufacturer

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