Events

Recall of HexaPOD evo RT System with HexaPOD evo Module

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-2018-RN-00560-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-05-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00560-1
  • 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
    Upon completion of a 6d workflow, the hexapod evo module may be in a tilted state, if it is moved to the position used for 3d (non-iguide) treatments. in a subsequent 3d workflow, a possible incorrect position of the patient, due to a tilt of the hexapod, may be difficult to detect without verification. this description is not relevant for an iguide workflow (6d). the problem occurs only when a user switches from a 6d to a 3d workflow without iguide.
  • Action
    Elekta is advising customers the correct position will be reached when the command to move the HexaPOD to the predefined 3D position is repeated. Users must perform this additional step without a patient on the HexaPOD after each change from the 6D workflow to the 3D workflow. Please refer to the respective User Manual for details how to initiate the movement. The manufacturer is currently investigating solutions to rectify this issue. Once available, Elekta will contact users to coordinate the required actions.

Device

HexaPOD evo RT System with HexaPOD evo Module
  • Model / Serial
    HexaPOD evo RT System with HexaPOD evo ModuleARTG Number:187340(Elekta Pty Ltd - Table, radiation therapy, x-ray, powered)
  • Product Classification
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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