Events

Recall of HexaPOD evo RT Couchtop (X-ray powered radiation therapy table)

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-00468-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00468-1
  • 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
    If the screws that secure the hexapod evo rt couchtop are not adequately tightened during installation, they may loosen over time. this condition has the following possible impacts: - there may be incorrect patient repositioning if the hexapod evo rt couchtop is moved.- the hexapod evo rt couchtop could tip when a patient is in a highly extended position (which could be the case in treatments of the lower body half).
  • Action
    Elekta is advising their customers to check each screw to determine if it is loose. If any screw is loose the HexPOD evo RT system must be taken out of service and the service engineer responsible for the equipment should be contacted. The service engineer will tighten the screws to 20 Nm before the couchtop can be used.

Device

HexaPOD evo RT Couchtop (X-ray powered radiation therapy table)
  • Model / Serial
    HexaPOD evo RT Couchtop (X-ray powered radiation therapy table)ARTG Number: 187340
  • Product Classification
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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