Events

Recall of TomoTherapy High Performance Patient Couch

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-2017-RN-01458-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01458-1
  • 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
    Emergo australia has been made aware that under certain circumstances when using the tomotherapy high-performance patient couch, an unintended descent may be experienced when the user initiates patient couch motion in the z-direction (up or down) for patient setup or patient unload using the keypad or pcp.This action was undertaken prior to consultation with the tga.
  • Action
    The manufacturer, Accuray, will be in contact with affected users to arrange for installation of a software update and replacement of cables within the couch subsystem.

Device

TomoTherapy High Performance Patient Couch

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia