Events

Recall of DX-D 600 X-ray System, Versions below 3.6

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by AGFA HealthCare 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-2014-RN-01247-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-11-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01247-1
  • 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 unit is equipped with safety measures to ensure no movement can occur without user interaction. however, a customer complaint reported that during normal movement’s isolated cases of unintended overhead tube crane acceleration occurred.
  • Action
    Users are advised that in the case of an accelerated movement, release the button/pedal immediately to stop the unit and notify their Agfa HealthCare service contact at once. Agfa Healthcare will be upgrading all full automatic and semi-automatic DX-D 600 devices to Version 3.6 to eliminate this issue. This action has been closed-out on 12/08/2016.

Device

DX-D 600 X-ray System, Versions below 3.6

Manufacturer

AGFA HealthCare Australia