Events

Recall of DuraDiagnost X-ray System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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-2015-RN-00089-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-01-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00089-1
  • 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
    During recent evaluations of the philips duradiagnost x-ray system, philips have identified a potential issue that may affect the performance of the equipment under certain conditions. 1) if all six t-nuts which are used to mount the x-ray tube arm base to the carriage were not properly assembled, the tube arm assembly could fall. 2) if all eight t-nuts which are used to mount the wall stand detector carrier box and base were not properly assembled, the wall stand detector carrier assembly could fall. 3) if all eight t-nuts which are used to mount the table base and table top floating frame were not properly assembled, the table top could be floating.
  • Action
    A Philips Service Engineer will conduct an inspection to determine if the equipment is affected by this issue. If it is determined that the tube arm and wall stand fixture are not in the correct position the equipment should cease to be used until the tube arm and wall stand fixture have been replaced. A new tube arm and wall stand fixing structure that is designed to prevent this hazard if the tube arm or Wall stand is incorrectly reinstalled in the future will be fitted. This action has been closed-out on 18/07/2016.

Device

DuraDiagnost X-ray System

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA