Events

Recall of DuraDiagnost 3.0/4.0 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-00424-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00424-1
  • 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 system is designed to emit an acoustic signal (beep) upon termination of an exposure. however, if the system has been powered on for more than 12 hours, the system will no longer emit this signal.
  • Action
    Philips recommends that the system is rebooted at least every 11 hours until the software is upgraded. A Philips service engineer will contact the customers to implement the software upgrade to release 02.3400.015. This action has been closed-out on 17/08/2016.

Device

DuraDiagnost 3.0/4.0 X-ray system
  • Model / Serial
    DuraDiagnost 3.0/4.0 X-ray systemProduct numbers 712211, 712214Multiple lot numbers ARTG Number: 207424
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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