Events

Recall of DuraDiagnost X-ray systems

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-2016-RN-00925-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00925-1
  • 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
    Duradiagnost systems provide an audible exposure termination signal (beep) through the speaker integrated into the monitor. however, buttons or keys on the monitor allow the user to turn the volume setting down to “0”, in which case the beep will not be heard at the conclusion of an exposure. note that the current volume setting is displayed when the buttons or keys are depressed. if the monitor volume is set to “0”, the absence of an audible exposure termination signal may lead the operator to assume that an exposure was not performed correctly and therefore unnecessarily repeat the patient exposure.
  • Action
    Philips is advising users to check the volume of the monitor to ensure it is not set to '0'. Philips will be implementing a software upgrade as a permanent correction.

Device

DuraDiagnost X-ray systems

Manufacturer

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