Events

Recall of DuraDiagnost X-ray systems with software version 4.0.2, 4.0.3 and 4.0.4

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-00675-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00675-1
  • 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
    A firmware anomaly inside the detector (px4343rg) can cause the detector to appear ready for acquisition on very short time intervals while it actually is not ready. this may result in an inadequate acquisition of the x-ray image. if a corrupted image cannot be used for its clinical purpose, it may be necessary to retake with additional exposure.
  • Action
    Philips is providing a software upgrade to version 4.0.5 to permanently correct this issue. This action has been closed-out on 24/05/2017.

Device

DuraDiagnost X-ray systems with software version 4.0.2, 4.0.3 and 4.0.4

Manufacturer

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