Events

Recall of DigitalDiagnost (Digital diagnostic 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-2012-RN-01224-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-12-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01224-1
  • 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
    Philips previously notified owners of digitaldiagnost systems with software releases 3.0.1 and 3.0.2, that a new software release 3.0.3 would be installed on their systems (without due consultation with the tga). however, software release 3.0.3 contained a defect that may result in the incorrect placement of the electronic marker (left/right) indicating the patient side of an image is rotated. software release 3.0.4 corrects this defect in release 3.0.3, and it will be installed on affected systems in place of release 3.0.3.When the operator for a wall stand view selects an “image rotation” different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. when the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
  • Action
    Update to system software

Device

DigitalDiagnost (Digital diagnostic X-Ray System).
  • Model / Serial
    DigitalDiagnost (Digital diagnostic X-Ray System). All systems with Eleva software version 3.0.xARTG Number: 117662
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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