Events

Recall of DigitalDiagnost (Digital diagnostic X-Ray System) with software version 2.0.2 and 2.0.2SP1

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-01208-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-12-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01208-1
  • 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 affected digitaldiagnost systems that software release 2.1.3 would be installed on the systems to modify the appearance of a mirror icon. however, software release 2.1.3 contained a defect that may result in the incorrect placement of the electronic marker (left/right) indicating the patient side if an image is rotated.Software release 2.1.4 addresses both the original & new issue, & it will be installed on affected systems in place of release 2.1.3. if software release 2.1.3 has already been installed on a system, it will be replaced with release 2.1.4.With digitaldiagnost r 2.0.2 a mirrored “r in a circle” is burnt into the image (if mirrored) in the lower right corner of the image. when such an image is mirrored back inside the pacs system, an unmirrored “r in a circle” appears in the lower left corner. this can be mistaken for a “right patient side” marker, although this can appear on the left patient side.
  • Action
    Philips Healthcare will be installing a software update to address the identified issue.

Device

DigitalDiagnost (Digital diagnostic X-Ray System) with software version 2.0.2 and 2.0.2SP1
  • Model / Serial
    DigitalDiagnost (Digital diagnostic X-Ray System) with software version 2.0.2 and 2.0.2SP1All products with software release 2.0.2 and 2.0.2SP1ARTG Number: 117662
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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