Events

Recall of DigitalDiagnost - EasyUpgrade DR (Diagnostic digital 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-2013-RN-00910-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00910-1
  • 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 mirror icon on the bottom of each image could be misinterpreted as a right lead marker for side indication if the image is mirrored within a pacs system.The misinterpretation of the mirror icon to be a patient right side indication could potentially lead to a misdiagnosis.
  • Action
    Clinical staff should follow the Instructions for Use and use lead letters to indicate body orientation of the patient or equivalent electronic markers to provide Left/Right indicators, during all x-ray image acquisitions. Philips is advising users that a software and hardware upgrade will be performed to replace the mirror icon. Philips will also provide updated Instructions for Use for the work spot and the system.

Device

DigitalDiagnost - EasyUpgrade DR (Diagnostic digital x-ray system)
  • Model / Serial
    DigitalDiagnost - EasyUpgrade DR (Diagnostic digital x-ray system)system code 712086ARTG Number: 117662
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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