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-01037-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01037-1
  • 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 footplate of the patient carriage can be fixed in a vertical position with a hook. the hook may fail when moving the carriage, or when the operator does not secure it correctly upon moving the plate up, and the footplate can fall down.
  • Action
    Philips Healthcare is providing work around instructions and will be replacing the hook with a new design to permanently correct the issue.

Device

DigitalDiagnost (Digital Diagnostic X-ray System)
  • Model / Serial
    DigitalDiagnost (Digital Diagnostic X-ray System)Serial Number range: 00 000 00 to 09 000 543ARTG Number: 117662
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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