Events

Recall of DigitalDiagnost Release 4.0.0. and 4.0.1

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-2015-RN-00072-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-01-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00072-1
  • 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 system is designed to emit an acoustic signal (beep) upon termination of an exposure. however, if the system has been powered on for more than 54 hours, the beep will no longer be emitted. if the system does not provide the expected acoustic signal upon the completion of an exposure, the operator may be unsure that the exposure was correctly obtained, which may result in the decision to repeat an exposure resulting in unnecessary radiation being administered to the patient.Until the system software is upgraded to release 4.0.2 to eliminate the potential loss of the acoustic signal upon termination of an exposure, philips recommends that users reboot the system every two days or less.
  • Action
    Customers are alerted to this issue and provided with a workaround until a permanent software fix can be rolled out. This action has been closed-out on 08/08/2016.

Device

DigitalDiagnost Release 4.0.0. and 4.0.1

Manufacturer

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