Events

Recall of MobileDiagnost wDR (Mobile x-ray imaging 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-2014-RN-00565-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00565-1
  • 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 mobilediagnost wdr executes an unintended exposure under the following specific error conditions:- the hand switch is erroneously stuck in pressed position, while the system is switched off, - the system is powered up with the hand switch in that erroneous condition, - the user logs in, selects a patient for examination, gets a green ready light in, - the examination context, if the tube arm is then moved out of the zero position, the system is doing an exposure.The hazard associated to this defect is one single unintended exposure with the parameters configured previously by the user in the last examination. no continuous radiation is emitted in any case.
  • Action
    Philips plans to update the software Philips Service Engineer will contact customers as soon as the Field Action Kit is ready to be implemented. The system can be used according to the Instruction for Use without restrictions. This action has been closed-out on 10/02/2016.

Device

MobileDiagnost wDR (Mobile x-ray imaging system)

Manufacturer

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