Events

Recall of MobileDiagnost wDR (Mobile digital 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-00959-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-09-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00959-1
  • 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
    If the system drives over insulated flooring or carpeting and then over an un-insulated (earthed) point or electrically grounded section, an electrostatic discharge (esd) spark can cause the system’s digital motion control (dmc) board to malfunction, resulting in unintended movement of the system e.G., an increase in speed or a change of direction. the hazard associated to this defect is the potential of a collision with the system.
  • Action
    Users are provided with temporary workaround solutions to prevent the failure mode from occurring and if it occurs to stop the system immediately by releasing the drive handle entirely or by pressing the emergency button. A Philips Service Engineer will contact the customer as soon as the Field Action Kit is ready to be implemented that will allow to electrically isolate the DMC board from its frame by replacing the existing stainless steel bolts and washers with plastic spacers and nylon screws. This action has been closed-out on 1/06/2016.

Device

MobileDiagnost wDR (Mobile digital x-ray imaging system)

Manufacturer

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