Events

Recall of MobileDiagnost wDR 1 and 2(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-2015-RN-00524-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00524-1
  • 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
    When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behaviour may not be possible. the system can be stopped by releasing the drive handle. proper behaviour is re-enabled when the system is rebooted. the hazard associated to this defect is the potential of a collision.
  • Action
    Philips is preparing a field action kit, which will allow a Philips Service Engineer to replace the existing arrestor strap by a new arrestor with higher resistivity. This will reduce the electromagnetic pulse to a level, which is safe to not disturb the electronics. Users are advised not to try to correct unintended movement using the controls on the drive handle. Instead, stop the system immediately by releasing the drive handle entirely. Alternatively, the emergency button can be pressed. Take special care when the system crosses metal strips or plates on the floor or enters an elevator, as these are situations where electrostatic discharge is likely to occur. This action has been closed-out on 18/08/2016.

Device

MobileDiagnost wDR 1 and 2(Mobile digital x-ray imaging system)

Manufacturer

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