Events

Recall of MobileDiagnost wDR (digital x-ray system)All units affected

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-00762-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00762-1
  • 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
    Under the following conditions the system may execute an unintended movement and injure the operator or bystander:- strain gauges fail to reach the specified life time- operator requests movement by pressing the dead man handle switch and pushing or pulling the handle bar- operator/bystander standing close to the device.
  • Action
    End users are advised to release the drive handle (dead man switch) in the event of unintended movement. Philips will be updating the strain gauges of the MobileDiagnost wDR. This action has been closed-out on 11/02/2016.

Device

MobileDiagnost wDR (digital x-ray system)All units affected

Manufacturer

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