Events

Recall of MobileDiagnost wDR (mobile x-ray unit)

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-2013-RN-00034-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-01-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00034-1
  • 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
    Due to a potential electrical defect, encoder defect or software error the movement speed regulation of the mobilediagnost wdr does not work as intended. the device may move with increasing speed and/or in the wrong direction for up to 1.5 seconds after releasing the dead man switch (handle bar). additionally, there is the potential for batteries to overheat.
  • Action
    Philips is advising customers to activate the emergency switch in the event of unintended movement which will immediately stop the MobileDiagnost wDR. Once a corrective action has been determined Philips will implement a fix to stop unintended movement. In addition, Philips will install a battery thermostat to the device.

Device

MobileDiagnost wDR (mobile x-ray unit)

Manufacturer

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