Events

Recall of MobileDiagnost wDR Rel1 and 2 (general purpose mobile digital x-ray 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-2016-RN-00351-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00351-1
  • 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 power plug, which has been supplied with the system, is not according to the requirements in australia (as/nzs 3115:2000). the pins of the plug can be touched when the plug is not inserted completely into the mains outlet, potentially exposing a person to electrical shock.
  • Action
    Philips is advising users to be aware of this issue and will be replacing the plugs as a permanent fix. This action has been closed-out on 12/05/2017.

Device

MobileDiagnost wDR Rel1 and 2 (general purpose mobile digital x-ray system)

Manufacturer

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