Events

Recall of Philips Ingenia 1.5T and 3.0T MR Systems Shipped between 2nd December 2013 and 7th March 2014.

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-00786-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-07-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00786-1
  • 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
    In the ingenia rear cover set magnetic m10 nuts (four) were erroneously supplied to the installer instead of non- magnetic a4 stainless steel nuts.
  • Action
    All Philips installation and service engineers have been alerted to this hazard. A Field Change Order with reference FCO 78100432 is being released directing Philips field service engineers to inspect the Ingenia rear cover set nuts and replace them if needed with non-magnetic stainless steel nuts. Philips is instructing the customers to contact, if required with regard to this program, quoting the reference FCO 78100432. This action has been closed-out on 04/08/2016.

Device

Philips Ingenia 1.5T and 3.0T MR Systems Shipped between 2nd December 2013 and 7th March 2014.

Manufacturer

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