Events

Recall of Philips Ingenia 1.5T and Ingenia 3.0T MR systems with Ingenia MR-OR solution

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-01595-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01595-1
  • 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
    There is an electrical component called mr-or laser control board in the flextrak or trolley, under the interface adapter. in production, two mr-or laser control boards have been found where the laser control board has been assembled incorrectly, leading to insufficient isolation distance. hence, there is a possibility that a patient or user may be exposed to a very small, level of touch current. in practice, the current is so low that it may not even be noticed.
  • Action
    Philips has revised the design of the control board and is sending out service engineers to install the revised boards.

Device

Philips Ingenia 1.5T and Ingenia 3.0T MR systems with Ingenia MR-OR solution

Manufacturer

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