Events

Recall of Achieva 3.0T and Ingenia 3.0T MR Systems with passive shielding in the rear wall

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-01389-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-10-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01389-1
  • 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
    For the achieva 3.0t and ingenia 3.0t mr systems on sites with rear wall passive shielding, the thickness and location of shielding material must be installed according to requirements provided by philips. in cases where the requirements are not followed, the distance between the passive shielding rear wall and magnet could be insufficient. an insufficient distance leads to stronger attraction forces between the magnet and the passive shielding, which may lead to shearing of the magnet vibration pads. in a worst case scenario there may be displacement of the magnet, which could possibly result in harm (crushing risk) to persons inside the mr room and located between the magnet and passive shielding wall. to date there has been one overseas report of the magnet shifting with no harm to users or patients. displacement of a magnet can also result in image quality issues and mechanical fitting problems with the table. these functional issues affect the clinical usage of the mr system.
  • Action
    Philips is advising customers that if the distance between magnet covers and finished rear wall is less than 1.3m, to contact Philips. In addition, Philips Field Service Engineers will be visiting all sites and checking this distance. If action is required, Philips will, as appropriate, replace the magnetic vibration pads and/or install seismic brackets. Depending on the circumstances, it may be advised that further clinical use of the MR system should not occur until after the installation corrections have been completed.

Device

Achieva 3.0T and Ingenia 3.0T MR Systems with passive shielding in the rear wall

Manufacturer

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