Events

Recall of All Magnetom MRI systems with superconductive magnets

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare Pty 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-2015-RN-01251-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01251-1
  • 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 some cases the quench lines of some superconducting magnets may not have been properly installed.Quench lines are installed to vent helium gas in the event of a quench (i.E., sudden loss of superconductivity when the temperature is raised). in the unlikely event that a quench were to occur, a damaged/inappropriately installed quench line could lead to a displacement of oxygen, cold burns and/or could pose a risk to users, patients or others if the helium gas is vented to a closed area inside a building.
  • Action
    The sponsor is advising users to contact their contract quench line installer (Siemens or third party) to perform a quench line inspection. In the interim, users are reminded that it is important to follow the guidelines outlined in the System Owner Manual, including ensuring that they have an emergency plan in place in the event helium gas escapes into the magnet room or other rooms. This action has been closed-out on 04/05/2017.

Device

All Magnetom MRI systems with superconductive magnets
  • Model / Serial
    All Magnetom MRI systems with superconductive magnetsVarious System NamesCatalogue Numbers: 10433372, 10432914, 7391167, 10849579, 10018165, 10352127, 10836666, 10836618, 10849582, 10849583, 10432915, 10849580, 7104719, 10655588, 7104594, 106557, 10018223, 7387074, 10018221 and 10276755ARTG Numbers: 98319, 144221, 98485, 154128 and 188470
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA