Events

Recall of Magnetom Spectra 3.0 T System (MRI system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens 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-00023-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-01-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00023-1
  • 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
    Due to an isolated production issue, the body coil in the mri may possibly be fatigued after certain months of usage. this fatigue may potentially lead to the risk of overheating during delivery of rf energy due to underestimated specific absorption rate (sar) in extremely rare conditions for head, neck and shoulder examinations. siemens is not currently aware of any incidents related to this issue. however, the risk of overheating which may include tissue damage cannot be totally excluded, although the possibility of occurrence for serious injury is extremely low according to siemens' risk assessment.
  • Action
    Users are advised to undertake extra precautions during head, neck and shoulder scans ie, to advise patients to immediately communicate uncomfortable heating sensations so that the scan can be stopped. Body coils will be replaced as soon as possible for the systems which have been identified as having a slight beginning of aging. For the remaining potentially affected systems, tune up measurements and QA checks will be performed by the end of February 2014 to readjust the system if required to eliminate any immediate risk. All potentially affected body coils will be replaced by the end of May 2014.

Device

Magnetom Spectra 3.0 T System (MRI system)
  • Model / Serial
    Magnetom Spectra 3.0 T System (MRI system)Catalogue number: 10655588Serial numbers: 56031, 56029, 56019 & 56017ARTG number: 154128
  • Manufacturer
    Siemens Ltd

Manufacturer

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