Events

Recall of Flex Large 4 Coil for MAGNETOM Skyra, Verio, Spectra and Biograph mMR (Full body 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-2012-RN-00949-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-09-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00949-1
  • 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
    When positioning the coil off centre in the left direction as it is used, for example, a hip and shoulder imaging and, in addition at an off centre position with respect to the head-foot direction, the coil can heat up on the area of the electronic housing (white plastic lids).To be more precise, heating may occur if each of the following conditions applies at the same time:- coil positioned off-center in head-foot direction by more than 5cm- coil at side position- application of higher rf power over several minutes.In that position, the surface temperature may well exceed temperatures defined by regulatory standards and may cause local burns to the patient.
  • Action
    Siemens is providing work around instructions for users to follow.

Device

Flex Large 4 Coil for MAGNETOM Skyra, Verio, Spectra and Biograph mMR (Full body MRI System)
  • Model / Serial
    Flex Large 4 Coil for MAGNETOM Skyra, Verio, Spectra and Biograph mMR (Full body MRI System)ARTG Number: 98485
  • Manufacturer
    Siemens Ltd

Manufacturer

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