Events

Recall of MAGNETOM Aera (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-2014-RN-00515-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00515-1
  • 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
    It has been identified that an incomplete set of operator manuals has been supplied for the following coils and options for the magnetom aera system:· 4 ch bi breast· 16 ch ai breast· breast 18· 2-4-8 ch breast coil sentinelle· mr-elastography optionthe instructions and the safety information that is missing from the manuals cannot be consulted when needed.
  • Action
    Updated Operator Manuals will be supplied to customers with the customer letter or will be sent soon by courier. Users are advised to study the missing manuals provided, especially the safety information included in the manuals.

Device

MAGNETOM Aera (Full Body MRI System)
  • Model / Serial
    MAGNETOM Aera (Full Body MRI System)Catalogue Number: 10432914ARTG Number: 98485
  • Manufacturer
    Siemens Ltd

Manufacturer

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