Events

Recall of Mammomat Inspiration (diagnostic mammography X-Ray 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-00893-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00893-1
  • 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
    An addendum of the operating manual has been released to provide more detailed description about the emergency release of the compression unit in case of system error or a power failure.
  • Action
    The sponsor is providing an update to the Instructions for Use (IFU).

Device

Mammomat Inspiration (diagnostic mammography X-Ray system)
  • Model / Serial
    Mammomat Inspiration (diagnostic mammography X-Ray system)ARTG Number: 144223
  • Manufacturer
    Siemens Ltd

Manufacturer

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