Events

Recall of Stereo Biopsy Device used with Mammomat Inspiration Mammography SystemMaterial number: 10140000 (Mammomat Inspiration)

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-01040-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-09-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01040-1
  • 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
    The stereo biopsy devices for mammomat inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. the pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. the needle positioning device may move even with the safety switch being set sideward. if this occurs with the needle being already inserted, it could lead to an unintentional patient injury.
  • Action
    Customers are advised that in case the needle holder moves unintentionally to press the emergency stop. Siemens is recommending inspection of the safety switch before every biopsy until the problem is solved. Siemens is preparing a modification of the safety switch that will resolve this potential malfunction. The field modification will be available beginning of October. This action has been closed-out on 07/06/2016.

Device

Stereo Biopsy Device used with Mammomat Inspiration Mammography SystemMaterial number: 10140000 (...
  • Model / Serial
    Stereo Biopsy Device used with Mammomat Inspiration Mammography SystemMaterial number: 10140000 (Mammomat Inspiration) Serial numbers: 1541, 2082ARTG number: 144223
  • Manufacturer
    Siemens Ltd

Manufacturer

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