Events

Recall of Mammomat Inspiration System with software version VB30 and Biopsy functionality

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare Pty 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-2017-RN-00071-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00071-1
  • 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
    Siemens has become aware of potential errors that may occur while performing a biopsy. the system may freeze and biopsy functionality may become unavailable in the following situations:- drop of the compression force, e.G. this may occur due to a patient's sudden movement during the active targeting phase- use of the inversion tool while the scout image is active during the targeting phase.As a result of system freeze, the biopsy may have to be repeated.
  • Action
    Siemens will release a software update to resolve the issue. Siemens service engineer will contact affected customers to schedule the software update. In the interim, Siemens is advising users to follow these instructions: 1) Do not close the error message window when it is displayed. Instead, cancel the active target before closing the window. Users can start all over after the completion of these steps. 2) Users are advised not to use the inversion tool while the scout image is active. In the event of a system freeze, the acquisition workplace must be rebooted.

Device

Mammomat Inspiration System with software version VB30 and Biopsy functionality
  • Model / Serial
    Mammomat Inspiration System with software version VB30 and Biopsy functionalityCatalogue Number: 10140000 (with software version VB30 and with a Biopsy option)ARTG Number: 274541
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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