Events

Recall of Biograph mCT and Biograph mCT Flow systems running VG50A software and equipped with the Adaptive 3D Intervention option

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-01243-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-11-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01243-1
  • 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 identified a potential malfunction that may cause a display freeze during ct interventional procedures. the user interface may lock-up when performing an adaptive 3d interventional procedure when the "auto save at last displayed images as key images" is enabled. when the issue occurs, normal interaction with the system is no longer possible and no error messages are displayed. therefore the end-user and/or interventionalist may not know that the system has stopped interacting and continue wiht the interventional procedure.
  • Action
    Siemens is advising their customers to reconfigure the system Storage to deactivate "Auto save at last displayed images as key images". A software update will be implemented to correct the problem. This action has been closed-out on 18/03/2016.

Device

Biograph mCT and Biograph mCT Flow systems running VG50A software and equipped with the Adaptive ...
  • Model / Serial
    Biograph mCT and Biograph mCT Flow systems running VG50A software and equipped with the Adaptive 3D Intervention optionSoftware version: VG50AARTG number: 144218
  • Manufacturer
    Siemens Ltd

Manufacturer

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