Events

Recall of Biograph mCT Systems with VG40 Software (Diagnostic imaging 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-2013-RN-00357-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00357-1
  • 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 biograph mct system running vg40a software may experience intermittent problems with ct or petct scans aborting during an examination. the problem is the result of an error in the software that is used to control the motion of the patient handling system during an examination. when the problem occurs, the patient handling system stops moving which then results in an abort of the current ct or petct scan.
  • Action
    Siemens is providing a software update to correct the problem.

Device

Biograph mCT Systems with VG40 Software (Diagnostic imaging system)
  • Model / Serial
    Biograph mCT Systems with VG40 Software (Diagnostic imaging system)ARTG Number: 144218
  • Manufacturer
    Siemens Ltd

Manufacturer

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