Events

Recall of Biograph mCT systems running the VG40A or VG40B software(Digital 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-00623-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-06-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00623-1
  • 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
    This recall action is an update to rc-2013-rn-00357-1.Siemens has identified that biograph mct systems running software vg40a or vg40b can experience intermittent aborting of ct or pet/ct scans during an examination, in addition to intermittent ct planning and image reconstruction failures. these issue are due to software errors.
  • Action
    Siemens is advising end users on how a check can be performed during the planning of the CT acquisitions and reconstructions, within a PET/CT protocol that could indicate that a problem is likely to occur. The problems will be addressed in the upcoming VG40C software release which is planned to be released within the next 2 months.

Device

Biograph mCT systems running the VG40A or VG40B software(Digital Imaging System)
  • Model / Serial
    Biograph mCT systems running the VG40A or VG40B software(Digital Imaging System)
  • Manufacturer
    Siemens Ltd

Manufacturer

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