Events

Recall of SOMATOM Force with software version VA50_SP2 (Computed tomography x-ray system)

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-2016-RN-01461-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01461-1
  • 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
    Customers with software version va50_sp2 will be provided an update to software version va50_sp3. the installation of this update will address software bugs that were identified through field monitoring. some of the major bug fixes that will be addressed with this software are:1) correction to volumetric misrepresentations of high contrast objects when using admire.2) correction to highly sporadic scan aborts due to temporarily tube currents at 0ma.3) correction to missing microsoft hotfixes (ms16-001, ms15-135, ms15-088, ms15-048). 4) correction to highly sporadic image artefacts caused by error signals from high voltage chain at extremely high tube currents.5) correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed.6) correction to highly sporadic scan aborts due to temporarily high disk load of system disk.7) correction to highly sporadic image artefacts generated by scatter correction in case of tube arcing.
  • Action
    Customers are advised that the update will be remotely pushed to the system or Siemens will contact customers to arrange a date for the installation of the software update onsite.

Device

SOMATOM Force with software version VA50_SP2 (Computed tomography x-ray system)
  • Model / Serial
    SOMATOM Force with software version VA50_SP2 (Computed tomography x-ray system)ARTG Number : 274034
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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