Events

Recall of SOMATOM CTs: Definition Flash, Definition Edge, Definition AS and Definition (full body CT diagnostic x-ray systems) equipped with software syngo CT2010A, CT2010B, CT2011A and CT2012B

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-2012-RN-01298-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-01-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01298-1
  • 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
    There is a sporadic malfunction concerning 3d reconstructions during activated "preview image" functionality. the problem may occur during the process of 3d recon job planning and editing within the "examination" card while the "preview image" functionality is activated; when switching then to another recon job the system might sporadically hang up.
  • Action
    The customer letter identifies the software workarounds to mitigate the problems temporarily. Siemens will schedule software upgrades shortly for mitigating the problems permanently.

Device

SOMATOM CTs: Definition Flash, Definition Edge, Definition AS and Definition (full body CT diagno...
  • Model / Serial
    SOMATOM CTs: Definition Flash, Definition Edge, Definition AS and Definition (full body CT diagnostic x-ray systems) equipped with software syngo CT2010A, CT2010B, CT2011A and CT2012BARTG Number: 164065
  • Manufacturer
    Siemens Ltd

Manufacturer

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