Events

Recall of SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic 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-01422-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01422-1
  • 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 become aware that in rare cases the small light marker window used for the positioning laser and integrated in the front cover of the ct could loosen and potentially fall/drop out. this could lead to a risk of electrical shock or physical harm to fingers if a person touched the rotating or electrical parts of the gantry when reaching through the window opening.
  • Action
    Siemens is developing a solution for the problem and this will be implemented as a permanent correction. In the interim, users should maintain awareness until a solution is implemented. They should not use the CT system in case a light marker window is missing or loose and is advised to inform the Siemens Service immediately.

Device

SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic system)
  • Model / Serial
    SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic system)SOMATOM Definition AS (manufactured from May 2008 - Dec 2013) Catalogue Number: 8098027SOMATOM Definition Flash (manufactured from Sept 2009 - Jul 2012)Catalogue Number: 10430603ARTG Number: 274034
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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