Events

Recall of SOMATOM Definition AS, Definition Edge and Definition Flash CT scanners with coupled contrast agent injectors in software version VA48A-SP2 (diagnostic 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-00950-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00950-1
  • 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 have identified that when using the affected devices with software version va48a-sp2, problems can occur with the contrast agent injectors, regardless of the brand of injector involved. due to an internal communication error between the firmware and the software of the components involved, the planned ct scan is properly executed, however the injector is not started. this affects only the automatic mode, which is also called the "coupled mode", i.E. does not concern the manual control of the injector. as a result of this error, the contrast agent is not injected and the desired examination result is not achieved.
  • Action
    Siemens is advising users to stop using the automatic "coupled mode", and to only use control manually. Siemens will be implementing a firmware correction as a permanent fix. This action has been closed-out on 22/02/2017.

Device

SOMATOM Definition AS, Definition Edge and Definition Flash CT scanners with coupled contrast age...
  • Model / Serial
    SOMATOM Definition AS, Definition Edge and Definition Flash CT scanners with coupled contrast agent injectors in software version VA48A-SP2 (diagnostic 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