Events

Recall of ACUSON SC2000 Ultrasound Systems with Software Version 3.5 (VA35)

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-2014-RN-00539-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00539-1
  • 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
    The following issues may occur with cardiovascular studies after upgrading from software version 2.0 or 3.0 to software version 3.5 and restoring user-defined presets. this applies to all transducers except the 9l4 and 6c1 hd transducers:- the system may incorrectly display the colour flow data in the wrong position. the potential risk to the patient is misdiagnosis based on erroneous color flow data.The following issue may occur with software version 3.5:- when you adjust the doppler frequency, the system does not restart the pulsed wave doppler or continuous wave doppler waveform. however, the system displays previous doppler data using the new doppler scale which may result in inaccurate measurement values. the potential risk to the patient is misdiagnosis based on the same doppler profile providing two different velocity measurement values.
  • Action
    Siemens is advising their customers to use factory default presets with software version 3.5 instead of user defined presets restored from software version 2.0 or 3.0. After adjusting the Doppler frequency, freeze and un-freeze the system to refresh the display of the Doppler spectrum resulting in the correct measurements. Siemens will be replacing the software of all affected devices. Thia action has been closed-out on 28/01/2016

Device

ACUSON SC2000 Ultrasound Systems with Software Version 3.5 (VA35)
  • Model / Serial
    ACUSON SC2000 Ultrasound Systems with Software Version 3.5 (VA35)Catalogue Number: 10433816ARTG Number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

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