Events

Recall of ACUSON SC2000 ultrasound systems with software versions VA16A to VA30A and the Stress Echo Option

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-2015-RN-00720-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00720-1
  • 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
    When performing a 2d stress echo study, specific keystrokes may result in a potential loss of data, where some selected clips may not be saved as part of the study. the potential risk is that the stress echo study may need to be performed again.
  • Action
    Siemens is providing users with interim instructions to follow. A software update will be provided to affected users, which will resolve the issue. This action has been closed-out on 05/12/2016.

Device

ACUSON SC2000 ultrasound systems with software versions VA16A to VA30A and the Stress Echo Option
  • Model / Serial
    ACUSON SC2000 ultrasound systems with software versions VA16A to VA30A and the Stress Echo OptionCatalogue/Lot number – 10433816 (ACUSON SC2000) with software versions VA16A to VA30A and 10436375 (2D Stress Echo Licence)ARTG number: 139591
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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