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-00486-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00486-1
  • 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 when using the stress echo feature:- shorter-than-expected clips may occur when using systolic-only captures with heart rates at approximately 120bpm (beats per minute) and higher. this computational error may occur at any heart rate; but the system produces a smaller error for lower heart rates. the issue may also cause the system to change from systolic-only captures to full beat (r-r).- intermittently, some post-exercise clips may not be captured during continuous capture acquisition. - post-exercise clips marked for deletion (unselected clips) may be restored to the study after cycling power to the system. the potential risk to the patient may be a repeated stress echo study.
  • Action
    A software update will be provided to correct this problem. End users are advised to avoid the potential risks associated with this issue by: - Discontinue use of the stress echo feature with software version 3.5 - For studies acquired with the systolic only captures, review all patient studies on exams performed after the software revision 3.5 was installed.

Device

ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35)
  • Model / Serial
    ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35)ARTG Number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

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