Events

Recall of ACUSON S1000, ACUSON S2000, or ACUSON S3000 Ultrasound Systems with software version VC30A, VC30B, VC30C, or VC31A

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-00599-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00599-1
  • 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 recently discovered a potential miscalculation when using the doppler manual trace measurement tool in a full screen display format. the manual trace tool may incorrectly calculate the time average velocity (tav) and subsequently incorrectly calculate the pulsatility index (pi). the potential risk is a misdiagnosis however, the probability is low.
  • Action
    This issue will be resolved in a future software release. In the interim to avoid this issue, users are advised not to perform measurements utilising the manual Doppler trace tool in a full screen display format. This action has been closed-out on 15/02/2017.

Device

ACUSON S1000, ACUSON S2000, or ACUSON S3000 Ultrasound Systems with software version VC30A, VC30B...
  • Model / Serial
    ACUSON S1000, ACUSON S2000, or ACUSON S3000 Ultrasound Systems with software version VC30A, VC30B, VC30C, or VC31AARTG Number: 137563
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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