Events

Recall of ACUSON S Family Ultrasound Systems with software versions VC25D, VC30A, VC30B

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-00657-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-06-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00657-1
  • 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
    A potential measurement error may occur in all exams (except cardiac) when using the auto-stats tool or the velocity tool during live imaging and when adjusting one of the following parameters with the auto-stats tool enabled:- changing the transmit frequency of the active transducer using the pw multihz control. - adjusting the position of the spectral baseline using the baseline control.- adjusting the pulsed repetition frequency (prf) using the scale control. during system freeze, the measured results indicate the scale values prior to adjustment of any of the above parameters. as a result, the measurements and/or calculations will be incorrect. to date, no patient injury has been reported as a result of this issue.
  • Action
    Siemens is advising operators that the issue can be avoided by not using the Auto-Stats tool and to only use the Velocity tool on frozen images. A Siemens service engineer will be in contact to update to software to correct the issue. Users are advised that a look back at previously reported results should be considered at the discretion of the clinician. Thia action has been closed-out on 28/01/2016.

Device

ACUSON S Family Ultrasound Systems with software versions VC25D, VC30A, VC30B
  • Model / Serial
    ACUSON S Family Ultrasound Systems with software versions VC25D, VC30A, VC30BARTG Number: 137563
  • Product Classification
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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