Events

Recall of Acuson S2000 and Acuson S3000 Ultrasound Systems with the Virtual Touch IQ option

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-2015-RN-00595-1
  • Event Risk Class
    Class I
  • 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-00595-1
  • 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 healthcare received complaints that when repositioning the virtual touch iq region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data. the maximum error in position between the measurement tool and shear velocity data is 3.8 mm. the issue of concern is a potential underestimation of maximum shear wave velocity of a lesion. this underestimation may lead to a user deciding not to biopsy a cancerous lesion. the potential risk of misdiagnosis associated with this issue is low.
  • Action
    Siemens Healthcare is requesting the customers not reposition the Virtual Touch IQ region of interest from the original (default) location. Siemens is also requesting the customers to review previously performed studies to ensure the results are as expected. This issue will be resolved in a future software release. This action has been closed-out on 01/03/2018.

Device

Acuson S2000 and Acuson S3000 Ultrasound Systems with the Virtual Touch IQ option
  • Model / Serial
    Acuson S2000 and Acuson S3000 Ultrasound Systems with the Virtual Touch IQ optionARTG Number: 137563
  • Product Classification
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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