Events

Recall of ACUSON SC2000 ultrasound systems with software versions VB10B and lower

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-00816-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00816-1
  • 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 acuson sc2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. the system recalls the case sensitivity even if the original study has been removed from the hard drive. if these differences are not corrected at the time of registration, the system does not capture images or clips.The potential risk is the study data, including measurements, may not be captured and the study will need to be re-performed.
  • Action
    Siemens is providing work around instructions to follow as an interim measure. A software upgrade will be provided as a permanent solution. This action has been closed-out on 18/04/2017.

Device

ACUSON SC2000 ultrasound systems with software versions VB10B and lower
  • Model / Serial
    ACUSON SC2000 ultrasound systems with software versions VB10B and lowerLot number: 10433816ARTG number: 139591
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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