Events

Recall of ACUSON SC2000 Ultrasound Systems

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-00076-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-01-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00076-1
  • 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 locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel. if the locking mechanism fails, there is the potential risk the user will be unable to steer or control the ultrasound system during transport.
  • Action
    Siemens is advising that if a user is unable to lock the rotation of the control panel or experiences rotation of the control panel or progressively greater left to right movement when the control panel lock is engaged, park the ultrasound system and contact Siemens. Siemens will be contacting all affected users to make the required repairs to the affected systems.

Device

ACUSON SC2000 Ultrasound Systems
  • Model / Serial
    ACUSON SC2000 Ultrasound SystemsSerial Numbers: 401100 to 401400ARTG Number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

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