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-2015-RN-00035-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-01-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00035-1
  • 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
    An internal bolt intended to hold the control panel in a fixed position can fail. if this bolt fails, the operator cannot lock the control panel into position, and the steering and rotation of the console will also be affected. the up/down positioning is not affected. portable exams are not possible and bedside exams are more difficult without these positioning capabilities. there is potential risk for not controlling the system during transport or during a patient examination. potential harms include bruises, cuts, scrapes, or broken bones. to date no patient injury has been reported.
  • Action
    Affected customers will be contacted by Siemens to schedule the necessary repairs on site. This action has been closed-out on 03/08/2016.

Device

ACUSON SC2000 ultrasound systems
  • Model / Serial
    ACUSON SC2000 ultrasound systemsSystem material number 10433816 (specific serial number range with component material number 10852376 installed)ARTG number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

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