Recall of ACUSON X700 Ultrasound System with software versions 1.0.00, 1.0.01, 1.0.02, 1.1.00 or 1.1.02

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
  • Event ID
  • Event Risk Class
    Class II
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    When foursight 4d ultrasound imaging, 3-scape real-time 3d imaging, or anatomical m-mode are used during an obstetric or gynecology studies, the following data from the previous patient could replace the current patient's data in the report:- clinical lmp (last menstrual period)- clinical edc (estimated date of confinement)- clinical ma (menstrual age)- indicationif the replaced data is not noticed, there is a potential risk of performing additional diagnostic or non-indicated therapeutic procedures.
  • Action
    To avoid this scenario, the following steps are recommended by Siemens: - Always review the patient report at the end of each study and confirm the report contains only measurements and patient data relevant to the exam just performed. - Before exiting fourSight 4D ultrasound imaging or 3-Scape (3D) imaging access and review the patient report. This step refreshes the data in the report. A new version of software resolving the error will be implemented in the affected units.


  • Model / Serial
    ACUSON X700 Ultrasound System with software versions 1.0.00, 1.0.01, 1.0.02, 1.1.00 or 1.1.02Catalogue/Lot number – 1065844 ARTG number: 137563
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source