Z-1504-2014Class II

Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02...

Name: Z-1504-2014 Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2014-04-02
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-04-02 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system on 2014-04-02. FDA classified it as Class II and gives the reason as "When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the previous patient could replace the current patient's date in the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1504-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-02
Posted: 2014-04-24
Terminated: 2015-11-12
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the previous patient could replace the current patient's date in the report.
Root cause tag: software
FDA root cause: Software Design Change
Action: Siemens sent a Customer Safety Advisory Notification letter on April 2, 2014 to all affected customers via certified mail. The letter identified the affected product, problem and what actions to take until software is upgraded. For questions call 1-888-826-9702.
Quantity in commerce: 490
Distribution: Worldwide Distribution - US Nationwide and the countries of Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg., Brunei, Chile, Colombia, Croatia, Ecuador, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Libya, Liechtenstein, Malaysia, Mauritius, Montenegro, Namibia, Nepal, Nigeria, Norway, Palestinian Ter, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Saudi Arabia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey, Turkmenistan, U.A.E., United Kingdom.
Product codes and lots: Model numbers: 1065844 ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1504-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1504-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-24

Product code IYN

K123001Class IIAcuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. / cleared 2012-10-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)