Z-2051-2011

ACUSON S2000 ultrasound system Manufactured by Siemens Medical Solutions USA, Inc. Business Unit Ultrasound...

Name: Z-2051-2011 ACUSON S2000 ultrasound system Manufactured by Siemens Medical Solutions USA, Inc. Business Unit Ultrasound...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2011-03-15
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-03-15 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of ACUSON S2000 ultrasound system Manufactured by Siemens Medical Solutions USA, Inc. Business Unit Ultrasound, 1230 Shorebird Way Intended for the following... on 2011-03-15. The reason FDA records is "The Firm discovered a software error on the Accuson S2000 ultrasound systems affecting the measurement results in the patient report". 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-2051-2011
Status: Terminated
Initiated: 2011-03-15
Posted: 2011-04-22
Terminated: 2012-06-18
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ACUSON S2000 ultrasound system Manufactured by Siemens Medical Solutions USA, Inc. Business Unit Ultrasound, 1230 Shorebird Way Intended for the following applications: Fetal, abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal and Peripheral Vascular Applications.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: The Firm discovered a software error on the Accuson S2000 ultrasound systems affecting the measurement results in the patient report.
Root cause tag: software
FDA root cause: Software design
Action: Siemens issued a Customer Safety Advisory Notification letter to all customers on March 15, 2011, regarding a software error on the ACUSON S2000 ultrasound systems affected measurement . They are in the process of releasing a software update that will correct this issue. Siemens recommends reviewing the patient report at the end of each study to confirm that the report contains only measurements relevant to the exam just performed. No patient injury has been reported. Further questions regarding this recall please call (650) 694-5398.
Quantity in commerce: 1533 units
Distribution: Worldwide Distribution including USA, states of AZ, VA, CA, NE, IL, MN, TN, FL, NM, and DC
Product codes and lots: Model Number 10041461-ACUSON S2000. Serial numbers to follow

Product code IYN

K082142Class IIAcuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI / cleared 2008-11-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)