Z-2147-2011

Siemens ACUSON X300 Systems with software versions 3.0.00 and 3.0.02, model numbers 10348531, 10348532 and...

Name: Z-2147-2011 Siemens ACUSON X300 Systems with software versions 3.0.00 and 3.0.02, model numbers 10348531, 10348532 and...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2009-07-24
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-07-24 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Siemens ACUSON X300 Systems with software versions 3.0.00 and 3.0.02, model numbers 10348531, 10348532 and 10348533, manufactured by Siemens Medical Solutions... on 2009-07-24. The reason FDA records is "Mistreatment risk-- when a user defined formula is used to calculate a value in a vascular exam, data is switched laterally when it is internally transferred and displayed on the summary report within the system". 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-2147-2011
Status: Terminated
Initiated: 2009-07-24
Posted: 2011-05-06
Terminated: 2011-05-09
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens ACUSON X300 Systems with software versions 3.0.00 and 3.0.02, model numbers 10348531, 10348532 and 10348533, manufactured by Siemens Medical Solutions, Mountain View, CA. Intended for General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: Mistreatment risk-- when a user defined formula is used to calculate a value in a vascular exam, data is switched laterally when it is internally transferred and displayed on the summary report within the system.
Root cause tag: software
FDA root cause: Software design
Action: A field correction was initiated and a Customer Safety Advisory Notification was sent out on 7/29/09. The letter identified the affected product and stated that there was a potential for user defined calculations to be incorrect within the vascular package when using the listed software versions of the product. The letter also discussed the steps that customers could take to avoid the potential risk of the issue. A mandatory update software was developed and will be installed free of charge. Customers should have been contacted to schedule a time for the installation. Questions were to be directed to the local service support person.
Quantity in commerce: 154 units
Distribution: Worldwide Distribution -- Austria, Brazil, China, Columbia, Germany, Denmark, Egypt, Great Britain, Honduras, Ireland, India, Italy Japan, South Korea, Mexico, Malaysia, Peru, Poland, Portugal, Romania, Russia, Sweden, Singapore, Thailand, Turkey, Taiwan, United States, Uruguay, Venezuela, and South Africa.
Product codes and lots: Systems with software versions 3.0.00 and 3.0.02.

Product code IYO

K072676Class IIAcuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc. / cleared 2007-12-18

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)