Z-2065-2011

Acuson X300 systems at software versions 1.00.00 to 1.0.10 and 2.0.00 to 2.0.02, model numbers 10037409...

Name: Z-2065-2011 Acuson X300 systems at software versions 1.00.00 to 1.0.10 and 2.0.00 to 2.0.02, model numbers 10037409...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2009-07-30
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-07-30 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Acuson X300 systems at software versions 1.00.00 to 1.0.10 and 2.0.00 to 2.0.02, model numbers 10037409, 10132987, and 10038837, manufactured by Siemens... on 2009-07-30. The reason FDA records is "Software Error with potential for misinterpretation of data-- The previous patient's last capture clip image can appear in the next patient's study". 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-2065-2011
Status: Terminated
Initiated: 2009-07-30
Posted: 2011-04-25
Terminated: 2011-04-25
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Acuson X300 systems at software versions 1.00.00 to 1.0.10 and 2.0.00 to 2.0.02, model numbers 10037409, 10132987, and 10038837, manufactured by Siemens Medical Solutions ultrasound business unit, Mountain View, CA Medical device is an ultrasound imaging system 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. The system also provides for measurements of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Software Error with potential for misinterpretation of data-- The previous patient's last capture clip image can appear in the next patient's study.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Siemens, sent a "CUSTOMER SAFETY ADVISORY NOTIFICATION" letter to its customers on July 30, 2009. The letter described the product, problem and actions to be taken. The customers were instructed they need to update any of the patient registration settings to reset the cine buffer so that no data is transferred between studies, if the system software is not being updated. Siemens informed the customers that a mandatory update software is being installed on their system free of charge. If you have any questions, contact (650) 969-9112.
Quantity in commerce: 2312 units
Distribution: Worldwide distribution: USA (nationwide) and countries including: Albania, algeria, Argentina, Australia, Austria, Azerbaijan, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile,China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Kazakhstan, Kenya, Kosovo, Lativia, Lithuania, Luxembourg, New, Zealand, Nicaragua, Norway, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.
Product codes and lots: Serial numbers

Product code IYN

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)