Z-1616-2012

ACUSON S1000 ultrasound systems running software version 1.0, Siemens Medical Solutions, USA, Inc. Mountain...

Name: Z-1616-2012 ACUSON S1000 ultrasound systems running software version 1.0, Siemens Medical Solutions, USA, Inc. Mountain...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2012-04-25
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-04-25 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of ACUSON S1000 ultrasound systems running software version 1.0, Siemens Medical Solutions, USA, Inc. Mountain View, CA. The product is indicated for use as an... on 2012-04-25. The reason FDA records is "When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale". 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-1616-2012
Status: Terminated
Initiated: 2012-04-25
Posted: 2012-05-16
Terminated: 2012-10-19
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ACUSON S1000 ultrasound systems running software version 1.0, Siemens Medical Solutions, USA, Inc. Mountain View, CA. The product is indicated for use as an ultrasound imaging system.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale.
Root cause tag: software
FDA root cause: Software design
Action: A field corrective action was initiated on 04/25/2012 under Siemens update program US019/12/S in which a "Customer Safety Advisory Notice" was sent to all customers notifying them of the problem and the recommended actions to avoid potential risk. A follow-up field corrective action will be initiated in which the affected software will be updated in the field.
Quantity in commerce: 45
Distribution: Worldwide Distribution -- USA, including the states of TX, NJ, GA and the countries of Germany, United Kingdom, Republic of Korea, Australia, Japan, Poland, Israel, Singapore, France and Saudi Arabia.
Product codes and lots: Serial numbers: 205730 205732 205523 205557 205721 205704 205747 205709 205685 205796 205751 205797 205771 205786 205795 205775 205785 205773 205783 205782 205791 205793 205789 205804 205873 205848 205821 205811 205840 205708 205909 206029 206072 205814 205977 205935 205971 206089 206120 205988 206112 206038 206087 205956 205937.

Product code IYN

K111674Class IIAcusonSiemens Medical Solutions USA, Inc. / cleared 2011-06-30

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)