Z-0086-2009

Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions Sonovista X300 software...

Name: Z-0086-2009 Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions Sonovista X300 software...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2008-08-19
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-08-19 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions Sonovista X300 software revision 1.0.06 and 1.0.07, Acuson X300 sofware... on 2008-08-19. The reason FDA records is "Incorrect value calculations by the device may result in inaccurate aortic stenosis estimates". 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-0086-2009
Status: Terminated
Initiated: 2008-08-19
Posted: 2008-10-08
Terminated: 2011-04-21
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions Sonovista X300 software revision 1.0.06 and 1.0.07, Acuson X300 sofware revision 1.0.08 ultrasound system with onscreen display.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Incorrect value calculations by the device may result in inaccurate aortic stenosis estimates.
Root cause tag: software
FDA root cause: Software design
Action: Siemens initiated a Field Correction 08/19/2008. Service personnel will conduct a site visit and distribute a Customer Safety Advisory Notice, correct the problem and install a revised software version.
Quantity in commerce: 169 units total
Distribution: Worldwide Distribution: USA, Singapore, Germany, Denmark, Romania, Sweden, Poland, Portugal, Australia, Chile, India, Spain, Thailand, Malaysia, South Africa, Hungary, Saudi Arabia, Qatar, Peru, Italy, Azerbaijan, Greenland, Austria, Venezuela, Puerto Rico, Brazil and Japan.
Product codes and lots: Sonovista: 10133170 (Japan only) Acuson: 10037409 (potentially affected but no volume: 10132987, 10038837). Software revisions 1.0.06 and 1.0.07 for Sonovista X300 and 1.0.08 for Acuson X300

Product code IYN

K061946Class IIAcuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. / cleared 2006-07-21

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)