—#73273

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.

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K061946
Affected lot / code info: 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

Why it was recalled

Incorrect value calculations by the device may result in inaccurate aortic stenosis estimates.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 1230 Shorebird Way P.O. Box 7393, Mountain View, California 94039-7393

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2008-08-19
Posted by FDA: 2008-10-08
Terminated: 2011-04-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73273. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.