—#69712

Product

Sonoline Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following options installed: 3-Scape Imaging, Factory, PN 05937011 or 3-Scape Imaging, Field Upgrade, PN 07472520. Material number 5936518, 8653771 or 10037593

FDA product code: IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K063803
Affected lot / code info: serial numbers 10163 10524 11148 11149 11150 110920 111158 111270 111287 111377 111389 111514 111558 111584 111712 111871 112317 112322 112388 112809 10188001 10437001 10566001 10604001 10669001 11008001 11047001 111552001 111692001 112081001 112081002 112087001 112089001 112117001 112178001 112182001 112306001 112360001 112384001 112554001 112597001 112697001 112704001 112743001 112744001 112776001 112859001 10722 111456 112288 112608

Why it was recalled

Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.

Root cause (FDA determination)

Software design

Action the firm took

The firm initiated a field correction on 03/21/2008. Site visits to correct the problem and install the revised software version 200.0.063A are planned for all consignees. No other notification was made. The firm can be contacted at 650-694-5993.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 1230 Shorebire Way P.O. Box 7393, Mountain View, California 94043

Distribution

Distribution pattern: Product was distributed worldwide to 539 consignees, in the USA to MD, SC, AZ, FL, IL, WI, NJ, NC, CA, OH, VA TX, PA MO, NH, IA, NE, MN, NY, GA, MI, WA, HI, MA, SC, WV, VA, ND, IN, WY, UT, MS, TN, PR, SD, KY, OK, OR, and worldwide to Sweden, Saudi Arabia, Austria, New Zealand, Italy, Switzerland, Mexico, Germany, Australia, Canada, Great Britain, France, China, South Korea, Singapore, Denmark, Brazil, Poland, Norway, Faroe Islands, South Africa, Russian Federation, Romania, Trinidad and Tobago, Greece, India, Spain, Thailand, Ukraine, Nicaragua, Japan, India, Czech Republic, Egypt, Taiwan, Turkey, Malaysia, Qatar, Bosnia an dHerzogovina, Vietnam, Brunei Darussalam, Italy, Kuwait, Turkey, Portugal

Timeline

Recall initiated: 2008-03-21
Posted by FDA: 2008-09-02
Terminated: 2009-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69712. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.