Siemens Medical Solutions USA, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Siemens Medical Solutions USA, Inc. is recalling Sonoline Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the follo due to Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, GA, HI, IL, IN, IA, KY, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, PR
Page updated: Jan 10, 2026