FDA Medical Device Recalls (openFDA)
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 number
- Z-1767-2008
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- 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
- Status
- Terminated
- Initiated
- 2008-03-21
- Posted
- 2008-09-02
- Terminated
- 2009-09-30
- Reason
- Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 51 active units total
- Distribution
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K063803"]
- PMA numbers
- not on file
- Product code
- IYO
- Firm FEI
- 2936884
- Firm city
- Mountain View
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28