Z-1767-2008

Sonoline Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following...

Name: Z-1767-2008 Sonoline Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2008-03-21
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-03-21 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of 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... on 2008-03-21. The reason FDA records is "Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis". 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-1767-2008
Status: Terminated
Initiated: 2008-03-21
Posted: 2008-09-02
Terminated: 2009-09-30
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
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.
Root cause tag: software
FDA 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 in commerce: 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
Product codes and lots: 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

Product code IYO

K063803Class IIAcuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI / cleared 2007-01-05

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)