Z-1853-2011

Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0

Name: Z-1853-2011 Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0
Creator: Siemens Medical Solutions USA, Inc.
Published: 2010-03-01
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2010-03-01 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0 on 2010-03-01. The reason FDA records is "Image captured from the device may be erroneous". 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-1853-2011
Status: Terminated
Initiated: 2010-03-01
Posted: 2011-03-30
Terminated: 2012-06-18
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Image captured from the device may be erroneous.
Root cause tag: software
FDA root cause: Software design
Action: Acuson Customer Safety Advisory notification letters were sent March 1, 2010 by certified mail.
Quantity in commerce: 3539
Distribution: Worldwide distribution to USA, Andorra, United Arab Emirates, Netherlands Antilles, Angola, Austria, Australia, Azerbaijan, Bosnia, Bangladesh, Belgium, Bahrain, Brunei Darussalam, Brazil, Belarus, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, Faroe Islands, France, Great Britain, Georgia, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iran, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Sri Lanka, Lithuania, Latvia, Morocco, Moldova, Mexico, Nicaragua, Netherlands, Norway, New Zealand, Oman, Peru, Philippines, Pakistan, Poland, Portugal, Qatar, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovak Republic, Suriname, Thailand, Turkey, Trinidad and Tobago, Taiwan, Ukraine, UA, Uruguay, Venezuela, Vietnam, Yemen, and South Africa.
Product codes and lots: ACUSON Antares: Model numbers: 10032747, 10037592, 10040728; SONOLINE Antares: Model numbers: 5936518, 08653771, 10037593; ACUSON Antares PE: Model Numbers: 10032746, 10037591, 10038202, 10040729. Serial Nos. beginning with 10 or 11 with software versions 4.0 and 5.0.

Product code IYN

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)