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Terminated

Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0.

FDA Recall Z-1853-2011 · Posted 2011-03-30

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2010-03-01
Date Terminated2012-06-18
Product Quantity3539

Reason for Recall

Image captured from the device may be erroneous.

Firm Action

Acuson Customer Safety Advisory notification letters were sent March 1, 2010 by certified mail.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063803ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007-01-05K050034SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc. · 2005-01-13K033196SONOLINE ANTARES WITH CLARIFY VESiemens Medical Solutions USA, Inc. · 2003-10-16K023720SONOLINE ANTARES ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc. · 2002-11-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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