Class 2 Device Recall Acuson Antares Utrasound imaging device

• Date Initiated by Firm: March 01, 2010
• Date Posted: March 30, 2011
• Recall Status: Terminated on June 18, 2012
• Recall Number: Z-1853-2011
• Recall Event ID: 54844
• 510(K)Number: K023720 K033196 K050034 K063803
• Product Classification: Utrasound imaging device - Product Code IYN
• Product: Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc.; 1230 Shorebird Way; P.O. Box 7393; Mountain View CA 94043
• For Additional Information Contact: Kristen Dorrough; 650-694-5993
• Manufacturer Reason for Recall: Image captured from the device may be erroneous.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYN; 510(K)s with Product Code = IYN