BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1853-2011 · Initiated March 1, 2010

    Recall

    Recall Number
    Z-1853-2011
    Event Number
    54844
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 1, 2010
    Posted
    March 30, 2011
    Terminated
    June 18, 2012
    Address
    1230 Shorebird Way P.O. Box 7393, Mountain View, CA, 94043

    Description

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

    Reason

    Image captured from the device may be erroneous.

    Action

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

    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.

    Quantity

    3539