BEUDAMED
    FDA Recall Terminated

    Acuson S2000 Ultrasound System with software and imaging. The Acuson S2000 ultrasound imaging systems are intended for these applications: fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications. Also for anatomical structures and calculation packages that provide information that provide information to the clinician...for clinical diagnosis purposes.

    Recall: Z-1832-2011 · Initiated March 1, 2010

    Recall

    Recall Number
    Z-1832-2011
    Event Number
    54842
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 1, 2010
    Posted
    March 28, 2011
    Terminated
    June 18, 2012
    Address
    1230 Shorebird Way P.O. Box 7393, Mountain View, CA, 94043

    Description

    Acuson S2000 Ultrasound System with software and imaging. The Acuson S2000 ultrasound imaging systems are intended for these applications: fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications. Also for anatomical structures and calculation packages that provide information that provide information to the clinician...for clinical diagnosis purposes.

    Reason

    "Any 2D measurement performed in Exam Review or offline, on a zoomed Retrospective clip capture may be erroneous. This applies to 2D, 2D/PW, 2D/CW and 2D/M-mode."

    Action

    Siemens Medical Solutions USA, Inc. sent a Consumer Safety Advisory Notification letter on February 16, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the Customer Safety Notice to all those within their organization who need to be aware of the issue until the corrective action was completed. For questions regarding this recall call 650-694-5580.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Australia, Belgium, Bolivia, Brazil, Bahamas, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Ecuador, Eguypt, Spain, Finald, France, Great Britian, Germany, Hong Kong, Croatia, Indonesia, Ireland, Israel, India, Ireland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Lithuania, Mexico, Malaysia, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Slovenia, Slovak Republic, Thailand, Turkmenistan, Tunisia, Turkey, Taiwan, Ukraine, Venezeula, Yemen, and South Africa..

    Quantity

    1903