BEUDAMED
    FDA Recall Terminated

    Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, Model Number: 8247887, Siemans, Mountain View, CA 94039

    Recall: Z-1107-2004 · Initiated September 18, 2007

    Recall

    Recall Number
    Z-1107-2004
    Event Number
    45411
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 18, 2007
    Posted
    February 15, 2008
    Terminated
    April 21, 2011
    Address
    1230 Shorebire Way P.O. Box 7393, Mountain View, CA, 94043

    Description

    Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, Model Number: 8247887, Siemans, Mountain View, CA 94039

    Reason

    Software error: Error affects all Aspen customer systems using the PAL video standard configuration and have a Perspective PC installed. This can lead to a measurement error under this specific condition: On secondary capture images/clips stored from within any Perspective advanced display option (specifically: 3D Surface Rendering, 3D MultiPlanar Reconstruction, Color Doppler 3D MultiPlanar Reco

    Action

    Siemens issued an Urgent Medical Device Notification to consignees 9/18/07, under Siemens update program US014/07/S. (Distribution on this product had ceased on 6/29/2005.) The firm has instructed the user to not take measurements or use measurements on these secondary captures under the conditions described in the notice, to place a copy of the instructions for use in the file, and to notify all users of the issue with the software. The Siemens Service organization has coordinated the implementation of the field correction with the distributors for all countries. Non-responding consignees will be visited or called by telephone for follow up.

    Distribution

    Worldwide Distribution --- including USA and countries of Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain (UK), Greece, Hong Kong, India, Italy, Jordan, Malaysia, Norway, Poland, Portugal, Romania, Russian Federation, Sweden, Switzerland, Thailand, and Turkey.

    Quantity

    280 units