BEUDAMED
    FDA Recall Terminated

    ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system. Siemens Medical Solutions USA, Inc., Mountain View, CA

    Recall: Z-0661-2008 · Initiated September 25, 2007

    Recall

    Recall Number
    Z-0661-2008
    Event Number
    45410
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 25, 2007
    Posted
    April 24, 2008
    Terminated
    December 20, 2010
    Address
    1230 Shorebire Way P.O. Box 7393, Mountain View, CA, 94043

    Description

    ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system. Siemens Medical Solutions USA, Inc., Mountain View, CA

    Reason

    Measurement Error affecting all Sequoia systems using the PAL video standard configuration and have a perspective PC installed: 1) The Sequoia" system is operating at a software revision below 8.0. 2) The Sequoia" system is configured to PAL video mode (normal for systems running at 240V 50 Hz.). 3) While using any of the Perspective" advanced display options listed above, an image or clip is t

    Action

    Consignees were notified via a Urgent Medical Device Notification letter/customer letter sent out on 9/25/2007 under Siemens update program US013/07/S. The Siemens Service organization coordinates the implementation of the field correction with the distributors for all countries. Consignees who do not respond to the recall communication will be visit ed and/or telephoned for follow up.

    Distribution

    Worldwide Distribution including the countries of: Australia, Austria, Belgium, Brazil, Brunei, China, Denmark, Finland, France, Germany, Great Britain (UK), Greece, Hungary, India, Iran, Ireland, Italy, Latvia, Netherlands, New Zealand, Romania, Russian Federation, Singapore, Spain, Switzerland, Thailand. U.S customers were not affected.

    Quantity

    280