BEUDAMED
    FDA Recall Terminated

    Magnetom Sonata MRI System, Model 7388148

    Recall: Z-1400-04 · Initiated July 28, 2004

    Recall

    Recall Number
    Z-1400-04
    Event Number
    29831
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 28, 2004
    Posted
    August 24, 2004
    Terminated
    January 25, 2005
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    Magnetom Sonata MRI System, Model 7388148

    Reason

    An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows

    Action

    The recalling firm issued a Customer Safety Advisory letter via certified mail to their customers per Update Instructions MR028/04/S. The letter informs customers of the potential issue and provides instructions to avoid its occurence.

    Distribution

    The products were shipped to 39 medical facilities in CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, MA, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, and VA.

    Quantity

    2 units