BEUDAMED
    FDA Recall Terminated

    MR Systems

    Recall: Z-1087-03 · Initiated February 28, 2003

    Recall

    Recall Number
    Z-1087-03
    Event Number
    26218
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 28, 2003
    Posted
    August 7, 2003
    Terminated
    December 23, 2004
    Address
    51 Valley Stream Parkway, Malvern, PA, 19355

    Description

    MR Systems

    Reason

    software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.

    Action

    The recalling firm issued three separate customer advisory letters dated 2/28/03, 03/01/03, and 4/14/03 to their customers explaining the problem and the preventive measure to avoid loss of information.

    Distribution

    The product was shipped to distributors, medical facilities and Siemens training facilities nationwide.

    Quantity

    1374 units