BEUDAMED
    FDA Recall Terminated

    Cathcor/LX/Desktop, System, X-Ray, Angiographic

    Recall: Z-1032-03 · Initiated November 27, 2002

    Recall

    Recall Number
    Z-1032-03
    Event Number
    26574
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 27, 2002
    Posted
    July 19, 2003
    Terminated
    October 3, 2006
    Address
    51 Valley Stream Parkway, Malvern, PA, 19355

    Description

    Cathcor/LX/Desktop, System, X-Ray, Angiographic

    Reason

    Incorrect CTR values are found when used with ODBC interface, and may result in misdiagnosis.

    Action

    A Customer Safety Advisory Letter was sent via registered mail on 10/30/2002.

    Distribution

    5 Hospitals/Clinics in the US.

    Quantity

    9