BEUDAMED
    FDA Enforcement Class II Terminated

    TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician.

    Recall: Z-2314-2012 · Reported September 12, 2012

    Enforcement

    Recall Number
    Z-2314-2012
    Event ID
    62949
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Quality Electrodynamics LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    September 12, 2012
    Initiation Date
    July 27, 2012
    Classification Date
    September 6, 2012
    Termination Date
    February 19, 2013
    Address
    700 Beta Dr Ste 100, N/A, Mayfield Village, OH, 44143-2378, United States

    Description

    TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician.

    Reason

    On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because the coil identification code for the device was incorrect.

    Code Info

    QED part numbers: Q7000057/QED000057/QSV000057 Siemens part numbers: 10606829 / 10606614 Serial #s: 1002-1012, 1016-1020, and 1022.

    Distribution

    Worldwide distribution: USA (nationwide): Tennessee only and country of: Germany

    Quantity

    17 units