BEUDAMED
    FDA Enforcement Class II Terminated

    TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829

    Recall: Z-0037-2020 · Reported October 9, 2019

    Enforcement

    Recall Number
    Z-0037-2020
    Event ID
    83775
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Quality Electrodynamics LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2019
    Initiation Date
    August 20, 2019
    Classification Date
    October 3, 2019
    Termination Date
    May 26, 2020
    Address
    6655 Beta Dr Ste 100, N/A, Mayfield Village, OH, 44143-2380, United States

    Description

    TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829

    Reason

    Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.

    Code Info

    Serial # 1288 1466 2149 2570 2571 2573 2574 2575 2576 2577 2578 2579 2580 2581 2582 2583 2584 2585 ¿1029 1179 ¿1356

    Distribution

    Worldwide distribution - US in the states: NC OUS: Germany

    Quantity

    21 units