BEUDAMED
    FDA Enforcement Class II Terminated

    TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464

    Recall: Z-0033-2020 · Reported October 9, 2019

    Enforcement

    Recall Number
    Z-0033-2020
    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 CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464

    Reason

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

    Code Info

    Serial # 1308 1309 1310 1311 1313

    Distribution

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

    Quantity

    5 units