BEUDAMED
    FDA Enforcement Class II Terminated

    TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828

    Recall: Z-0036-2020 · Reported October 9, 2019

    Enforcement

    Recall Number
    Z-0036-2020
    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: Q7000056 Siemens Model # 10606828

    Reason

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

    Code Info

    Serial # 1694 1841 1887 1933 1998 3195 3291 3292 3293 3294 3298 3299 3300 3301 3302 3303 3304 3305 3306 3307 3308 3309 3310 3311 3312 3313 3314 3315 3316 3317 3318 ¿1137 ¿1361 ¿1378 ¿1628 ¿2447

    Distribution

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

    Quantity

    36 units