BEUDAMED
    FDA Enforcement Class II Terminated

    Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.

    Recall: Z-1523-2022 · Reported August 24, 2022

    Enforcement

    Recall Number
    Z-1523-2022
    Event ID
    90620
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Myolyn Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 24, 2022
    Initiation Date
    July 19, 2022
    Classification Date
    August 16, 2022
    Termination Date
    September 23, 2024
    Address
    6931 Nw 22nd St Ste A, Gainesville, FL, 32653-1231, United States

    Description

    Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.

    Reason

    Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.

    Code Info

    Serial numbers 000800 thru 000819, 000821 thru 000822, 000824 thru 000827, 000829 thru 000831, 000835, 000836, 000840 thru 000842, 000850 thru 000852, and 000857 thru 000859; UDI 000861553000417

    Distribution

    Distribution was made to AZ, CA, CT, FL, GA, ID, IL, KY, MA, MI, MN, MO, MN, NC, NJ, NM, NY, OH, OR, TX, UT, VA, WA, and WI. There was no foreign/military/government distribution.

    Quantity

    45 devices