BEUDAMED
    FDA Enforcement Class II Ongoing

    Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 LokomatPro L6.2 110V FD PE; 30684 LokomatPro L6.2 110V FD Kombi; 32001 LokomatPro L6.2 110V FD AD Product Usage: The intended use of the Lokomat is to support treadmill training to treat patients with walking disabilities caused by neurological, muscular or bone-related disorders. isokinetic testing and evaluation system

    Recall: Z-2418-2020 · Reported July 1, 2020

    Enforcement

    Recall Number
    Z-2418-2020
    Event ID
    85857
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hocoma AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 1, 2020
    Initiation Date
    June 8, 2020
    Classification Date
    June 23, 2020
    Address
    Industriestrasse 4, N/A, Volketswil, N/A, N/A, Switzerland

    Description

    Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 LokomatPro L6.2 110V FD PE; 30684 LokomatPro L6.2 110V FD Kombi; 32001 LokomatPro L6.2 110V FD AD Product Usage: The intended use of the Lokomat is to support treadmill training to treat patients with walking disabilities caused by neurological, muscular or bone-related disorders. isokinetic testing and evaluation system

    Reason

    The motor controller may fail, which can potentially lead to an error in functionality of the Body Weights Support Rope, which means that the rope can go up or down in an uncontrolled way.

    Code Info

    All units

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, MN, MO, NE, NY, TX.

    Quantity

    494