BEUDAMED
    FDA Enforcement Class II Ongoing

    EVA Floor Lifts, Model Numbers: 400, 450, 600

    Recall: Z-1943-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1943-2020
    Event ID
    85362
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Handicare AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 20, 2020
    Initiation Date
    June 15, 2016
    Classification Date
    May 8, 2020
    Address
    Maskinvagen 17, N/A, Lulea, N/A, N/A, Sweden

    Description

    EVA Floor Lifts, Model Numbers: 400, 450, 600

    Reason

    After feedback from customers and internal suspicion, Handicare has become aware that abnormal use of Eva-lifts could lead to a deterioation in the joint of the liftarm. This could lead to injury if the joint breaks. All lifts must therefore be checked and reported back to the manuafacturer.

    Code Info

    All affected models

    Distribution

    US and Mexico

    Quantity

    997 units