BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1943-2020 · Initiated June 15, 2016

    Recall

    Recall Number
    Z-1943-2020
    Event Number
    85362
    Firm
    Handicare AB Maskinvagen
    FEI Number
    3009481053
    Product Code
    FSA
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 15, 2016
    Address
    17 Lulea 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.

    Action

    The firm notified their consignees on 06/15/2016 by email. The notice explained the issue of wear in the joint of the lift arm due to abnormal use in heavy loads and/or many lifts. The consignee was directed to inspect the lifts in order to identify gaps and/or cracks and to report to the local Handicare sales representative and to Handicare. On April 4, 2019, the firm sent a reminder notice on 04/04/2019

    Distribution

    US and Mexico

    Quantity

    997 units