BEUDAMED
    FDA Enforcement Class II Terminated

    PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered

    Recall: Z-0013-2018 · Reported October 18, 2017

    Enforcement

    Recall Number
    Z-0013-2018
    Event ID
    78096
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Handicare Usa Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 18, 2017
    Initiation Date
    September 8, 2017
    Classification Date
    October 6, 2017
    Termination Date
    December 17, 2018
    Address
    10888 Metro Ct, Maryland Heights, MO, 63043-2413, United States

    Description

    PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered

    Reason

    During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap for lifts manufactured between April 25, 2017 and June 12, 2017 may wear prematurely at max load (625 lbs). We have identified the root cause as a supplied component that was not to specification. If the strap wears during use there is a potential risk for the person being supported by the lift to drop.

    Code Info

    A6M0001526, A6M0001527, A6M0001528, A6M0001529, A6M0001530, A6M0001485, A6M0001486, A6M0001498

    Distribution

    Us and Canada

    Quantity

    8 units