BEUDAMED
    FDA Enforcement Class II Terminated

    A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical.

    Recall: Z-1405-2017 · Reported March 15, 2017

    Enforcement

    Recall Number
    Z-1405-2017
    Event ID
    76351
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ErgoSafe Products, LLC (DBA) Prism Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2017
    Initiation Date
    January 30, 2017
    Classification Date
    March 3, 2017
    Termination Date
    December 4, 2017
    Address
    10888 Metro Ct, N/A, Maryland Heights, MO, 63043-2413, United States

    Description

    A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical.

    Reason

    During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely.

    Code Info

    A6MC000110 A6M0001010 A6M0001011 A6M0001012 A6M0001013 A6M0001014 A6M0001015 A6M0001016 A6M0001017 A6M0001018 A6M0001019 A6M0001020 A6M0001021 A6M0001025 A6M0001026 A6M0001029 A6M0001022 A6M0001023 A6M0001024 A6M0001027 A6M0001028

    Distribution

    Product was distributed to MT and NV; one VA consignee.

    Quantity

    21