BEUDAMED
    FDA Enforcement Class II Terminated

    Omega Incline Platform Lift

    Recall: Z-1880-2017 · Reported May 3, 2017

    Enforcement

    Recall Number
    Z-1880-2017
    Event ID
    77053
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Savaria Concord Lifts, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 3, 2017
    Initiation Date
    April 12, 2017
    Classification Date
    April 26, 2017
    Termination Date
    October 16, 2017
    Address
    2 Walker Dr, N/A, Brampton, N/A, N/A, Canada

    Description

    Omega Incline Platform Lift

    Reason

    Savaria Concord Lifts Inc has decided to initiate this recall of its Omega Incline Platform Lift because bolts can come loose causing the carriage to separate from the trolley and the unit to fail

    Code Info

    s/n or lot number - Job Number 630046 through 630119

    Distribution

    Worldwide Distribution - US Distribution and to North America.

    Quantity

    74