BEUDAMED
    FDA Enforcement Class II Terminated

    Drop Arm Versamode"

    Recall: Z-1353-2021 · Reported April 14, 2021

    Enforcement

    Recall Number
    Z-1353-2021
    Event ID
    87606
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gf Health Products
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 14, 2021
    Initiation Date
    March 24, 2021
    Classification Date
    April 5, 2021
    Termination Date
    May 1, 2023
    Address
    1 Graham Field Way, N/A, Atlanta, GA, 30360-2808, United States

    Description

    Drop Arm Versamode"

    Reason

    The front casters on the 6810A Lumex Drop Arm Versamode are incorrect.

    Code Info

    Model: 6810A; Device Identifier: M36868101; and Lot number: BMW316BS

    Distribution

    Distributed nationwide to CA, WI, PA, IL, and TX. Distributed internationally to Mexico and Canada.

    Quantity

    66 units