BEUDAMED
    FDA Enforcement Class II Ongoing

    Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

    Recall: Z-0160-2024 · Reported November 1, 2023

    Enforcement

    Recall Number
    Z-0160-2024
    Event ID
    93123
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Omega Medical Imaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 1, 2023
    Initiation Date
    September 8, 2023
    Classification Date
    October 24, 2023
    Address
    3400 Saint Johns Pkwy Ste 1020, N/A, Sanford, FL, 32771-6769, United States

    Description

    Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

    Reason

    An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became detached at the point shown and was restrained by the installed safety cable.

    Code Info

    all units manufactured between 10-22-2012 and 07-09-2019

    Distribution

    Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma

    Quantity

    31 units