BEUDAMED
    FDA Enforcement Class II Terminated

    2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.

    Recall: Z-2734-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2734-2016
    Event ID
    74886
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Omega Medical Imaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 14, 2016
    Initiation Date
    June 21, 2016
    Classification Date
    September 3, 2016
    Termination Date
    October 4, 2019
    Address
    675 Hickman Cir, Sanford, FL, 32771-6931, United States

    Description

    2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.

    Reason

    Elevating Monitor Suspension separated from the lifting column bracket

    Code Info

    Model: Elevating Monitor Suuspension P/Ns: 1000-0085, 1000-0095 and (1000-0129 one unit produced does not use bracket 1040-0071 or 1040-0031).

    Distribution

    CO, MN, GA, NC, IN, OH, KY, IL, NY, AL, MO, LA, PA, and SD Denmark

    Quantity

    26 units