BEUDAMED
    FDA Enforcement Class II Terminated

    Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.

    Recall: Z-2621-2017 · Reported June 28, 2017

    Enforcement

    Recall Number
    Z-2621-2017
    Event ID
    77458
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Omega Medical Imaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 28, 2017
    Initiation Date
    March 23, 2017
    Classification Date
    June 22, 2017
    Termination Date
    December 11, 2019
    Address
    675 Hickman Cir, Sanford, FL, 32771-6931, United States

    Description

    Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.

    Reason

    Elevating Monitor Suspension column dropping and will not rise back up.

    Code Info

    SKF Telescopic Pillar P/N ending in -003

    Distribution

    Worldwide Distribution -US Distribution to states of: IN, OH, PA, and MT; and country of: Pakistan.

    Quantity

    6 units