BEUDAMED
    FDA Recall Open, Classified

    Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements Model: CNS-350

    Recall: Z-1338-2023 · Initiated February 20, 2023

    Recall

    Recall Number
    Z-1338-2023
    Event Number
    91782
    Firm
    Moberg Research, Inc.
    FEI Number
    3007880955
    Product Code
    OMA
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 20, 2023
    Posted
    April 4, 2023
    Address
    224 S Maple Way, Ambler, PA, 19002-5528

    Description

    Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements Model: CNS-350

    Reason

    Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC

    Action

    Natus issued Letters Urgent Medical Device Recall Letter Component Neuromonitoring System (Moberg CNS Monitor Model CNS-350) via first class beginning Feb 20, 2023. Letter states reason for recall, health risk and action to take: Ensure that the CNS is either shut down or plugged into a power outlet. Perform the next step while using proper personal protective equipment (PPE), including gloves. On the top of the CNS-350 device, open each of the three (3) battery ports and remove any backup battery. 2) Inspect the battery and the battery port for any white, brown, or green/blue buildup, or for any corrosion of the metal contact locations. a. Dispose of the battery at your local electronic e-waste facility. Note: The CNS-350 device may continue to be used (while plugged into a power outlet) with the backup battery removed. b. If battery leakage or corrosion is suspected, cease use of the CNS-350 device. New replacement battery will be shipped to you. The Moberg Technical Service department will be in contact with you in relation to the provision of the replacement product. For new battery replacement, installation instructions will be provided with the battery.

    Distribution

    Worldwide distribution - US Nationwide and the countries of France, Germany, Italy, Sweden.

    Quantity

    89 units