BEUDAMED
    FDA Enforcement Class II Ongoing

    Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box

    Recall: Z-0267-2025 · Reported November 6, 2024

    Enforcement

    Recall Number
    Z-0267-2025
    Event ID
    95426
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Nihon Kohden America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2024
    Initiation Date
    September 18, 2024
    Classification Date
    October 30, 2024
    Address
    15353 Barranca Pkwy, N/A, Irvine, CA, 92618-2216, United States

    Description

    Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box

    Reason

    Due to oximeters not having FDA market approval or clearance to distribute in the U.S.

    Code Info

    Model num.: 809030006 UDI-DI: 06970758500173 All lot numbers

    Distribution

    U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, MA, MD, MI, MO, MT, NC, ND, NE, NH, OK, PA, SC, TX, VT, WA, and WI. O.U.S.: N/A

    Quantity

    67