BEUDAMED
    FDA Enforcement Class II Ongoing

    WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI

    Recall: Z-1162-2021 · Reported March 10, 2021

    Enforcement

    Recall Number
    Z-1162-2021
    Event ID
    87264
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Nihon Kohden America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 10, 2021
    Initiation Date
    January 8, 2021
    Classification Date
    March 2, 2021
    Address
    90 Icon, Foothill Ranch, CA, 92610-3000, United States

    Description

    WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI

    Reason

    Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.

    Code Info

    ORG 9100A serial numbers: 00001 to 01413 ORG 9110A serial numbers: 00001 to 02706 ORG 9700A serial numbers: 00001 to 00894

    Distribution

    US - AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, ME, MA, MD, MI, MS, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA WI, WV and WY.

    Quantity

    4,436