BEUDAMED
    FDA Enforcement Class II Terminated

    AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.

    Recall: Z-2096-2021 · Reported July 28, 2021

    Enforcement

    Recall Number
    Z-2096-2021
    Event ID
    88166
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mediana Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 28, 2021
    Initiation Date
    May 17, 2021
    Classification Date
    July 19, 2021
    Termination Date
    November 4, 2022
    Address
    132 Donghwagongdan-Ro, Munmag-Eup, Wonju, N/A, N/A, Korea (the Republic of)

    Description

    AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.

    Reason

    In some cases the equipment fails to power up and/or key or button unresponsive or not working.

    Code Info

    Serial #(s) 460062000002 thru 460062000501 and 460062100033 thru 460062100150 UDI:(01)18800003460066

    Distribution

    US Distribution to: Wisconsin only

    Quantity

    618