BEUDAMED
    FDA Enforcement Class II Terminated

    DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor 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-2441-2020 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2441-2020
    Event ID
    85685
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mediana Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 8, 2020
    Initiation Date
    May 15, 2020
    Classification Date
    June 26, 2020
    Termination Date
    September 16, 2022
    Address
    132 Donghwagongdan-Ro, Munmag-Eup, Wonju, N/A, N/A, Korea (the Republic of)

    Description

    DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor 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

    Failures were found in the temperature measurement function while in the predict mode.

    Code Info

    Serial Numbers: 456802000001~456802000180

    Distribution

    US Nationwide distribution.

    Quantity

    180 devices