BEUDAMED
    FDA Enforcement Class II Terminated

    SonarMed AirWave Monitor, Model Number M0001

    Recall: Z-2450-2019 · Reported September 11, 2019

    Enforcement

    Recall Number
    Z-2450-2019
    Event ID
    82987
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SonarMed Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2019
    Initiation Date
    April 17, 2017
    Classification Date
    September 4, 2019
    Termination Date
    July 16, 2020
    Address
    12220 N Meridian St Ste 150, N/A, Carmel, IN, 46032-6972, United States

    Description

    SonarMed AirWave Monitor, Model Number M0001

    Reason

    Potential for the presence of two error codes which would make the monitor inoperable.

    Code Info

    UDI Numbers: (01)00851334007001(11)130426(21)339 (01)00851334007001(11)130502(21)342 (01)00851334007001(11)131105(21)365 (01)00851334007001(11)140522(21)369 (01)00851334007001(11)140522(21)373 (01)00851334007001(11)150609(21)379 (01)00851334007001(11)150609(21)381 (01)00851334007001(11)150609(21)382 (01)00851334007001(11)150630(21)383 (01)00851334007001(11)150630(21)385 (01)00851334007001(11)150630(21)386 (01)00851334007001(11)150630(21)388 (01)00851334007001(11)150630(21)389 (01)00851334007001(11)150630(21)390 (01)00851334007001(11)150701(21)391 (01)00851334007001(11)150701(21)393

    Distribution

    CA & TX

    Quantity

    16 units