BEUDAMED
    FDA Recall Terminated

    SonarMed AirWave Monitor, Model Number M0001

    Recall: Z-2450-2019 · Initiated April 17, 2017

    Recall

    Recall Number
    Z-2450-2019
    Event Number
    82987
    Firm
    SonarMed Inc
    FEI Number
    3009923584
    Product Code
    OQU
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 17, 2017
    Terminated
    July 16, 2020
    Address
    12220 N Meridian St, Ste 150, Carmel, IN, 46032-6972

    Description

    SonarMed AirWave Monitor, Model Number M0001

    Reason

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

    Action

    April 2017, firm notifications were made in person at the time of the visit to upgrade the firmware. All monitors that had not been distributed were upgraded to the new firmware. All subsequent shipments will have the updated firmware.

    Distribution

    CA & TX

    Quantity

    16 units