BEUDAMED
    FDA Recall Open, Classified

    AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.

    Recall: Z-1535-2024 · Initiated March 25, 2024

    Recall

    Recall Number
    Z-1535-2024
    Event Number
    94302
    Firm
    SonarMed Inc
    FEI Number
    3009923584
    Product Code
    OQU
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 25, 2024
    Posted
    April 19, 2024
    Address
    12220 N Meridian St, Ste 150, Carmel, IN, 46032-6972

    Description

    AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.

    Reason

    Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.

    Action

    An Urgent Medical Device Recall notification dated 3/25/2024 was mailed to consignees via UPD notifying them of this SonarMed Sensor and Monitor recall. Consignees were asked to discontinue use of affected devices, quarantine any affected devices, and return all quarantined devices to Medtronic by obtaining a Returned Goods Authorization (RGA) from [email protected]. If product was purchased through a distributor the distributor can arrange for return. The provided notification is to be provided to those within consignee organizations that need to be made aware and if product was further distributed. Consignees with questions are to contact customer service at 800-962-9888, Option 2.

    Distribution

    _AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA_

    Quantity

    145 units