BEUDAMED
    FDA Enforcement Class I Ongoing

    Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.

    Recall: Z-0708-2025 · Reported January 1, 2025

    Enforcement

    Recall Number
    Z-0708-2025
    Event ID
    95837
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Braemar Manufacturing, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2025
    Initiation Date
    December 18, 2024
    Classification Date
    December 23, 2024
    Address
    3890 Murphy Canyon Rd Ste 100, San Diego, CA, 92123-4448, United States

    Description

    Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.

    Reason

    Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.

    Code Info

    Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4

    Distribution

    US Nationwide distribution including PR.

    Quantity

    ~130,000 with 41,282 customers (1 software copy used)