BEUDAMED
    FDA Enforcement Class II Ongoing

    Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software

    Recall: Z-0571-2025 · Reported December 4, 2024

    Enforcement

    Recall Number
    Z-0571-2025
    Event ID
    95665
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LivaNova Deutschland GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2024
    Initiation Date
    October 18, 2024
    Classification Date
    November 27, 2024
    Address
    Lindberghstr. 25, Munich, N/A, Germany

    Description

    Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software

    Reason

    Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.

    Code Info

    UDI-DI: 04033817903062. Software Version: 1.5. Serial Numbers: 49PK00436, 49PK00108, 49PK00374, 49PK00479, 49PK00480, 49PK00481, 49PK00093, 49PK00091, 49PK00092, 49PK00163, 49PK00497, 49PK00498, 49PK00219, 49PK00223, 49PK00224, 49PK00225, 49PK00226, 49PK00241, 49PK00255, 49PK00292, 49PK00291, 49PK00293, 49PK00490, 49PK00487, 49PK00488, 49PK00278, 49PK00274, 49PK00277, 49PK00275, 49PK00276, 49PK00273, 49PK00457, 49PK00458, 49PK00459, 49PK00455, 49PK00456, 49PK00290, 49PK00288

    Distribution

    US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.

    Quantity

    38