BEUDAMED
    FDA Enforcement Class II Ongoing

    IntelliVue G7m Anesthesia Gas Module, Product Number 866173

    Recall: Z-0007-2025 · Reported October 9, 2024

    Enforcement

    Recall Number
    Z-0007-2025
    Event ID
    95301
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2024
    Initiation Date
    January 18, 2023
    Classification Date
    October 1, 2024
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2296, United States

    Description

    IntelliVue G7m Anesthesia Gas Module, Product Number 866173

    Reason

    The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G7m's sample gas pump which could stop working, producing a technical, INOP (inoperable) alarm. The pump may fail prematurely when there is friction caused by an abrasion. This recall is for an IMPORTANT PRODUCT NOTICE dated 1/18/23.

    Code Info

    UDI-DI: 00884838051492; Serial Numbers: DE43800129 through DE43812627

    Distribution

    US Nationwide. Global Distribution.

    Quantity

    8,449 devices