BEUDAMED
    FDA Recall Open, Classified

    IntelliVue G7m Anesthesia Gas Module, Product Number 866173

    Recall: Z-0007-2025 · Initiated January 18, 2023

    Recall

    Recall Number
    Z-0007-2025
    Event Number
    95301
    Firm
    Philips North America
    FEI Number
    3006648320
    Product Code
    DSI
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 18, 2023
    Posted
    October 1, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2296

    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.

    Action

    An IMPORTANT PRODUCT NOTICE dated 1/18/23 was sent to customers. The actions planned by Philips to correct the problem A Philips representative will reach out to you to arrange a replacement of the sample gas pump. Affected products and how to identify them Affected product is the 866173 lntelliVue G7m Anesthesia Gas Module. Both the product number and the serial number on the G7m product is contained on the back of the product, preceded by "REF" and "SN", respectively. If you need any further information or support concerning this issue, please contact your local Philips representative.

    Distribution

    US Nationwide. Global Distribution.

    Quantity

    8,449 devices