BEUDAMED
    FDA Recall Open, Classified

    Servo-n Ventilator System. Model Number: 6694800.

    Recall: Z-2014-2025 · Initiated May 30, 2025

    Recall

    Recall Number
    Z-2014-2025
    Event Number
    97032
    Firm
    Maquet Critical Care AB Rontgenvagen
    FEI Number
    3002808128
    Product Code
    CBK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 30, 2025
    Posted
    June 27, 2025
    Address
    2 Solna Sweden

    Description

    Servo-n Ventilator System. Model Number: 6694800.

    Reason

    Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.

    Action

    Maquet Critical Care AB, a subsidiary of Getinge, notified consignees on about 05/30/2025 via FedEx letter. Consignees were instructed to configure all affected Servo ventilators with "Extended leakage test" set to "Off", per chapter 8.2.4 Configuration in the User's manuals and all users are recommended to follow the updated instructions for use of the User's manuals chapter 9.5.1 Patient circuit test, which is provided. Consignees are instructed to ensure all devices in inventory have been properly addressed as described above, to ensure the message is forwarded to all affected personnel and to individuals if units were transferred. Additionally, consignees were requested to complete and return the provided response form.

    Distribution

    US Nationwide distribution and Puerto Rico. No international distribution.

    Quantity

    7,688 units