BEUDAMED
    FDA Enforcement Class I Ongoing

    Servo-u MR Ventilator System. Model Number: 6888800.

    Recall: Z-2015-2025 · Reported July 9, 2025

    Enforcement

    Recall Number
    Z-2015-2025
    Event ID
    97032
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Maquet Critical Care AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2025
    Initiation Date
    May 30, 2025
    Classification Date
    June 27, 2025
    Address
    Rontgenvagen 2, Solna, N/A, Sweden

    Description

    Servo-u MR Ventilator System. Model Number: 6888800.

    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.

    Code Info

    Model Number: 6888800. UDI-DI: 07325710010518. All software versions.

    Distribution

    US Nationwide distribution and Puerto Rico. No international distribution.

    Quantity

    129 units