Maquet Critical Care AB recalls Servo-n Ventilator System. Model Number: 6694800.

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2014-2025
• FDA 510(k) clearance · K201874The device's official FDA premarket clearance record
• FDA device classification · CBKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5895The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Maquet Critical Care ABSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.