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Open, Classified

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

FDA Recall Z-2015-2025 · Posted 2025-06-27

Recalling FirmMaquet Critical Care AB
Recall StatusOpen, Classified
Product CodeCBK
Date Initiated2025-05-30
Product Quantity129 units

Reason for Recall

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.

Firm 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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution and Puerto Rico. No international distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1Maquet Critical Care AB · 2021-04-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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