Recall Z-2014-2025 ยท CBK Ventilator, Continuous, Facility Use
Maquet Critical Care AB
Servo-n Ventilator System. Model Number: 6694800.
| Date | Jun 27, 2025 (initiated May 30, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by 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 an |
| Quantity | 7,688 units |
| Distribution | US Nationwide distribution and Puerto Rico. No international distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201874 | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 Maquet Critical Care AB, Apr 20, 2021 |