Servo-n Ventilator System. Model Number: 6694800.
This recall is currently active, issued June 27, 2025. It was issued by Maquet Critical Care Ab Rontgenvagen.
- Recall Initiated
- May 30, 2025
- Posted
- June 27, 2025
- Recall Number
- Z-2014-2025
- Quantity
- 7,688 units
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution and Puerto Rico. No international distribution.
Lot / Code Info
Model Number: 6694800. UDI-DI: 07325710001110. All software versions.
Root Cause
Under Investigation by firm
Action Taken
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.