Recall Z-2014-2025
Maquet Critical Care AB · initiated May 30, 2025
Class I – dangerous or defective products that could cause serious health problems or death
Product
Servo-n Ventilator System. Model Number: 6694800.
Codes / lots: Model Number: 6694800. UDI-DI: 07325710001110. All software versions.
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.
FDA-determined 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.
Details
- Recall number
- Z-2014-2025
- Initiated
- May 30, 2025
- Posted by FDA
- June 27, 2025
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Quantity
- 7,688 units
- Distribution
- US Nationwide distribution and Puerto Rico. No international distribution.
- Recalling firm
- Maquet Critical Care AB, Solna
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2013-2025 Class I | Servo-u Ventilator System. Model Number: 6688600.Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due… | 05/30/2025Open, Classified |
| Z-2015-2025 Class I | Servo-u MR Ventilator System. Model Number: 6888800.Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due… | 05/30/2025Open, Classified |