Servo-u Ventilator System. Model Number: 6688600.
FDA device recall Z-2013-2025 · posted 2025-06-27 · Open, Classified
Recall details
- Recalling firm
- Maquet Critical Care AB
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- CBK
- Quantity affected
- 874 units
- Distribution
- US Nationwide distribution and Puerto Rico. No international distribution.
- Date initiated
- 2025-05-30
- Date posted
- 2025-06-27
- Location
- Solna, Sweden
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 (K201874) | Maquet Critical Care AB | 2021-04-20 |