Servo-n Ventilator System. Model Number: 6694800 recallZ-2014-2025 · Maquet Critical Care AB · initiated May 30, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Critical Care AB or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2014-2025
- Status
- Open, Classified
- Initiated by the company
- May 30, 2025
- Posted by the FDA
- Jun 27, 2025
- Recalling firm
- Maquet Critical Care AB
- Quantity
- 7,688 units
- Product code
- CBK
- FDA submissions
- K201874
- Distribution
- US Nationwide distribution and Puerto Rico. No international distribution.
Product description
Servo-n Ventilator System. Model Number: 6694800.
Code information (models, lots, serial numbers)
Model Number: 6694800. UDI-DI: 07325710001110. All software versions.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BASE UNIT SERVO-U 6694800Maquet Critical Care AB · Ventilator, Continuous, Facility Use1 recall4 deaths655 reports
Other devices under the same FDA submission
2 devices cleared under K201874 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Base Unit SERVO-n 6688600Maquet Critical Care AB · Ventilator, Continuous, Facility Use1 recall1 death104 reports
- Base Unit Servo-u MR 6888800Maquet Critical Care AB · Ventilator, Continuous, Facility Use1 recall6 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97032).
- Z-2013-2025 · Open, ClassifiedServo-u Ventilator System. Model Number: 6688600.
- Z-2015-2025 · Open, ClassifiedServo-u MR Ventilator System. Model Number: 6888800.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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