FDA Medical Device Recalls (openFDA)
Maquet Critical Care AB: Servo-n Ventilator System. Model Number: 6694800.
- Recall number
- Z-2014-2025
- Recalling firm
- Maquet Critical Care AB
- Product
- Servo-n Ventilator System. Model Number: 6694800.
- Status
- Open, Classified
- Initiated
- 2025-05-30
- Posted
- 2025-06-27
- Terminated
- not on file
- 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 and to individuals if units were transferred. Additionally, consignees were requested to complete and return the provided response form.
- Quantity
- 7,688 units
- Distribution
- US Nationwide distribution and Puerto Rico. No international distribution.
- Lot, serial or model codes
- Model Number: 6694800. UDI-DI: 07325710001110. All software versions.
- 510(k) numbers
- ["K201874"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3002808128
- Firm city
- Solna
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28