Servo-u MR Ventilator (Maquet) – Patient Circuit Test Error (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Servo-u MR Ventilator System. Model Number: 6888800.
Brand
Maquet Critical Care AB Rontgenvagen
Lot Codes / Batch Numbers
Model Number: 6888800. UDI-DI: 07325710010518. All software versions.
Products Sold
Model Number: 6888800. UDI-DI: 07325710010518. All software versions.
Maquet Critical Care AB Rontgenvagen is recalling Servo-u MR Ventilator System. Model Number: 6888800. due to Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026