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U.S. Department of Health and Human Services

Class 1 Device Recall Servou

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 Class 1 Device Recall Servousee related information
Date Initiated by FirmMay 30, 2025
Date PostedJune 27, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2013-2025
Recall Event ID 97032
510(K)NumberK201874 
Product Classification Ventilator, continuous, facility use - Product Code CBK
ProductServo-u Ventilator System. Model Number: 6688600.
Code Information Model Number: 6688600. UDI-DI: 07325710001042. All software versions.
Recalling Firm/
Manufacturer		 Maquet Critical Care AB
Rontgenvagen 2
Solna Sweden
Manufacturer 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 2		Under Investigation by firm
ActionMaquet 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 in Commerce874 units
DistributionUS Nationwide distribution and Puerto Rico. No international distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CBK
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