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U.S. Department of Health and Human Services

Class 2 Device Recall GETINGE Y SENSOR Module, SERVOU, SERVON

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 Class 2 Device Recall GETINGE Y SENSOR Module, SERVOU, SERVONsee related information
Date Initiated by FirmJune 30, 2026
Date PostedAugust 14, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2963-2026
Recall Event ID 99439
510(K)NumberK201874 
Product Classification Ventilator, continuous, facility use - Product Code CBK
ProductGETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use
Code Information DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.
FEI Number 3002808128
Recalling Firm/
Manufacturer		 Maquet Critical Care AB
Rontgenvagen 2
Solna Sweden
Manufacturer Reason
for Recall		Maquet Critical Care AB, a subsidiary of Getinge, is voluntarily recalling Y sensor module, part of the SERVO-U/-N ventilator system, due to missing production safety electrical testing.
FDA Determined
Cause 2		Under Investigation by firm
ActionGetinge issued an URGENT MEDICAL DEVICE CORRECTION notice was issued to its consignees on 7/9/2026 via FedEx. The notice explained the issue, potential risk to health, and requested the following: "Prior to the replacement, Getinge requests that you take the following actions: 1. Ensure all affected product in your inventory has been identified. 2. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. 3. Contact Technical Service if you have questions at 888-943-8872 (888 9GETUSA), Option 4, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). 4. Complete and return the enclosed response form to Getinge by e-mailing a copy to recallresponses.qrc@getinge.com. For questions regarding this communication, please contact contact Technical Service if you have any questions at 888-943-8872 (888 9GETUSA), Option 4, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Quantity in Commerce9 units
DistributionUS Nationwide distribution in the states of CA, GA, MN, NY.
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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