GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use
FDA Recall Z-2963-2026 · Posted 2026-08-14
Recalling FirmMaquet Critical Care AB
Recall StatusOpen, Classified
Product CodeCBK
Date Initiated2026-06-30
Product Quantity9 units
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.
Firm Action
Getinge 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
[email protected].
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).
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of CA, GA, MN, NY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.