GETINGE Y SENSOR Module recall (Maquet Critical Care AB)
Medical deviceClass IIOngoing
Summary: Maquet Critical Care AB is recalling GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.. Reason: The module did not undergo electrical safety tests and functional tests during production.
What is being recalled
GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.
Why
The module did not undergo electrical safety tests and functional tests during production.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of CA, GA, MN, NY. (states named: California, Georgia, Minnesota, New York)
How to tell if yours is affected
DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2963-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 30, 2026 |
| Reported | August 26, 2026 |
| Company | Maquet Critical Care AB |
| Company location | Solna, Sweden |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 9 units |
More recalls from Maquet Critical Care AB · all medical device recalls · recalls from June 2026