FDA recall, , Moderate risk
Getinge Y Sensor Module, Servo-U, Servo-N
The module did not undergo electrical safety tests and functional tests during production.
Summary by Recall Canary from the FDA notice
What happened
Maquet Critical Care AB, a subsidiary of Getinge, is voluntarily recalling the Getinge Y Sensor Module, SERVO-U, SERVO-N, Model Number 6693662, part of the SERVO-U/-N continuous ventilator system, because the module did not undergo electrical safety tests and functional tests during production. The recall began June 30, 2026, and was added to the FDA's Enforcement Report on August 14, 2026.
The recalled modules were distributed in the states of California, Georgia, Minnesota and New York. The company recalled 9 units.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number, UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Getinge Y Sensor Module, Servo-U, Servo-N
- Model number
- 6693662
- UDI-DI
- 07325710000304
- Lot code
- 21049
- 21088
- 21089
- 21093
- 21100
- 21103
- 21108
- 21114
- 21115
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of California, Georgia, Minnesota, New York.
- Company
- Maquet Critical Care ABSolna, Sweden
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99439
- Recall number
- Z-2963-2026
- Quantity recalled
- 9 units
All recalls from Maquet Critical Care AB
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
