FDAFDA recall Z-2963-2026 · Aug 26, 2026
Maquet Critical Care AB: GETINGE Y SENSOR Module recall
Recall found
Product
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 for recall
The module did not undergo electrical safety tests and functional tests during production.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.
- Quantity
- 9 units
- Distribution
- US Nationwide distribution in the states of CA, GA, MN, NY.
- Recalling firm
- Maquet Critical Care AB, Solna
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-30
Source: openFDA enforcement record Z-2963-2026 · search recall number Z-2963-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.