FDA Medical devices recall ·
GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662 recall
- Recall number
- Z-2963-2026
- Date
- (initiated June 30, 2026)
- Company / brand
- Maquet Critical Care AB
Rontgenvagen 2, Solna, Sweden - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 9 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
The module did not undergo electrical safety tests and functional tests during production.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.
Distribution
US Nationwide distribution in the states of CA, GA, MN, NY.
States: California Georgia Minnesota New York
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2963-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.