Maquet Critical Care Ab: Ventilator, Continuous, Facility Use
Recall Summary Maquet Critical Care AB is recalling the Y sensor module used in SERVO-U and SERVO-N ventilators because the component did not undergo required safety electrical testing during manufacturing. The recalled devices were distributed nationwide to healthcare facilities. Users of these ventilator systems should check whether their equipment includes the affected Y sensor module (Model Number 6693662).
- Recalling firm
- Maquet Critical Care AB
- Product
- GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-30
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of CA, GA, MN, NY.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ab3ccf6d-83fe-4656-9482-645ca59331f5