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.

Class II

Recalling firm: Maquet Critical Care AB
Reason for recall: The module did not undergo electrical safety tests and functional tests during production.
Affected products (lot / model / serial): DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.
Units affected: 9 units
Distribution pattern: US Nationwide distribution in the states of CA, GA, MN, NY.
Firm location: Solna, Sweden
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-2963-2026
Recall initiated: June 30, 2026
FDA classification date: August 14, 2026
FDA report date: August 26, 2026
FDA event ID: 99439
Last updated on HTM Vibe: September 8, 2026