Device recall

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.

FDA recall source

Recall number

Z-2963-2026

Event id

99439

Status

Ongoing

FDA classification

Class II

Recalling firm

Maquet Critical Care AB

Report date

Aug 26, 2026

Initiated

Jun 30, 2026

Center classification date

Aug 14, 2026

Reason

The module did not undergo electrical safety tests and functional tests during production.

Quantity

9 units

Code info

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.

Voluntary or mandated

Voluntary: Firm initiated

Location

Solna, Sweden