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Maquet Critical Care AB: GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maqu

Medical DevicesSource: FDA (device) · Date: 2026-08-26

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Maquet Critical Care AB
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 / hazard
The module did not undergo electrical safety tests and functional tests during production.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of CA, GA, MN, NY.
Recall initiated
2026-06-30
Code info
DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.
Product quantity
9 units
Voluntary mandated
Voluntary: Firm initiated
City
Solna
Country
Sweden
Event id
99439
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