Recall Z-2963-2026— Maquet Critical Care AB

Name: FDA recall Z-2963-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-30

Class II · Ongoing

Class II FDA medical device recall by Maquet Critical Care AB, initiated 2026-06-30. It names one FDA 510(k) clearance: K201874. 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: The module did not undergo electrical safety tests and functional tests during production..

Recalling firm: Maquet Critical Care AB
Classification: Class II
Status: Ongoing
Initiated: 2026-06-30
Firm location: Solna, Sweden

510(k) clearances named in this recall

1 on FDA's record

K201874 — Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1Maquet Critical Care AB·cleared 2021-04-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.