Recall Z-2015-2025— Maquet Critical Care AB

Name: FDA recall Z-2015-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-30

Class I · Ongoing

Class I FDA medical device recall by Maquet Critical Care AB, initiated 2025-05-30. It names one FDA 510(k) clearance: K201874. Product: Servo-u MR Ventilator System. Model Number: 6888800.. Reason: Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier..

Recalling firm: Maquet Critical Care AB
Classification: Class I
Status: Ongoing
Initiated: 2025-05-30
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

Servo-u MR Ventilator System. Model Number: 6888800.

Reason for recall

Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.

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