Maquet Critical Care Ab
ROENTGENVAGEN 2, SOLNA Stockholm, SE
Registered product codes
22 product codes
Recent MDR events
21,166 on file
- Servo-i Base UnitJul 31, 2026Malfunction8010042-2026-0001035
- Servo-s Base UnitJul 31, 2026Malfunction8010042-2026-0001036
- BASE UNIT SERVO-UJul 31, 2026Malfunction8010042-2026-0001037
- Servo-i Base UnitJul 31, 2026Malfunction8010042-2026-0001038
- Servo-s Base UnitJul 30, 2026Malfunction8010042-2026-0001027
- Servo-s Base UnitJul 30, 2026Malfunction8010042-2026-0001026
- Servo-air LiteJul 30, 2026Malfunction8010042-2026-0001028
- BASE UNIT SERVO-UJul 30, 2026Malfunction8010042-2026-0001030
- BASE UNIT SERVO-UJul 30, 2026Malfunction8010042-2026-0001029
- BASE UNIT SERVO-UJul 30, 2026Malfunction8010042-2026-0001033
Recalls
5 on file
- Open, ClassifiedAug 14, 2026
Maquet Critical Care AB, a subsidiary of Getinge, is voluntarily recalling Y sensor module, part of the SERVO-U/-N ventilator system, due to missing production safety electrical testing.
View FDA record ↗ - Open, ClassifiedAug 3, 2026
Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.
View FDA record ↗ - Open, ClassifiedJun 27, 2025
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.
View FDA record ↗ - Open, ClassifiedJun 27, 2025
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.
View FDA record ↗ - Open, ClassifiedJun 27, 2025
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.
View FDA record ↗
Compliance history
Matched by FEI 3002808128.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.