Base Unit Servo-u MR 6888800Recalls & reported problems
Maquet Critical Care AB · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07325710010518), received between Feb 26, 2024 and Jun 1, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Output Problem” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
4 other recalls cover devices cleared under the same FDA submission (K201874); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- May 30, 2025Open, Classified
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.
Z-2015-2025 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Output Problem3
- Unintended Collision2
- Failure of Device to Self-Test1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2026Unintended Collision; Output Problem
IT WAS REPORTED THAT VENTILATOR GENERATED TECHNICAL ERROR CODES INDICATING POWER ERROR AFTER APPROACHING TOO CLOSE TO MRI SCANNER. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25347211 ↗MalfunctionMar 24, 2026Failure of Device to Self-Test
Manufacturer's Ref. #:(b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24673367 ↗MalfunctionDec 12, 2025Unintended Collision; Unintended Collision
MANUFACTURER'S REF #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23788205 ↗MalfunctionNov 21, 2024Mechanical Problem; Mechanical Problem
MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20744124 ↗MalfunctionJul 16, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THE VENTILATOR GENERATED TECHNICAL ERROR CODES INDICATING DISABLED VALVES AND A PATIENT CATEGORY MISMATCH BETWEEN BREATHING AND MONITORING SUBSYSTEMS. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19749077 ↗MalfunctionFeb 26, 2024Output Problem; Output Problem
MANUFACTURER'S REF #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18775576 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K201874. One submission often covers many models, so check the product and lot details in each record.
- Z-2963-2026 · Jun 30, 2026 · Open, ClassifiedGETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use
- Z-2013-2025 · May 30, 2025 · Open, ClassifiedServo-u Ventilator System. Model Number: 6688600.
- Z-2014-2025 · May 30, 2025 · Open, ClassifiedServo-n Ventilator System. Model Number: 6694800.
- Z-1560-2022 · Jul 20, 2022 · Open, ClassifiedMaquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air
Other Ventilator, Continuous, Facility Use devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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