Model note · Ventilator
Maquet Servo-u ventilator system 4.x
Servo-u is Getinge's touchscreen intensive care ventilator for neonatal, paediatric and adult patients. It follows the long running Servo-i, and many of its modules can be swapped with Servo-n and Servo-i units. A patient unit mixes and delivers gas, while a separate user interface handles settings and monitoring. It offers NAVA driven by the diaphragm's electrical activity, and a reusable expiratory cassette with an ultrasonic flow sensor.
The model
Maker, model and type.
- Maker
- Maquet Critical Care AB (Getinge)
- Model
- Servo-u ventilator system 4.x (model 66 94 800; sister models Servo-n 66 88 600 and Servo-u MR 68 88 800)
- Device type
- Ventilator
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Tidal volume range | Neonatal 2 to 50 mL; paediatric 10 to 400 mL; adult 100 to 4000 mL | Source |
| Maximum inspiratory flow | 33 L/min neonatal, 100 L/min paediatric, 200 L/min adult | Source |
| Pressure ranges | PEEP 0 to 50 cmH2O; pressure above PEEP 0 to 80 cmH2O (0 to 120 cmH2O adult) | Source |
| Respiratory rate | 4 to 150 breaths/min neonatal and paediatric; 4 to 100 breaths/min adult | Source |
| Batteries | 2 to 6 hot swappable battery modules (2 included); at least 3 hours back up with 6 batteries | Source |
| Size and weight | Patient unit 300 x 205 x 420 mm; about 23 kg (patient unit 15 kg, user interface 4 kg), about 35 kg with mobile cart | Source |
| Display | 15 inch TFT LCD touchscreen | Source |
| O2 measurement | Permanent O2 sensor or consumable O2 cell | Source |
| FDA classification | Continuous ventilator, facility use, 21 CFR 868.5895, Class II, product code CBK; K201874 (4.1) decided 20 April 2021 | Source |
| Servo-u MR conditions | For use with 1.5 T or 3 T scanners, kept outside fields above 20 mT (200 gauss); has a magnetic field indicator | Source |
Recalls
Known FDA recalls.
- Z-2963-20262026-06-30
Y sensor module missing production electrical safety testing.
FDA record - Z-2013-20252025-05-30
Possible inaccurate circuit compliance from extended leakage test with an incorrect active humidifier (Z-2014 and Z-2015 cover Servo-n and Servo-u MR).
FDA record - Z-1560-20222022-07-20
Alarm combinations could cause loss of communication and loss of ventilation; fixed in software 4.4.
FDA record
Safety
Safety warnings from the record.
- If ventilation stops from the alarm combination fault, hypoventilation and hypoxic injury can follow; never leave the patient unattended and keep a manual resuscitator ready. Source
- If the circuit is changed without a new circuit test, delivered volume is wrong in volume modes and measured volume is wrong in pressure modes. Source
- Circuit compliance could be measured wrongly when the extended leakage test is combined with an unsuitable active humidifier. Source
Sources
Where this note comes from.
- Getinge Servo-u product page
- Getinge Servo-u product brochure
- Getinge Servo-u 4.1 startup guide
- FDA 510(k) K201874 summary, Servo-u/n/u MR 4.1
- openFDA recall search, Servo-u
- openFDA MAUDE problem counts, brand SERVO-U
Not covered: The Servo-u service manual and full alarm list are not public; only alarms named in Getinge's startup guide and the FDA summary are listed. FDA recall records give conflicting model numbers for Servo-u and Servo-n (6694800 and 6688600 swapped between records); the 510(k) numbers are used here. The product page was not opened directly; figures come from the brochure. MAUDE counts are reports, not failure rates. Recall text was read through openFDA because FDA recall pages returned errors at drafting time.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.