CLASS I ONGOING Device recall · Reported 9 Jul 2025 · FDA Enforcement Report
Servo-n Ventilator System recalled by Maquet Critical Care AB
Maquet Critical Care AB is recalling Servo-n Ventilator System, distributed nationwide in the US. The recall was initiated on 30 May 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2014-2025
- FDA event ID
- 97032
- Recalling firm
- Maquet Critical Care AB, Solna
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 30 May 2025
- FDA classified
- 27 Jun 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- CPAP & Ventilators
Timeline
| 30 May 2025 | Recall initiated by company | |
| 27 Jun 2025 | Classified by FDA | +28 days |
| 9 Jul 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Servo-n Ventilator System. Model Number: 6694800.
Where it was distributed
US Nationwide distribution and Puerto Rico. No international distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model Number: 6694800. UDI-DI: 07325710001110. All software versions.
Where was it sold?
US Nationwide distribution and Puerto Rico. No international distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 97032This product is part of a recall event; the main page for the event is Servo-u Ventilator System recalled by Maquet Critical Care AB.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Servo-u Ventilator System recalled by Maquet Critical Care AB | Maquet Critical Care AB | Labeling Errors | Nationwide | |
| CLASS I | Servo-u MR Ventilator System recalled by Maquet Critical Care AB | Maquet Critical Care AB | Labeling Errors | Nationwide |
More recalls from Maquet Critical Care AB
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS I | Servo-u MR Ventilator System recalled by Maquet Critical Care AB | Maquet Critical Care AB | Labeling Errors | Nationwide |
| Device | CLASS I | Servo-u Ventilator System recalled by Maquet Critical Care AB | Maquet Critical Care AB | Labeling Errors | Nationwide |
Other CPAP & Ventilators recalls
All 554| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |