Servo-n ventilators may measure patient circuit compliance inaccurately
The Servo-n Ventilator System is being recalled because patient circuit compliance may be measured inaccurately during the patient circuit test. 7,688 units affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death or injury is reported in the source, so it does not escalate to Critical.
Plain-English summary
The Servo-n Ventilator System, model number 6694800, UDI-DI 07325710001110, from Maquet Critical Care AB, is being recalled across all software versions. The action covers 7,688 units.
The stated reason is the potential for inaccurate measurement of the patient circuit compliance during the patient circuit test, due to a combination of an incorrect pre-use leakage test and use of an incorrect active humidifier. The FDA classified the action as Class I, its most serious classification.
Distribution was nationwide in the United States and Puerto Rico, with no international distribution.
Facilities should identify affected units using the model number and UDI-DI above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Servo-n Ventilator System. Model Number: 6694800.
- Manufacturer
- Maquet Critical Care AB
- Category
- Medical Device — Ventilator
- Hazard
- circuit-compliance
- measurement-error
- ventilator
- class-i
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: 6694800. UDI-DI: 07325710001110. All software versions.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereAbiomed Impella Introducer Kit recalled for potential fluid leakage
FDA (Devices) · 2026-07-22
- ModerateMedline Kits with Zimmer Biomet Mixing Bowls and Spatulas Recalled
FDA (Devices) · 2026-07-22
- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- LowRio II Nasal Pillows Interface Packaging and Labeling Discrepancy Recall
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22