Servo-u Ventilator System Recalled for Inaccurate Patient Circuit Compliance Measurement
Maquet Critical Care's Servo-u Ventilator System is recalled due to potential inaccurate measurement of patient circuit compliance during testing. The issue results from incorrect pre-use leakage tests and use of an incompatible humidifier.
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: This is an FDA Class I recall affecting a critical life-support device. The rubric establishes that FDA Class I recalls must score at least 4. No illnesses or injuries are reported in the source text, precluding a score of 5, but the measurement error in a ventilator system poses an inherent patient safety risk.
Plain-English summary
Maquet Critical Care AB is recalling the Servo-u Ventilator System, Model 6688600, due to a potential measurement error affecting patient circuit compliance testing. The device may provide inaccurate measurements during patient circuit testing as a result of an incorrect pre-use leakage test procedure combined with use of an incorrect active humidifier.
The recall affects 874 units distributed nationwide in the United States and Puerto Rico. All software versions of this model are included in the recall.
Healthcare facilities using this ventilator should verify their equipment and testing procedures. Patients and caregivers relying on this device should consult with their healthcare providers about the potential impact of measurement inaccuracies on their treatment protocols and care management.
The recalled product
- Product
- Servo-u Ventilator System. Model Number: 6688600.
- Manufacturer
- Maquet Critical Care AB
- Hazard
- inaccurate-measurement
- ventilator-malfunction
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: 6688600. UDI-DI: 07325710001042. All software versions.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03