The Recall Desk
SevereFDA (Devices)·Z-2014-2025·Announced 2025-07-09

Servo-n Ventilator System recalled for patient circuit compliance measurement inaccuracy

Maquet Critical Care AB is recalling the Servo-n Ventilator System (Model 6694800) due to potential inaccurate measurement of patient circuit compliance caused by incorrect pre-use leakage test procedures and use of incorrect active humidifier equipment.

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 classification indicates the device presents a serious risk to patient health. While no reported illnesses or injuries have been documented, the potential for measurement inaccuracy in critical care equipment and the Class I designation support a Severe rating.

Plain-English summary

The Servo-n Ventilator System Model 6694800, manufactured by Maquet Critical Care AB, is being recalled due to the potential for inaccurate measurement during patient circuit compliance testing. This inaccuracy may result from a combination of incorrect pre-use leakage test procedures and the use of an incorrect active humidifier.

Approximately 7,688 units have been distributed nationwide in the United States and Puerto Rico. Healthcare facilities and individuals using this equipment should contact Maquet Critical Care AB for specific guidance and recommended corrective actions.

The recalled product

Product
Servo-n Ventilator System. Model Number: 6694800.
Manufacturer
Maquet Critical Care AB
Category
Medical Device — Respiratory Equipment
Hazard
  • measurement-error
  • incorrect-procedure

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