Maquet Critical Care AB: Servo-n Ventilator System. Model Number: 6694800.

Hazard

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.

Details from the source

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. Distribution: US Nationwide distribution and Puerto Rico. No international distribution. Quantity: 7,688 units Lot/code info: Model Number: 6694800. UDI-DI: 07325710001110. All software versions.

UPC codes

07325710001110

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.