FDA recall Z-2014-2025

Maquet Critical Care AB · Class I · device

Product

Servo-n Ventilator System. Model Number: 6694800.

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.

Key facts

Status: Ongoing
Initiation date: 2025-05-30
Report date: 2025-07-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Solna, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2014-2025