FDA-Device2025-07-09Class I
Servo-u Ventilator System. Model Number: 6688600.
Maquet Critical Care AB
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.
Sold states
US Nationwide distribution and Puerto Rico. No international distribution.
Affected count
874 units
Manufactured in
Rontgenvagen 2, Solna, Sweden
Products
Servo-u Ventilator System. Model Number: 6688600.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2013-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief