Z-2015-2025 Class I Ongoing

Recalled by Maquet Critical Care AB — Solna

Recall Details

Product Type
Devices
Report Date
July 9, 2025
Initiation Date
May 30, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
129 units

Product Description

Servo-u MR Ventilator System. Model Number: 6888800.

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 Pattern

US Nationwide distribution and Puerto Rico. No international distribution.

Code Information

Model Number: 6888800. UDI-DI: 07325710010518. All software versions.