Z-2015-2025 Class I Ongoing
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.