Maquet Critical Care AB: Device Recall
Recall #Z-2014-2025 · 05/30/2025
Class I: Dangerous
Recall Details
- Recall Number
- Z-2014-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Maquet Critical Care AB
- Status
- Ongoing
- Date Initiated
- 05/30/2025
- Location
- Solna, Sweden
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,688 units
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.
Product Description
Servo-n Ventilator System. Model Number: 6694800.
Distribution Pattern
US Nationwide distribution and Puerto Rico. No international distribution.
Other Recalls by Maquet Critical Care AB
- Class I: Dangerous 05/30/2025
- Class I: Dangerous 05/30/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.