FDA Device recall Z-2015-2025
Servo-u MR Ventilator System
- FDA Device
- Class I
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class I recall of Servo-u MR Ventilator System by Maquet Critical Care Ab, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2015-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-05-30 |
| Published | 2025-07-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Maquet Critical Care Ab |
| Distribution | US |
Product
Servo-u MR Ventilator System. Model Number: 6888800.
Reason
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.
Identifiers
| code_info | Model Number: 6888800. UDI-DI: 07325710010518. All software versions. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2015-2025%22
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