Maquet Critical Care AB recalls Servo-u MR Ventilator System. Model Number: 6888800.
- Recall date
- May 30, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2015-2025
- FDA classification
- Class I
- Brand / firm
- Maquet Critical Care AB
- Sold / distributed
- US Nationwide distribution and Puerto Rico. No international distribution.
Why it was recalled
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.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Servo-u MR Ventilator System. Model Number: 6888800.
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