# FDA recall Z-2015-2025

> **Maquet Critical Care AB** · Class I · device recall initiated 2025-05-30.

## Product

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

US Nationwide distribution and Puerto Rico. No international distribution.

## Key facts

- **Recall number:** Z-2015-2025
- **Recalling firm:** Maquet Critical Care AB
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-30
- **Report date:** 2025-07-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Solna, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2015-2025

## Citation

> AI Analytics. FDA recall Z-2015-2025. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2015-2025. Source: US FDA. Licensed CC0.

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