Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2014-2025 — Servo-n Ventilator System. Model Number: 6694800.

U.S. FDA — Device Enforcement · Sweden · 2025-05-30 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2014-2025
Date of alert
2025-05-30
Country / jurisdiction
Sweden
Risk level
Class I
Risk type
recall
Brand
Maquet Critical Care AB
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07325710001110
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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