RecallRadar

FDA Device recall Z-2014-2025

Servo-n Ventilator System

On 2025-07-09 the FDA classified a Class I recall of Servo-n 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

AgencyFDA Device
Recall numberZ-2014-2025
ClassificationClass I
Statusongoing
Initiated2025-05-30
Published2025-07-09
Last updated2026-09-13 11:57 UTC
CompanyMaquet Critical Care Ab
DistributionUS

Product

Servo-n Ventilator System. Model Number: 6694800.

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_infoModel Number: 6694800. UDI-DI: 07325710001110. 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-2014-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.