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Recall Observatory FDA recall evidence

Device product

Servo-n Ventilator System. Model Number: 6694800.

Z-2014-2025

May 30, 2025

Class I

Product summary

Firm
Maquet Critical Care AB
Event
Event 97032
Status
Ongoing
Classification
Class I
Quantity
7,688 units
Official record key
device-enforcement:Z-2014-2025

Official wording

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.

Code information: Model Number: 6694800. UDI-DI: 07325710001110. All software versions.

Distribution pattern: US Nationwide distribution and Puerto Rico. No international distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.