FDA Device Recall Z-2013-2025

Maquet Critical Care AB

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Servo-u Ventilator System. Model Number: 6688600.

Lot / serial / GTIN: Model Number: 6688600. UDI-DI: 07325710001042. All software versions.

Quantity: 874 units

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.

Recall record

Recall number: Z-2013-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide distribution and Puerto Rico. No international distribution.
Recall initiated: 2025-05-30
Classified by FDA Center: 2025-06-27
FDA published: 2025-07-09
Recalling firm: Maquet Critical Care AB

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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