Z-2015-2025Class I

Servo-u MR Ventilator System. Model Number: 6888800

Name: Z-2015-2025 Servo-u MR Ventilator System. Model Number: 6888800
Creator: Maquet Critical Care AB
Published: 2025-05-30
License: https://open.fda.gov/license/

Maquet Critical Care AB / initiated 2025-05-30 / Open, Classified

FDA source

Maquet Critical Care AB began a recall of Servo-u MR Ventilator System. Model Number: 6888800 on 2025-05-30. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2015-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-05-30
Posted: 2025-06-27
Recalling firm: Maquet Critical Care AB
Product: Servo-u MR Ventilator System. Model Number: 6888800.
Product code: CBK Ventilator, Continuous, Facility Use
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.
FDA root cause: Under Investigation by firm
Action: Maquet Critical Care AB, a subsidiary of Getinge, notified consignees on about 05/30/2025 via FedEx letter. Consignees were instructed to configure all affected Servo ventilators with "Extended leakage test" set to "Off", per chapter 8.2.4 Configuration in the User's manuals and all users are recommended to follow the updated instructions for use of the User's manuals chapter 9.5.1 Patient circuit test, which is provided. Consignees are instructed to ensure all devices in inventory have been properly addressed as described above, to ensure the message is forwarded to all affected personnel and to individuals if units were transferred. Additionally, consignees were requested to complete and return the provided response form.
Quantity in commerce: 129 units
Distribution: US Nationwide distribution and Puerto Rico. No international distribution.
Product codes and lots: Model Number: 6888800. UDI-DI: 07325710010518. All software versions.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2015-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2013-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-06-27
Z-2014-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-06-27
Z-2015-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-06-27

Product code CBK

K201874Class IIServo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1Maquet Critical Care AB / cleared 2021-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)