Z-2963-2026Class II

GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use

Name: Z-2963-2026 GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use
Creator: Maquet Critical Care AB
Published: 2026-06-30
License: https://open.fda.gov/license/

Maquet Critical Care AB / initiated 2026-06-30 / Open, Classified / root cause: manufacturing process

FDA source

Maquet Critical Care AB began a recall of GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use on 2026-06-30. FDA classified it as Class II and gives the reason as "Maquet Critical Care AB, a subsidiary of Getinge, is voluntarily recalling Y sensor module, part of the SERVO-U/-N ventilator system, due to missing production safety electrical testing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2963-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-30
Posted: 2026-08-14
Recalling firm: Maquet Critical Care AB
Product: GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Maquet Critical Care AB, a subsidiary of Getinge, is voluntarily recalling Y sensor module, part of the SERVO-U/-N ventilator system, due to missing production safety electrical testing.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Getinge issued an URGENT MEDICAL DEVICE CORRECTION notice was issued to its consignees on 7/9/2026 via FedEx. The notice explained the issue, potential risk to health, and requested the following: "Prior to the replacement, Getinge requests that you take the following actions: 1. Ensure all affected product in your inventory has been identified. 2. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. 3. Contact Technical Service if you have questions at 888-943-8872 (888 9GETUSA), Option 4, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). 4. Complete and return the enclosed response form to Getinge by e-mailing a copy to [email protected]. For questions regarding this communication, please contact contact Technical Service if you have any questions at 888-943-8872 (888 9GETUSA), Option 4, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Quantity in commerce: 9 units
Distribution: US Nationwide distribution in the states of CA, GA, MN, NY.
Product codes and lots: DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2963-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2963-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14

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 2026-09-12. View this recall on fda.gov (opens on fda.gov)