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

FDA device recall Z-2963-2026 · posted 2026-08-14 · Open, Classified

Recall details

Recalling firm

Maquet Critical Care AB

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.

Action taken

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 recallresponses.qrc@getinge.com. 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).

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

CBK

Quantity affected

9 units

Distribution

US Nationwide distribution in the states of CA, GA, MN, NY.

Date initiated

2026-06-30

Date posted

2026-08-14

Location

Solna, Sweden

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