FDA Medical Device Recalls (openFDA)
Maquet Critical Care AB: GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use
- Recall number
- Z-2963-2026
- Recalling firm
- Maquet Critical Care AB
- Product
- GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use
- Status
- Open, Classified
- Initiated
- 2026-06-30
- Posted
- 2026-08-14
- Terminated
- not on file
- Reason
- 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
- 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 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).
- Quantity
- 9 units
- Distribution
- US Nationwide distribution in the states of CA, GA, MN, NY.
- Lot, serial or model codes
- DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.
- 510(k) numbers
- ["K201874"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3002808128
- Firm city
- Solna
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28