GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number… recallZ-2963-2026 · Maquet Critical Care AB · initiated Jun 30, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Critical Care AB or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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).
Recall details
- Recall number
- Z-2963-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 30, 2026
- Posted by the FDA
- Aug 14, 2026
- Recalling firm
- Maquet Critical Care AB
- Quantity
- 9 units
- Product code
- CBK
- FDA submissions
- K201874
- Distribution
- US Nationwide distribution in the states of CA, GA, MN, NY.
Product description
GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use
Code information (models, lots, serial numbers)
DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Y sensor module, SERVO-U/-n 6693662Maquet Critical Care AB · Ventilator, Continuous, Facility Use1 recall0 reports
Other devices under the same FDA submission
3 devices cleared under K201874 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- BASE UNIT SERVO-U 6694800Maquet Critical Care AB · Ventilator, Continuous, Facility Use1 recall4 deaths655 reports
- Base Unit SERVO-n 6688600Maquet Critical Care AB · Ventilator, Continuous, Facility Use1 recall1 death104 reports
- Base Unit Servo-u MR 6888800Maquet Critical Care AB · Ventilator, Continuous, Facility Use1 recall6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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