Z-2963-2026 Class II Ongoing
FDA device recall Z-2963-2026 was initiated by Maquet Critical Care AB on June 30, 2026 and is designated Class II. Reason for recall: The module did not undergo electrical safety tests and functional tests during production. The recall status is ongoing. Affected quantity: 9 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2026
- Initiation Date
- June 30, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.
Reason for Recall
The module did not undergo electrical safety tests and functional tests during production.
Distribution Pattern
US Nationwide distribution in the states of CA, GA, MN, NY.
Code Information
DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.