FDA Device recall Z-2963-2026
GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662
- FDA Device
- Class II
- ongoing
- Published 2026-08-26
On 2026-08-26 the FDA classified a Class II recall of GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662 by Maquet Critical Care Ab, citing the module did not undergo electrical safety tests and functional tests during production.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2963-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-30 |
| Published | 2026-08-26 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Maquet Critical Care Ab |
| Distribution | US |
Product
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
The module did not undergo electrical safety tests and functional tests during production.
Identifiers
| code_info | DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2963-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.