GETINGE Y SENSOR Module — Class II medical device recall Z-2963-2026
Ongoing recall by Maquet Critical Care AB, reported 2026-08-26, distributed nationwide. The module did not undergo electrical safety tests and functional tests during production.
| Recall number | Z-2963-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Critical Care AB, Solna, Sweden |
| Recall initiated | 2026-06-30 |
| Classified | 2026-08-14 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 9 units |
| UPC / GTIN / UDI-DI | 07325710000304 |
| Lot numbers | 21049, 21088, 21089, 21093, 21100, 21103, 21108, 21114, 21115 |
| Model numbers | 6693662 |
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 for recall
The module did not undergo electrical safety tests and functional tests during production.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2963-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.