Class II — Maquet Critical Care AB
| Recalling firm | Maquet Critical Care AB |
|---|---|
| Registered facility | MAQUET CRITICAL CARE AB (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The module did not undergo electrical safety tests and functional tests during production. |
| 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. |
| Quantity | 9 units |
| Distribution | US Nationwide distribution in the states of CA, GA, MN, NY. |
| Initiated | 2026-06-30 |
| Classified | 2026-08-14 |
| Recall number | Z-2963-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Maquet Critical Care AB (Z-2963-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99439/
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