Class II — SenTec AG
| Recalling firm | Sentec, Inc. |
|---|---|
| Registered facility | SENTEC, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards. |
| Product | SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor 2 or OxiVenT sensor). |
| Quantity | 15 devices |
| Distribution | IL, PA, FL, NJ, GA, MA |
| Initiated | 2020-12-10 |
| Classified | 2021-02-18 |
| Terminated | 2026-08-31 |
| Recall number | Z-1134-2021 |
| 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 — SenTec AG (Z-1134-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87054/
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