SenTec Digital Monitor — Class II medical device recall Z-1134-2021
Terminated recall by SenTec AG, reported 2021-02-24, distributed in FL, GA, IL, MA, NJ, PA. Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to compl
| Recall number | Z-1134-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SenTec AG, Therwil, N/A, Switzerland |
| Recall initiated | 2020-12-10 |
| Classified | 2021-02-18 |
| Reported by FDA | 2021-02-24 |
| Terminated | 2026-08-31 |
| Distributed | FL, GA, IL, MA, NJ, PA |
| Quantity | 15 devices |
| Serial numbers | 303170, 311166, 311263, 311408 |
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).
Reason for recall
Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
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-1134-2021. 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.