Class II — SenTec AG
| Recalling firm | Sentec, Inc. |
|---|---|
| Registered facility | SENTEC, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode. |
| Product | V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS). |
| Quantity | 11 in the U.S. |
| Distribution | US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX. |
| Initiated | 2023-05-02 |
| Classified | 2023-06-20 |
| Recall number | Z-1980-2023 |
| 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-1980-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92355/
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