V-Sign Sensor 2 — Class II medical device recall Z-1980-2023
Ongoing recall by SenTec AG, reported 2023-06-28, distributed nationwide. The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the softwa
| Recall number | Z-1980-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SenTec AG, Therwil, Switzerland |
| Recall initiated | 2023-05-02 |
| Classified | 2023-06-20 |
| Reported by FDA | 2023-06-28 |
| Distributed | Nationwide (US) |
| Quantity | 11 in |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07640121880513 |
| Serial numbers | 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997 |
Product
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Reason for recall
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.
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-1980-2023. 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.