SenTec — Class II medical device recall Z-2199-2012
Terminated recall by Sentec AG, reported 2012-08-22, distributed nationwide. SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing du
| Recall number | Z-2199-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sentec AG, Therwil, Baselland, Switzerland |
| Recall initiated | 2012-07-09 |
| Classified | 2012-08-13 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2012-10-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, DE, ES, FR, NL, TH |
| Quantity | 8 |
Product
SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).
Reason for recall
SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.
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-2199-2012. 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.