SDMS — Class II medical device recall Z-0088-2017
Terminated recall by SenTec AG, reported 2016-10-26, distributed in LA, MI, MO, OH, TN. Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is
| Recall number | Z-0088-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SenTec AG, Therwil, N/A, Switzerland |
| Recall initiated | 2016-09-15 |
| Classified | 2016-10-17 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2017-06-23 |
| Distributed | LA, MI, MO, OH, TN |
| Countries outside the US | AU, GB, NL |
| Reason classes | device malfunction |
Product
SDMS (SenTec Digital Monitoring System)
Reason for recall
Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator).
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-0088-2017. 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.