Class II — SenTec AG
| Recalling firm | Sentec, Inc. |
|---|---|
| Registered facility | SENTEC, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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). |
| Product | SDMS (SenTec Digital Monitoring System) |
| Quantity | 75 (54 US; 21 =OUS) |
| Distribution | Worldwide Distribution - US Distribution to the states of : LA, MI, MO, OH, TN. and to the countries of : United Kingdom, The Netherlands and Australia. |
| Initiated | 2016-09-15 |
| Classified | 2016-10-17 |
| Terminated | 2017-06-23 |
| Recall number | Z-0088-2017 |
| 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-0088-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75257/
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