FDA Device recall Z-0088-2017
SDMS (SenTec Digital Monitoring System)
- FDA Device
- Class II
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class II recall of SDMS (SenTec Digital Monitoring System) by Sentec Ag, citing 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 circum….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0088-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-15 |
| Published | 2016-10-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sentec Ag |
| Distribution | LA, MI, MO, OH, TN |
Product
SDMS (SenTec Digital Monitoring System)
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).
Identifiers
| code_info | SN 306497 to SN 306571. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0088-2017%22
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