SDMS (SenTec Digital Monitoring System)
Reported: October 26, 2016 Initiated: September 15, 2016 #Z-0088-2017
Product Description
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).
Details
- Recalling Firm
- SenTec AG
- Units Affected
- 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.
- Location
- Therwil, N/A
Frequently Asked Questions
What product was recalled? ▼
SDMS (SenTec Digital Monitoring System). Recalled by SenTec AG. Units affected: 75 (54 US; 21 =OUS).
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 26, 2016. Severity: Moderate. Recall number: Z-0088-2017.
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