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SenTec AG recalls SDMS (SenTec Digital Monitoring System)
Recalled October 26, 2016 · FDA recall Z-0088-2017 · SenTec AG
Hazard
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). · FDA Class II
Units
75 (54 US; 21 =OUS)
Sold at
Worldwide Distribution - US Distribution to the states of : LA, MI, MO, OH, TN. and to the countries of : United Kingdom, The Netherlands and Australia.
Description
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)
Manufacturer(s)
SenTec AG
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →