FDA-Device2016-10-26Class II
SDMS (SenTec Digital Monitoring System)
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).
Sold states
Worldwide Distribution - US Distribution to the states of : LA, MI, MO, OH, TN. and to the countries of : United Kingdom, The Netherlands and Australia.
Affected count
75 (54 US; 21 =OUS)
Manufactured in
Ringstrasse 39, N/A, Therwil, N/A, Switzerland
Products
SDMS (SenTec Digital Monitoring System)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0088-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief