FDA-Device2023-06-28Class II
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
SenTec AG
Hazard
The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.
Sold states
US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.
Affected count
11 in the U.S.
Manufactured in
Ringstrasse 39, Therwil, Switzerland
Products
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1980-2023Don't want to check this manually?
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