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SenTec AG recalls V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Recalled June 28, 2023 · FDA recall Z-1980-2023 · 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. · FDA Class II
Units
11 in the U.S.
Sold at
US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.
Description
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.
Product
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Manufacturer(s)
SenTec AG
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →