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NOX MEDICAL recalls Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Recalled October 13, 2021 · FDA recall Z-0031-2022 · NOX MEDICAL
Hazard
Error in the device firmware results in the inaccurate detection of device position. · FDA Class II
Units
128 units
Sold at
US Nationwide distribution in the states of OH, IL, GA, IA, CA, PA, NM, MI, SD.
Description
Error in the device firmware results in the inaccurate detection of device position.
Product
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Manufacturer(s)
NOX MEDICAL
Made in
Iceland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →