FDA-Device2021-10-13Class II

Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

NOX MEDICAL
Hazard

Error in the device firmware results in the inaccurate detection of device position.

Sold states
US Nationwide distribution in the states of OH, IL, GA, IA, CA, PA, NM, MI, SD.
Affected count
128 units
Manufactured in
Keldnaholt, Reykjavik, Iceland
Products
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0031-2022

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