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

Recall date

September 7, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0031-2022

FDA classification

Class II

Brand / firm

NOX MEDICAL

Sold / distributed

US Nationwide distribution in the states of OH, IL, GA, IA, CA, PA, NM, MI, SD.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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