FDA recall Z-0031-2022

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-09-07

Report date

2021-10-13

Termination date

2023-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reykjavik, Iceland

Primary source

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