PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: October 13, 2021 Initiated: September 7, 2021 #Z-0031-2022

Product Description

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.

Details

Recalling Firm
NOX MEDICAL
Units Affected
128 units
Distribution
US Nationwide distribution in the states of OH, IL, GA, IA, CA, PA, NM, MI, SD.
Location
Reykjavik

Frequently Asked Questions

What product was recalled?
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.. Recalled by NOX MEDICAL. Units affected: 128 units.
Why was this product recalled?
Error in the device firmware results in the inaccurate detection of device position.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 13, 2021. Severity: Moderate. Recall number: Z-0031-2022.