Recall Z-0031-2022— NOX MEDICAL

Name: FDA recall Z-0031-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-07

Class II · Terminated

Class II FDA medical device recall by NOX MEDICAL, initiated 2021-09-07, terminated 2023-05-01. It names one FDA 510(k) clearance: K082113. Product: Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.. Reason: Error in the device firmware results in the inaccurate detection of device position..

Recalling firm: NOX MEDICAL
Classification: Class II
Status: Terminated
Initiated: 2021-09-07
Terminated: 2023-05-01
Firm location: Reykjavik, Iceland

510(k) clearances named in this recall

1 on FDA's record

K082113 — NOX T3, NOXTURNAL (PC APPLICATION)Nox Medical·cleared 2008-11-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.