FDA Device recall Z-0031-2022
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep
- FDA Device
- Class II
- terminated
- Published 2021-10-13
On 2021-10-13 the FDA classified a Class II recall of Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep by Nox Medical, citing error in the device firmware results in the inaccurate detection of device position.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0031-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-07 |
| Published | 2021-10-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Nox Medical |
| Distribution | US |
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.
Identifiers
| code_info | Catalog Number: 561111; UDI: (01)15694311111443; Serial Numbers: 300106423, 300106426, 300106420, 300106419, 300106422,…Catalog Number: 561111; UDI: (01)15694311111443; Serial Numbers: 300106423, 300106426, 300106420, 300106419, 300106422, 300106427, 300106425, 300106424, 300106421, 300106477, 300106485, 300106783, 300106806, 300106841, 300106843 , 300106846, 300106848, 300106852, 300106853, 300106857, 300106862, 300106881, 300106882, 300106883, 300106884, 300106885, 300106886, 300106888, 300106889, 300106890, 300106894, 300106897, 300106912, 300107004, 300106385, 300106396, 300106397, 300106407, 300106413, 300106414, 300106399, 300106415, 300106416, 300106475, 300106476, 300106483, 300106486, 300106494, 300106534, 300106537, 300106538, 300106544, 300106545, 300106547, 300106548, 300106552, 300106648, 300106658, 300106675, 300106677, 300106678, 300106684, 300106754, 300106772, 300106775, 300106807, 300106809, 300106810, 300106812, 300106839, 300106842, 300106849, 300106855, 300106868, 300106891, 300106892, 300106899, 300106909, 300106926, 300106951, 300107003, 300106398, 300106481, 300106542, 300106546 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0031-2022%22
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