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

Recall number

Z-0031-2022

Recalling firm

NOX MEDICAL

Product

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

Status

Terminated

Initiated

2021-09-07

Posted

not on file

Terminated

2023-05-01

Reason

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

Root cause

Finished device change control

Action

Written notification letter titled, "URGENT: Medical Device Recall" was sent to all consignees on 09/07/2021. The letter instructs the consignee to follow the following instructions: "Further distribution or use of the affected devices should cease immediately. Devices should be quarantined pending device firmware update, per the instructions below. Due to the potential of inaccurate position-related reporting of TST, TRT, AHI and REI; studies performed with the affected T3s devices should be reanalyzed to determine if this has clinical impact on the patient diagnoses. A Nox Medical technical representative will contact you within 5 business days to schedule a remote session (via videoconference or other means) to upgrade the device firmware. Nox Medical requests that you formally acknowledge receipt of this notice and return the attached Customer / Distributor - Acknowledgement and Receipt Form (Attachment 1). This recall notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. If any affected devices which were in your possession (indicated in Attachment 2: Product Distribution and Information Table) have been transferred, please indicate this and provide as much detail as possible in the Acknowledgement and Receipt Form (Attachment 1)."

Quantity

128 units

Distribution

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

Lot, serial or model codes

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, 300106782, 300106910, 300106400, 300106535, 300106536, 300106808, 300106950, 300106469, 300106470, 300106869, 300106854, 300106478, 300106805, 300106811, 300106840, 300106850, 300106856, 300106859, 300106887, 300106893, 300106895, 300106896, 300106898, 300107005, 300106776, 300106781, 300106789, 300106788, 300106833, 300106549, 300106543, 300106557, 300106540, 300106533, 300106556, 300106555, 300106901, 300106786, 300106553, 300106784, 300106541, 300106777, 300106774

510(k) numbers

["K082113"]

PMA numbers

not on file

Product code

MNR

Firm FEI

3007389703

Firm city

Reykjavik

Firm state

not on file

Firm country

Iceland

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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