Z-0031-2022Class II

Nox T3s Recorder -

Name: Z-0031-2022 Nox T3s Recorder -
Creator: Nox Medical
Published: 2021-09-07
License: https://open.fda.gov/license/

Nox Medical / initiated 2021-09-07 / Terminated / root cause: software

FDA source

NOX MEDICAL began a recall of Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep on 2021-09-07. FDA classified it as Class II and gives the reason as "Error in the device firmware results in the inaccurate detection of device position". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0031-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-07
Posted: 2021-10-05
Terminated: 2023-05-01
Recalling firm: Nox Medical
Product: Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Product code: MNR Ventilatory Effort Recorder
Reason for recall: Error in the device firmware results in the inaccurate detection of device position.
Root cause tag: software
FDA 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 in commerce: 128 units
Distribution: US Nationwide distribution in the states of OH, IL, GA, IA, CA, PA, NM, MI, SD.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0031-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0031-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-13	2021-10-05

Product code MNR

K082113Class IINox T3, Noxturnal (Pc Application)Nox Medical / cleared 2008-11-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)