Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Check against the official notice below — it lists the full affected range.
Nox Medical is recalling 128 units of the Nox T3s Recorder, a device used to record physiological signals during sleep. The devices are affected by a firmware error that causes inaccurate detection of device position. The recalled units were distributed nationwide in Ohio, Illinois, Georgia, Iowa, California, Pennsylvania, New Mexico, Michigan, and South Dakota, and can be identified by Catalog Number 561111 and specific serial numbers listed in the recall notice.
The recall notice does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Error in the device firmware results in the inaccurate detection of device position.
Reason for recall: Error in the device firmware results in the inaccurate detection of device position. Distribution: US Nationwide distribution in the states of OH, IL, GA, IA, CA, PA, NM, MI, SD. Quantity: 128 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.