Nox T3s Recorder - Product Usage: intended for recall
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Why was Nox T3s Recorder - Product Usage: intended for recalled?
Error in the device firmware results in the inaccurate detection of device position.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
- Recalling firm
- NOX MEDICAL
- Quantity
- 128 units
- Distribution
- US Nationwide distribution in the states of OH, IL, GA, IA, CA, PA, NM, MI, SD.
- Recall date
- October 13, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)