Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Summary
The FDA issued a Class II for Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiolog by NOX MEDICAL. Reason: Error in the device firmware results in the inaccurate detection of device position..
Details
Source
Device Recall
External ID
Z-0031-2022
Action Date
2021-10-13
Status
Terminated
Category
device
Product Description
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
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
Quantity Affected: 128 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-07
Company
Reykjavik
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 192 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (NOX MEDICAL) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NOX MEDICAL have FDA actions?
This is the only FDA action we have on record for NOX MEDICAL in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0031-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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