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U.S. Department of Health and Human Services

Class 2 Device Recall Nox T3S Recorder

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  Class 2 Device Recall Nox T3S Recorder see related information
Date Initiated by Firm September 07, 2021
Create Date October 05, 2021
Recall Status1 Terminated 3 on May 01, 2023
Recall Number Z-0031-2022
Recall Event ID 88673
510(K)Number K082113  
Product Classification Ventilatory effort recorder - Product Code MNR
Product Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Code Information 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
Recalling Firm/
Manufacturer		 NOX MEDICAL
Keldnaholt
Reykjavik Iceland
For Additional Information Contact
844-4753376
Manufacturer Reason
for Recall		 Error in the device firmware results in the inaccurate detection of device position.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MNR and Original Applicant = NOX MEDICAL
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