{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "189249", "product_res_number": "Z-0031-2022", "event_date_initiated": "2021-09-07", "event_date_created": "2021-10-05", "recall_status": "Terminated", "event_date_terminated": "2023-05-01", "res_event_number": "88673", "product_code": "MNR", "k_numbers": [ "K082113" ], "product_description": "Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.", "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 \n, 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", "firm_fei_number": "3007389703", "recalling_firm": "NOX MEDICAL", "address_1": "Keldnaholt", "city": "Reykjavik", "country": "Iceland", "additional_info_contact": "844-4753376", "reason_for_recall": "Error in the device firmware results in the inaccurate detection of device position.", "root_cause_description": "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:\n\"Further distribution or use of the affected devices should cease immediately. Devices should be quarantined pending device firmware update, per the instructions below.\nDue 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.\nA 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.\nNox Medical requests that you formally acknowledge receipt of this notice and return the attached Customer / Distributor - Acknowledgement and Receipt Form (Attachment 1).\n\nThis 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.\n\nIf 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).\"", "product_quantity": "128 units", "distribution_pattern": "US Nationwide distribution in the states of OH, IL, GA, IA, CA, PA, NM, MI, SD.", "openfda": { "k_number": [ "K081037", "K021176", "K161579", "K081861", "K102567", "K040576", "K081982", "K122516", "K080321", "K180001", "K244027", "K112102", "K060708", "K090484", "K151433", "K022506", "K944524", "K082853", "K081176", "K021138", "K110064", "K962103", "K151874", "K112514", "K002159", "K041904", "K990565", "K124062", "K042916", "K242290", "K183625", "K002135", "K203839", "K950273", "K191095", "K233501", "K010156", "K971184", "K151361", "K984169", "K971803", "K220095", "K041724", "K240100", "K061764", "K200695", "K254042", "K080983", "K163665", "K200654", "K024322", "K112822", "K072014", "K203343", "K061996", "K221816", "K973920", "K260050", "K043132", "K222331", "K240285", "K944611", "K231355", 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