{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "185038", "product_res_number": "Z-0865-2021", "event_date_initiated": "2020-12-21", "event_date_posted": "2021-01-14", "recall_status": "Open, Classified", "res_event_number": "87011", "product_code": "GWQ", "k_numbers": [ "K120888" ], "product_description": "PSG-1100 Sleep Diagnostic System.\n\nSample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan\n\nThe PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies.", "code_info": "Serial numbers 3. Serial numbers\t320, 470, 507, 534, 621, 757, 770, 795, 892, 1165-1183, 1186- 1205, 1214-1293, 1295-1297, 1304-1330, 1333-1342, 1358 -1384, 1387-1389, 1391-1413, 1421-1430, 1434-1505, 1507- 1516.", "firm_fei_number": "2080783", "recalling_firm": "Nihon Kohden America Inc", "address_1": "90 Icon", "city": "Foothill Ranch", "state": "CA", "postal_code": "92610-3000", "additional_info_contact": "Nihon Kohden America Technical Services Group\n800-325-0283", "reason_for_recall": "Medical device non-conformance to electrical safety standard (IEC 60601-1).", "root_cause_description": "Device Design", "action": "On 12/21/2020, the firm , Nihon Kohden, sent out an \"URGENT RECALL NOTIFICATION\" letter dated 12/21/2020 to all affected consumers . The letter described the product, problem and actions to be taken. The customers were instructed to do the following:\n1. Inform potential users in your organization of this notification.\n2. Complete the attached reply form and return it to the fax number (949) 580-1550 or email it to: JB110@NKUSA.com or JB110@nihonkohden.com.\n\nIf you have any questions, please call the Toll-free: 1-800-325-0283, Option 6 (Monday-Friday,8am-5pm PDT) or E-mail: JB110@NKUSA.com or\nJB110@nihonkohden.com.", "product_quantity": "189 Units", "distribution_pattern": "US Nationwide Distribution - CA, CO, CT, FL, ID, IL, IN, MA, MD, MI, MO, NC, NM, NY, SC, TX, TN, UT, VA, VT and WA.", "openfda": { "k_number": [ "K902752", "K925838", "K974495", "K791150", "K131383", "K921927", "K170441", "K040554", "K902550", "K854268", "K081741", "K904269", "K922548", "K260455", "K910945", "K112817", "K903004", "K113117", "K932842", "K231366", "K983533", "K180181", "K213900", "K890881", "K100683", "K220056", "K951507", "K093223", "K021599", "K911229", "K010086", "K192753", "K261604", "K001103", "K883557", "K043309", "K180290", "K961642", "K820603", "K923894", "K120888", "K223644", "K944678", "K033399", 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"K972202", "K212788", "K870263", "K162681", "K112353", "K894276", "K873535", "K143440", "K221959", "K181466", "K971331", "K973883", "K831324", "K122196", "K982479", "K171781", "K010697", "K010088", "K850418", "K964280", "K823140", "K010150", "K791234", "K221963", "K980214", "K923950", "K932407", "K851232", "K002570", "K171124", "K930080", "K042150", "K201819", "K933951", "K061908", "K230073", "K820604", "K231457", "K854663", "K921485", "K791233", "K011430", "K871500", "K820605", "K180269", "K954954", "K133355", "K863193", "K083577", "K910279", "K171384", "K014146", "K040360", "K014147" ], "device_name": "Full-Montage Standard Electroencephalograph", "medical_specialty_description": "Neurology", "regulation_number": "882.1400", "device_class": "2", "registration_number": [ "3011766844", "3003851073", "2184161", "1530224", "3004753785", "3009831876", "2023374", "3007701713", "9613619", "3007048291", "3006315274", "3001687738", "3016701404", "3013413442", "1045254", "3009649442", 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