{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "139574", "product_res_number": "Z-0117-2016", "event_date_initiated": "2015-09-11", "event_date_posted": "2015-10-13", "recall_status": "Terminated", "event_date_terminated": "2016-03-08", "res_event_number": "71991", "product_code": "GWQ", "k_numbers": [ "K964280" ], "product_description": "NicoletOne Software v5.94, Catalog/Part Number: 482-649600.\r\nThe NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and extracerebral activity for Clinical EEG, Electrocorticography (EcOG), Long Term Monitoring (LTM), Intensive Care Unit (ICU) monitoring and Polysomnography (PSG) Sleep studies. While the Nicolet Neurodiagnostic systems are capable of displaying signals, such as Sp02 and EKG, the system is NOT intended for monitoring such signals for the preservation of life, The Nicolet Neurodiagnostic systems are intended to acquire, analyze, and display data", "code_info": "Serial numbers include TS150456M, TR150171M, TR150172M, 1TR150173M, TR150174M, TS150451M, TS150452M, TR150170M, UH150119M, TR150169M, UR150226M, UR150227M, UR150228M, UR150229M, TS150455M, TS150457M, TS150458M, TS150454M, TS150453M, UC150184M, PN151700M, SJ150272M, TT150134M, PN151699M, UR150230M, UR150231M, and SJ150271M.", "firm_fei_number": "3010611950", "recalling_firm": "Natus Neurology Inc", "address_1": "3150 Pleasant View Rd", "city": "Middleton", "state": "WI", "postal_code": "53562-4800", "additional_info_contact": "Toni Gorman\n608-829-8600", "reason_for_recall": "When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG screen, the impedance check signal remains active in waveform, obscuring the EEG signals.", "root_cause_description": "Software change control", "action": "Natus Neurology sent an Ugent Medical Device Corrrection Notification letter dated September 9, 2015 to all affected consignees. The letter described the problem and the product involved in the recall. Consignees were informed consignees that a Field Service Technician will contact them to install the new software. Once the software is installed they will ask the Recipient or Field service Technician to complete and return the Verification Form.\r\nFor questions regarding this recall call 608-829-8600.", "product_quantity": "101 (88 US, 13 OUS)", "distribution_pattern": "Worldwide distribution. US nationwide, INDIA, ROMANIA, DENMARK, JAPAN, AUSTRALIA, RUSSIA, BANGLADESH, SRI LANKA, BRUNEI, and UNITED ARAB EMIRATES.", "openfda": { "k_number": [ "K150498", "K131383", "K894276", "K081151", "K944678", "K040554", "K112107", "K051825", "K841683", "K820605", "K895125", "K022785", "K010150", "K802296", "K010086", "K171781", "K983533", "K914571", "K822700", "K932842", "K010669", "K820066", "K014147", "K081741", "K910945", "K932407", "K192753", "K962447", "K941551", "K854663", "K901549", "K896942", "K043309", "K010997", "K973883", "K101386", "K911229", "K053386", "K946094", "K260455", "K042150", "K221963", "K261604", "K905435", "K904763", "K180269", "K823116", "K071109", "K112353", "K850418", "K781005", "K001103", "K103129", "K033978", "K000898", "K120888", "K000919", "K890881", "K122196", "K970703", "K061908", "K802292", "K991033", "K023771", "K162595", "K014146", "K870815", "K863193", "K933951", "K923860", "K002570", "K083577", "K233403", "K113117", "K143233", "K823140", "K896666", 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