{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "193616", "product_res_number": "Z-1223-2022", "event_date_initiated": "2022-05-03", "event_date_posted": "2022-06-02", "recall_status": "Open, Classified", "res_event_number": "90163", "product_code": "GWF", "k_numbers": [ "K200759" ], "product_description": "NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2", "code_info": "Model Number: NIM4CM01; UDI/DI: 00763000395896, lot numbers: C2026207, C2026233, C2026320, C2026335, C2026354, C2026376, C2110046, C2110089, C2110131, C2110196, C2110198, C2110208, C2110217, C2110223 and 00763000002978, lot numbers: C1915048, C1915078, C1915099, C1915188, C2026207, C2026233, C2026320, C2026335, C2026354, C2026376, C2110046, C2110089, C2110131, C2110196, C2110198, C2110208, C2110217, C2110223.", "firm_fei_number": "1045254", "recalling_firm": "Medtronic Xomed, Inc.", "address_1": "6743 Southpoint Dr N", "city": "Jacksonville", "state": "FL", "postal_code": "32216-6218", "additional_info_contact": "Marie Gentile\n904-296-9600", "reason_for_recall": "Software anomaly was identified.", "root_cause_description": "Software Design Change", "action": "The firm issued a recall notification to consignees on 05/03/2022 via mail. The letter instructs the consignee to follow the IFU regarding the setup and \"Lead Off Detected\" error message, forward the notification to those who need to be aware within the organization and to any location which the devices have been distributed, and to complete the response form. \n\nAn additional correction notification was sent on about 09/13/2023 to notify consignees of the update availability (NIM Vital\" SW version v1.4.3) to fix this issue.", "product_quantity": "18 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.", "openfda": { "k_number": [ "K830771", "K162873", "K861900", "K850109", "K242345", "K923303", "K883340", "K111647", "K843253", "K860968", "K150220", "K862690", "K822744", "K234092", "K843815", "K810560", "K900482", "K950208", "K991899", "K082614", "K885246", "K123843", "K243495", "K860240", "K871338", "K872106", "K992313", "K050798", "K142624", "K844707", "K071969", "K110140", "K902607", "K851300", "K091940", "K083371", "K971740", "K170677", "K971819", "K944547", "K061645", "K810482", "K884870", "K061639", "K230415", "K162199", "K083124", "K060847", "K831896", "K160280", "K894608", "K860903", "K972959", "K020400", "K212166", "K912775", "K822396", "K002969", "K890274", "K915652", "K960170", "K992911", "K870567", "K071821", "K842543", "K843712", "K090298", "K061113", "K962455", "K881915", "K213849", "K132616", "K822214", "K001101", "K980866", "K843464", "K051384", "K923315", "K905059", "K234080", "K931923", "K010092", "K000963", "K880088", "K863175", "K120397", "K931428", "K233292", "K820414", "K820908", "K780539", "K031930", "K112881", "K871964", "K182542", "K192823", "K062765", "K112052", "K200759", "K924723", "K120979", "K896567", "K965065", "K040358", "K903731", "K091457", "K010087", "K243982", "K051178", "K032741", "K963662", "K010090", "K051864", "K094054", "K952294", "K002773", "K912685", "K811848", "K190703", "K130346", "K030526", "K962458", "K844992", "K955257", "K981405", "K080499", "K130403", "K781704", "K252842", "K051357", "K042350", "K253301", "K926516", "K093304", "K894560", "K932994", "K855232", "K924127", "K072343", "K962457" ], "registration_number": [ "9611896", "1052723", "2027467", "8043933", "1824199", "3010047454", "3007962724", "3006639944", "9613619", "3006418479", "2031966", "3007713076", "1930870", "3006783837", "9611252", "3001687738", "1045254", "3014251656", "9615126", "2530126", "3009973336", "3020018", "1526534", "3019878714", "2024311", "3009050824", "3024996452", "2183456", "3017636737", "1047843", "9612330", "9612389", "3018094310", "1221763", "3012263546", "3043543260", "3001239363", "3012352782", "3017448360", "3003851073", "2183946", "3010123206", "3009144915", "3009959868", "3023852420", "3000279201", "3012182497", "8030229", "3010041499", "3005545216", "3003935342", "3006128100", "3030412764", "2133772", "1030489", "3016438694", "1319639", "1526711", "3003120897", "2080783", "3005581270", "1119189", "2032098", "3008773490", "3016852448", "8021774", "3004753785", "2023374", "3007014520", "3030154814", "3018708317", "3011766844", "1650946", "9612501", "3007770159", "3010209365", "3010611950", "3011790297", "1056553", "2031093", "1835251", "3007147067", "3003631667", "2184161", "3005706667", "1048735", "3013501110", "1317188", "3009973505" ], "fei_number": [ "2027467", "1000138054", "1824199", "3010047454", "3007962724", "1000477302", "3006639944", "3006418479", "3007713076", "3000205591", "3002957361", "1930870", "3003058448", "3001687738", "1045254", "3014251656", "3009973336", "3020018", "1526534", "3019878714", "3009322142", "2024311", "3009050824", "3024996452", "2183456", "3017636737", "1047843", "3018094310", "1221763", "3012263546", "3001610756", "3043543260", "3001239363", "3012352782", "3002807739", "3017448360", "3002716534", "3002809369", "3003851073", "3010123206", "3001236549", "3002808356", "3002807720", "3009144915", "3000209794", "3009959868", "3023852420", "3000279201", "3012182497", "3003255845", "3005545216", "1000139867", "3003935342", "3006128100", "3030412764", "3016438694", "3004674371", "1526711", "1000113738", "3003120897", "2080783", "3005581270", "1119189", "3008773490", "3016852448", "3004753785", "2023374", "3007014520", "3030154814", "1000116116", "1000221291", "1000132370", "3018708317", "3011766844", "3002619595", "3007770159", "3010209365", "3010611950", "3011790297", "3007147067", "3003631667", "3003495548", "3005706667", "1048735", "3013501110", "1317188", "3008647423", "3009973505", "3002980729" ], "device_name": "Stimulator, Electrical, Evoked Response", "medical_specialty_description": "Neurology", "regulation_number": "882.1870", "device_class": "2" } } ] }