{ "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": 12 } }, "results": [ { "cfres_id": "48578", "product_res_number": "Z-0218-2007", "event_date_initiated": "2006-08-23", "event_date_posted": "2006-11-28", "recall_status": "Terminated", "event_date_terminated": "2008-05-23", "res_event_number": "36394", "product_code": "GWF", "k_numbers": [ "K991899" ], "product_description": "Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System)", "code_info": "Any serial numbers up to 02160", "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": "Serrah Namini\n949-580-1555 Ext. 4401", "reason_for_recall": "When the device is subject to physical shock, such as a drop to the floor, it may output a different value from the preset value. This may result in a superficial burn on the patient if the stimulation is done for a long time.", "root_cause_description": "Other", "action": "All customers will be called by phone, then faxed the Product Notification starting 09/01/2006 \n\nCustomers were instructed to indicate the serial numbers on each of your MS-210BK stimulators and fax the MS-210BK PRODUCT RECALLREPLACEMENT letter back to Nihon Kohden at: 949-580-15550 or email to customerservice@nkusa.com. Upon receipt of this letter, Nihon Kohden''s customer service department will send a replacement unit.", "product_quantity": "97 units in the U.S.", "distribution_pattern": "Nationwide.", "openfda": { "k_number": [ "K192823", "K090298", "K843464", "K923303", "K952294", "K150220", "K871964", "K962455", "K031930", "K924723", "K971740", "K962458", "K000963", "K010087", "K831896", "K182542", "K091457", "K061645", "K093304", "K051864", "K061113", "K051384", "K890274", "K243495", "K955257", "K843253", "K212166", "K213849", "K030526", "K931923", "K111647", "K234092", "K965065", "K810482", "K010092", "K883340", "K860903", "K123843", "K190703", "K950208", "K880088", "K080499", "K822214", "K960170", "K862690", "K912685", "K162873", "K842543", "K843712", "K233292", "K885246", "K900482", "K923315", "K924127", "K160280", "K881915", "K863175", "K120979", "K130346", "K234080", "K010090", "K071821", "K931428", "K083124", "K001101", "K050798", "K002773", "K811848", "K905059", "K844707", "K082614", "K992313", "K820414", "K850109", "K861900", "K871338", "K110140", "K094054", "K142624", "K242345", "K894608", "K002969", "K120397", "K072343", "K230415", "K112052", "K051178", "K894560", "K915652", "K944547", "K170677", "K981405", "K061639", "K992911", "K872106", "K851300", "K822744", "K980866", "K926516", "K932994", "K020400", "K112881", "K780539", "K855232", "K991899", "K162199", "K884870", "K971819", "K843815", "K860240", "K060847", "K962457", "K870567", "K062765", "K963662", "K253301", "K820908", "K972959", "K781704", "K903731", "K902607", "K896567", "K844992", "K252842", "K822396", "K091940", "K032741", "K860968", "K071969", "K200759", "K130403", "K132616", "K912775", "K083371", "K830771", "K042350", "K051357", "K040358", "K810560", "K243982" ], "device_name": "Stimulator, Electrical, Evoked Response", "medical_specialty_description": "Neurology", "regulation_number": "882.1870", "device_class": "2", "registration_number": [ "3003120897", "3018094310", "3008773490", "3010047454", "3003851073", "1048735", "3003631667", "3010611950", "3007713076", "3012182497", "8043933", "3017448360", "3011766844", "3043543260", "2031966", "1824199", "1056553", "3024996452", "2184161", "3001687738", "1221763", "2032098", "1835251", "3023852420", "8021774", "2024311", "8030229", "3012352782", "3030154814", "2031093", "3007962724", "9613619", "3006639944", "9615126", "3016852448", "3010041499", "3013501110", "2080783", "1930870", "3017636737", "2183456", "3005706667", "3016438694", "3000279201", "2023374", "3010123206", "1030489", "3030412764", "3009973336", "1526534", "2183946", "1119189", "3018708317", "3011790297", "9611252", "3009973505", "3009959868", "1047843", "3014251656", "9612330", "3007014520", "3006783837", "3001239363", "2027467", "3005545216", "3012263546", "3004753785", "9611896", "9612501", "1650946", "3019878714", "3010209365", "1052723", "2133772", "3003935342", "3007770159", "9612389", "3007147067", "3009050824", "2530126", "1319639", "3020018", "3003080184", "1045254", "3005581270", "1526711", "3006128100", "3006418479", "3009144915" ], "fei_number": [ "3003120897", "3002807720", "3018094310", "3008773490", "3002807739", "3010047454", "3003851073", "1048735", "1000139867", "3003631667", "3010611950", "3007713076", "3012182497", "3017448360", "3011766844", "3043543260", "3002980729", "3009144915", "1824199", "3024996452", "3001687738", "1221763", "3023852420", "1000138054", "2024311", "3012352782", "3030154814", "3009322142", "3002957361", "3007962724", "3006639944", "3016852448", "3000209794", "3013501110", "2080783", "1930870", "3017636737", "2183456", "3005706667", "3016438694", "3000279201", "2023374", "3010123206", "3030412764", "3004674371", "3002619595", "3002716534", "3008647423", "1000221291", "1000116116", "3009973336", "1526534", "3003495548", "3002808356", "1119189", "3018708317", "3011790297", "3000205591", "3002809369", "3009973505", "3009959868", "1047843", "3014251656", "3007014520", "3001239363", "3003058448", "1000113738", "2027467", "3005545216", "3012263546", "3004753785", "3019878714", "3010209365", "3001236549", "3003935342", "3007770159", "3007147067", "3009050824", "1000477302", "3020018", "3003080184", "1045254", "3005581270", "3001610756", "1526711", "1000132370", "3006128100", "3006418479", "3003255845" ] } } ] }