{ "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": "2026-10-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "222448", "product_res_number": "Z-0141-2027", "event_date_initiated": "2026-08-18", "event_date_posted": "2026-10-09", "recall_status": "Open, Classified", "res_event_number": "99774", "product_code": "GWF", "k_numbers": [ "K162199" ], "product_description": "Brand Name: IOMAX\r\nProduct Name: IOMAX Cortical Module\r\nModel/Catalog Number: 190296-200\r\nUDI-DI code: 00840067100653\r\nProduct Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low current electrical stimulator, a TCS stimulator, a visual stimulator and an auditory stimulator. The low current stimulator has one (1) constant current output pair with a current range of 0.01-20 mA. The TCS stimulator has nine (9) independent constant current/constant voltage outputs, with current range of 50-1500 mA and voltage range of 50-1000 V.\r\nComponent: Is the cortical component of the IOMAX system", "code_info": "Model/Catalog Number: 190296-200\nUDI-DI code: 00840067100653\nLot Code: These devices are identified by the serial numbers listed below: \n19029607AA0326007\n19029607AA0226013\n19029607AA0426028\n19029607AA0226010\n19029607AA0226007\n19029607AA0326026\n19029607AA0226015\n19029607AA0326020\n19029607AA0326018\n19029607AA0326021\n19029607AA0326022\n19029607AA0226009\n19029607AA0526022\n19029607AA0326017\n19029607AA0326027\n19029607AA0326016\n19029607AA0226016\n19029607AA0326028\n19029607AA0326024\n19029607AA0326025\n19029607AA0326023\n19029607AA0326031\n19029607AA0326006", "firm_fei_number": "3020018", "recalling_firm": "Cadwell Industries Inc", "address_1": "909 N Kellogg St", "city": "Kennewick", "state": "WA", "postal_code": "99336-7669", "additional_info_contact": "509-735-6481", "reason_for_recall": "Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to reach the patient.", "root_cause_description": "Under Investigation by firm", "action": "On 08/18/2026, an \"URGENT: MEDICAL DEVICE RECALL\" Letter was emailed informing customers that, a manufacturing defect was identified in a limited number of IOMAX Cortical Modules. Following a recent change in printed circuit board assembly (PCBA) vendor, the defect was discovered during routine production processes on a limited number of PCBA s that were used in IOMAX Cortical Modules. The identified risk is specific to the Cortical Module and Cascade Surgical Studio (CSS). However, because Cortical Modules can be used with Zenith, Arc, and CSS, a module currently in use with Zenith or Arc could later be connected to CSS. Cadwell is therefore recalling all potentially affected Cortical Modules regardless of current host system. If the defective PCBA is present, it could potential cause unintentionally deliver electrical stimulation to the patient, or allow a small amount of unintended electrical current to reach the patient.\n\nCustomers are instructed to return all identified devices to Cadwell Industries, Inc.\n\nCadwell Industries, Inc. is voluntarily recalling and replacing or repairing all affected devices from the field.", "product_quantity": "23", "distribution_pattern": "Worldwide - US Nationwide distribution in the state of TN and the countries of Spain, Vietnam, Malaysia, Saudi Arabia, Thailand, Israel, Mexico, Turkey, Oman, Colombia, Brazil, Belgium, Italy, South Africa, and Switzerland.", "openfda": { "k_number": [ "K883340", "K992911", "K912685", "K863175", "K190703", "K884870", "K010087", "K903731", "K860903", "K112052", "K843253", "K162873", "K950208", "K991899", "K071821", "K971740", "K811848", "K870567", "K900482", "K810482", "K992313", "K001101", "K082614", "K212166", "K860240", "K822744", "K831896", "K912775", "K010090", "K243495", "K213849", "K931428", "K844992", "K090298", "K130403", "K850109", "K010092", "K182542", "K093304", "K243982", "K030526", "K040358", "K932994", "K051178", "K851300", "K830771", "K810560", "K962458", "K091940", "K233292", "K885246", "K905059", "K130346", "K780539", "K094054", "K112881", "K872106", "K060847", "K252842", "K080499", "K123843", "K960170", "K880088", "K915652", "K162199", "K192823", "K234092", "K952294", "K926516", "K871964", "K132616", "K050798", "K843712", "K820908", "K032741", "K120979", "K061645", "K150220", "K083371", "K061639", "K230415", "K944547", "K844707", "K170677", "K822396", "K862690", "K111647", "K962455", "K062765", "K955257", "K822214", "K965065", "K923315", "K071969", "K000963", "K843815", "K002969", "K871338", "K142624", "K924127", "K924723", "K253301", "K972959", "K890274", "K855232", "K051384", "K263010", "K861900", "K042350", "K234080", "K981405", "K120397", "K963662", "K860968", "K072343", "K781704", "K894608", "K020400", "K980866", "K031930", "K160280", "K902607", "K842543", "K061113", "K200759", "K091457", "K923303", "K971819", "K820414", "K894560", "K002773", "K931923", "K051864", "K110140", "K083124", "K962457", "K881915", "K242345", "K896567", "K051357", "K843464" ], "registration_number": [ "3010123206", "1835251", "8043933", "2183946", "1824199", "3016438694", "3004753785", "1317188", "3011790297", "9611896", "3010041499", "3001239363", "8030229", "3006418479", "3012352782", "3017636737", "3013501110", "1045254", "3016852448", "1030489", "3007014520", "3000279201", "2133772", "3010611950", "3009959868", "3011766844", "1930870", "2183456", "3009973505", "3007713076", "1056553", "1048735", "3005545216", "3010047454", "3014251656", "3020018", "3024996452", "3009050824", "9613619", "1047843", "9612501", "3006128100", "2530126", "3008773490", "3006639944", "3009144915", "3007962724", "3001687738", "8021774", "3012263546", "9612389", "3030412764", "3003120897", "2031966", "2027467", "9611252", "1319639", "3009973336", "3043543260", "2031093", "3003935342", "2184161", "1526534", "3030154814", "3017448360", "3003851073", "2023374", "3010209365", "3007147067", "3012182497", "1526711", "1221763", "2032098", "3023852420", "1650946", "9612330", "1119189", "2024311", "3005581270", "3003631667", "3007770159", "3005706667", "9615126", "1052723", "3018094310", "3018708317", "3006783837", "3019878714", "2080783" ], "fei_number": [ "3010123206", "1824199", "3002808356", "3016438694", "3004753785", "1317188", "3011790297", "3001239363", "3006418479", "3012352782", "1000113738", "3017636737", "3013501110", "1045254", "3016852448", "3002807739", "3007014520", "3000279201", "3010611950", "3009959868", "3002980729", "3011766844", "3002809369", "1930870", "2183456", "3009973505", "3007713076", "1048735", "3005545216", "1000477302", "1000139867", "3010047454", "3014251656", "3020018", "3024996452", "3009050824", "1047843", "1000132370", "3006128100", "3002957361", "3008647423", "1000221291", "3008773490", "3006639944", "3002716534", "3009144915", "3007962724", "3001687738", "3003058448", "3012263546", "1000116116", "3000205591", "3030412764", "3003120897", "3002807720", "2027467", "3003495548", "3009973336", "3001610756", "3043543260", "3003935342", "1000138054", "1526534", "3000209794", "3030154814", "3017448360", "3004674371", "3003851073", "2023374", "3010209365", "3007147067", "3012182497", "1526711", "3009322142", "1221763", "3023852420", "3002619595", "1119189", "2024311", "3005581270", "3003631667", "3007770159", "3005706667", "3003255845", "3001236549", "3018094310", "3018708317", "3019878714", "2080783" ], "device_name": "Stimulator, Electrical, Evoked Response", "medical_specialty_description": "Neurology", "regulation_number": "882.1870", "device_class": "2" } } ] }