{ "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": "2026-10-29", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "132362", "product_res_number": "Z-1068-2015", "event_date_initiated": "2015-01-02", "event_date_posted": "2015-02-09", "recall_status": "Terminated", "event_date_terminated": "2017-03-22", "res_event_number": "70157", "product_code": "GWF", "k_numbers": [ "K040358" ], "product_description": "EPWorks software used in the Xltek Protektor Stimulator\n\nProduct Usage:\nIntraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.", "code_info": "EPWorks Software Versions prior to 6.0", "firm_fei_number": "3002809369", "recalling_firm": "Natus Medical Incorporated", "address_1": "2568 Bristol Circle", "city": "Oakville Canada", "state": "Ontario", "reason_for_recall": "Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege.", "root_cause_description": "Software design", "action": "Natus Medical Inc. DBA Excel-Tech Ltd (Xltek) issued medical device notification letters dated December 22, 2014 to their customers vial email and via courier service on January 2, 2015. Within the notice, customers are instructed are on to removal the previous installation and also on how to install the new program upgrade. Natus Medical Inc. has requested that the Previous Version Removed from Use Confirmation form be completed by each customer and returned. Customers who require assistance can contact Natus Technical service by calling 800-387-7516 or via email Oakville_Technical_Service@xltek.com or ots@natus.com.", "product_quantity": "928 units", "distribution_pattern": "US Nationwide Distribution", "openfda": { "k_number": [ "K083371", "K091457", "K243982", "K170677", "K931923", "K123843", "K080499", "K083124", "K883340", "K031930", "K130346", "K192823", "K822396", "K230415", "K971740", "K871964", "K120979", "K960170", "K871338", "K830771", "K042350", "K233292", "K850109", "K071969", "K243495", "K955257", "K002773", "K810560", "K062765", "K992313", "K061639", "K843253", "K010090", "K112052", "K962457", "K952294", "K253301", "K020400", "K091940", "K905059", "K894608", "K781704", "K932994", "K992911", "K001101", "K851300", "K931428", "K981405", "K130403", "K860240", "K991899", "K111647", "K944547", "K880088", "K965065", "K780539", "K213849", "K860903", "K894560", "K923315", "K962458", "K234092", "K915652", "K926516", "K972959", "K980866", "K884870", "K810482", "K811848", "K900482", "K093304", "K094054", "K071821", "K903731", "K820414", "K890274", "K252842", "K822744", "K263010", "K924127", "K132616", "K142624", "K843712", "K112881", "K032741", "K000963", "K896567", "K950208", "K971819", "K843815", "K040358", "K072343", "K842543", "K912775", "K870567", "K242345", "K010092", "K030526", "K844992", "K051384", "K912685", "K923303", "K051864", "K002969", "K902607", "K924723", "K962455", "K820908", "K051357", "K843464", "K050798", "K831896", "K872106", "K855232", "K060847", "K110140", "K010087", "K182542", "K061645", "K234080", "K061113", "K162873", "K963662", "K885246", "K200759", "K120397", "K150220", "K190703", "K212166", "K863175", "K860968", "K162199", "K051178", "K861900", "K862690", "K844707", "K090298", "K822214", "K160280", "K082614", "K881915" ], "registration_number": [ "3001239363", "1650946", "2183456", "3003631667", "3043543260", "3003120897", "3004753785", "2080783", "9612330", "1056553", "1030489", "2023374", "8043933", "3013501110", "3010047454", "3012263546", "3023852420", "3006783837", "3007147067", "9612501", "3007770159", "3012182497", "1835251", "9612389", "3014251656", "3010123206", "1052723", "3005706667", "1221763", "3017636737", "2024311", "9613619", "9615126", "2032098", "3006418479", "1045254", "3005581270", "3018708317", "3006639944", "3030412764", "3009959868", "1317188", "1319639", "9611896", "3018094310", "3001687738", "3017448360", "2184161", "3024996452", "1119189", "3003851073", "3011790297", "3010611950", "3010209365", "3020018", "3008773490", "1930870", "9611252", "2530126", "1048735", "3006128100", "1824199", "3005545216", "3003935342", "3009144915", "3009973505", "2183946", "3016852448", "8021774", "3007713076", "3030154814", "3011766844", "2031966", "2031093", "2027467", "3009050824", "3010041499", "1526534", "3016438694", "3012352782", "1526711", "3019878714", "8030229", "3009973336", "3007962724", "2133772", "3007014520", "1047843" ], "fei_number": [ "3001239363", "2183456", "3003631667", "3043543260", "3003120897", "3004753785", "2080783", "3000209794", "2023374", "1000113738", "3013501110", "3010047454", "3002807720", "3012263546", "3023852420", "1000139867", "1000138054", "3007147067", "3007770159", "3012182497", "3003255845", "3014251656", "3010123206", "3005706667", "3002809369", "1221763", "3017636737", "2024311", "3006418479", "1045254", "3000205591", "3005581270", "3002980729", "3018708317", "3006639944", "3030412764", "3009959868", "3003058448", "1317188", "3018094310", "3001687738", "3002807739", "3017448360", "3003495548", "3024996452", "1119189", "3002808356", "1000132370", "3002716534", "3009322142", "3008647423", "3003851073", "3002619595", "3011790297", "1000477302", "3010611950", "3010209365", "3020018", "3004674371", "3008773490", "1930870", "1000116116", "1048735", "3006128100", "1824199", "3005545216", "3003935342", "3009144915", "3009973505", "3016852448", "1000221291", "3007713076", "3002957361", "3030154814", "3011766844", "2027467", "3009050824", "1526534", "3016438694", "3012352782", "1526711", "3019878714", "3009973336", "3007962724", "3007014520", "3001610756", "1047843", "3001236549" ], "device_name": "Stimulator, Electrical, Evoked Response", "medical_specialty_description": "Neurology", "regulation_number": "882.1870", "device_class": "2" } } ] }