{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "221498", "product_res_number": "Z-3012-2026", "event_date_initiated": "2026-07-20", "event_date_posted": "2026-08-25", "recall_status": "Open, Classified", "res_event_number": "99404", "product_code": "DPS", "k_numbers": [ "K103640" ], "product_description": "Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062\nSoftware Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.", "code_info": "Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark IQecg Digital ECG. The Midmark IQecg Digital ECG system information is provided below. The total quantities manufactured and distributed noted below are the combined IQecgs Digital ECG and Midmark Digital ECG systems.\n\nSerial Numbers: 480000 4820704\n\nUDI-DI: 00841709100581, 00841709100321, 00841709100895, 00841709100901", "firm_fei_number": "1523530", "recalling_firm": "Midmark Corporation", "address_1": "60 Vista Dr", "city": "Versailles", "state": "OH", "postal_code": "45380-9488", "additional_info_contact": "Midmark Service Operations\n844-8561230 Ext. 2", "reason_for_recall": "A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.", "root_cause_description": "Software design", "action": "n URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/17/26 was sent to customers.\n\nSafety Instructions\nUntil the corrected IQecg Plugin software has been installed, for electrocardiogram tracings that reflect a fast heart rate (tachycardia), Midmark recommends performing a manual clinical assessment of the patient's heart rate prior to initiating therapeutic intervention. This bedside verification should be used to confirm the accuracy of the displayed ECG heart rate before making clinical management decisions based on the device's displayed value. If this issue is encountered, follow the temporary workaround instructions provided in Appendix A. Midmark will contact your facility with additional information regarding verification of your software installation and implementation of this Field Corrective Action.\n\nProduct Correction\nMidmark has developed a corrected version of the IQecg Plugin software that addresses the issue described in this notification and is implementing a Field Corrective Action for affected software versions.\nNo immediate action is required to contact Midmark at this time.\nMidmark will contact your facility to verify the IQecg Plugin software version(s) installed on your workstations and coordinate the appropriate correction process. Depending on your facility's configuration and support requirements, the correction may be completed using Midmark-provided installation instructions or with assistance coordinated by Midmark Technical Support or an authorized service provider.\nContact Information\nPlease be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact the Technical Service Team at 1.844.856.1230, option 2, or email techsupport@midmark.com.", "product_quantity": "3624 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the country of Canada.", "openfda": { "k_number": [ "K832212", "K020708", "K001034", "K961401", "K882472", "K170995", "K212112", "K831878", "K823220", "K991786", "K092576", "K240229", "K852281", "K052049", "K860734", "K864009", "K873346", "K883402", "K872658", "K230834", "K897121", "K871993", "K061123", "K232161", "K896417", "K101867", "K002459", "K032200", "K861851", "K060766", "K760465", "K001896", "K160667", "K120770", "K955642", "K102378", "K822582", "K180242", "K082312", "K852770", "K914762", "K230812", "K050686", "K844470", "K090212", "K823281", "K193415", "K822768", "K120865", "K052303", "K043074", "K151135", "K890791", "K170568", "K882198", "K874326", "K052295", "K012263", "K152384", "K091397", "K862748", "K850021", "K760272", "K955113", "K020366", "K884116", "K900700", "K760265", "K130921", "K013615", "K860175", "K152427", "K103640", "K160746", "K810263", "K951128", "K103077", "K010505", "K221141", "K864704", "K884992", "K191692", "K210560", "K914725", "K024278", "K163607", "K920020", "K042814", "K930558", "K882254", "K915879", "K860646", "K832050", "K210140", "K232974", "K180234", "K141582", "K142105", "K953415", "K960321", "K101403", "K830791", "K790739", "K082946", "K840571", "K902368", "K043380", "K150564", "K942629", "K082709", "K960449", "K800593", "K890481", "K972199", "K861359", "K813021", "K883468", "K131819", "K012264", "K760854", "K823488", "K860212", "K002074", "K172778", "K935394", "K110328", "K051534", "K801677", "K250569", "K864978", "K091358", "K760677", "K090936", "K111601", "K090367", "K070614", "K832130", "K823529", "K243305", "K243252", "K832013", "K093872", "K862381", "K884662", "K803309", "K972310", "K971038", "K832227", "K903671", "K171517", "K014262", "K790300", "K770832", "K102767", "K103765", "K933065", "K173830", "K862951", "K912183", "K811949", "K833593", "K950779", "K100813", "K880357", "K131262", "K821758", "K083715", "K974746", "K863535", "K220362", "K790939", "K964784", "K050858", "K110266", "K900598", "K954066", "K072353", "K131573", "K860636", "K131900", "K833470", "K881328", "K883454", "K112959", "K854234", "K972603", "K914206", "K981807", "K863116", "K221260", "K152135", "K791540", "K904758", "K864504", "K010822", "K082173", "K101876", "K152043", "K760150", "K884956", "K000645", "K904606", "K171360", "K183369", "K922927", "K102854", "K981697", "K160876", "K922291", "K072449", "K201456", "K811341", "K831429", "K861067", "K191738", "K921930", "K081437", "K770037", "K770760", "K780138", "K896064", "K852829", "K122073", "K093339", "K863100", "K961247", "K946205", "K042827", "K896190", "K811950", "K070539", "K152944", "K993414", "K950004", "K864700", "K031182", "K102206", "K170154", "K863652", "K863030", "K223013", "K872548", "K060167", "K093869", "K881055", "K961798", "K844744", "K131503", "K810104", "K813022", "K833584", "K840440", "K860790", "K071168", "K945626", "K851044", "K252361", "K013367", "K791364", "K121825", "K820067", "K832184", "K923221", "K042177", "K791201", "K050674", "K844101", "K892835", "K972991", "K955045", "K930134", "K881939", "K760271", "K934439", "K851322", "K203786", "K823584", "K821090", "K964408", "K143436", "K133985", "K770366", "K893660", "K223670", "K101115", "K832888", "K002822", "K913374", "K121009", "K173952", "K120188", "K033488", "K031422", "K011436", "K832883", "K013565", "K852322", "K813279", "K002473", "K882197", "K863914", "K851662", "K842944", "K802718", "K800566", "K802190", "K760542", "K901947", "K972996", "K841611", "K901817", "K131572", "K973437", "K132758", "K092010", "K143432", "K123217", "K131858", "K855096", "K050620", "K800005", "K173226", "K802368", "K130409", "K113485", "K903524", "K142551", "K011177", "K981951", "K220535", "K122632", "K851643", "K864580", "K113144", "K112622", "K760612", "K232445", "K012414", "K062068", "K062894", "K820011", "K780166", "K771380", "K933404", "K103427", "K152863", "K870380", "K760268", "K933156", "K832014", "K053083", "K896772", "K170182", "K232823", "K072217", "K864614", "K760926", "K222902", "K901032", "K111805", "K761023", "K901948", "K840569", "K003392", "K843934", "K910017", "K232512", "K760266", "K924544", "K093172", "K232035", "K810154", "K792072", "K923406", "K070136", "K233266", "K897029", "K850702", "K062469", "K901771", "K080933", "K012686", "K231150", "K024283", "K914974", "K790114", "K903722", "K101569", "K830666", "K082013", "K974351", "K861992", "K080999", "K760463", "K021230", "K182790", "K781679", "K062282", "K873584", "K791151", "K941811", "K171942", "K080036", "K850323", "K791420", "K130207", "K761198", "K182093", "K080884", "K091513", "K062677", "K221321", "K252474", "K051126", "K162665", "K862544", "K885177", "K875057", "K183425", "K052511", "K142288", "K800004", "K974220", "K833951", "K790233", "K100127", "K073625", "K811016", "K972746", "K963198", "K861281", "K950018", "K865031", "K072060", "K172068", "K112135", "K001492", "K182571", "K841148", "K860249", "K200036", "K093211", "K790794", "K200884", "K884800", "K082380", "K002197", "K032145", "K113234", "K800659", "K810357", "K052898", "K851633", "K830566", "K252463", "K081473", "K212278", "K844392", "K884896", "K832015", "K022149", "K031557", "K800492", "K111159", "K132068", "K050074", "K955416", "K880595", "K111438", "K790869", "K183322", "K854840", "K141946", "K022618", "K231160", "K991831", "K122712", "K970787", "K871239", "K890875", "K874641", "K781054", "K840869", "K241217", "K832421", "K051163", "K852282", "K142969", "K140020", "K241556", "K013564", "K952173", "K181998", "K110065", "K123816", "K792229", "K950989", "K973426", "K090483", "K993875", "K021171", "K810696", "K870880", "K915760", "K802952", "K864465", "K040313", "K171943", "K232816", "K760510", "K101016", "K955546", "K810988", "K864843", "K840020", "K790691", "K833458", "K900272", "K133622", "K092663", "K122356", "K963578", "K820014", "K884504", "K012540", "K862553", "K921331", "K850454", "K860973", "K090249", "K112431", "K013717", "K870926", "K030535", "K922703", "K160092", "K963400", "K883903", "K881475", "K811121", "K904355", "K251670", "K170954", "K850322", "K010955", "K896386", "K212163", "K113306", "K810176", "K894956", "K920364", "K955891", "K780307", "K943709", "K082967", "K010758", "K022152", "K980362", "K974079", "K160840", "K082124", "K903774", "K142693", "K861850", "K761014", "K791421", "K103791", "K841254", "K102830", "K161302", "K853979", "K852181", "K791795", "K802113", "K030104", "K821888" ], "registration_number": [ "3008483389", "3030154814", "3014541700", "3021559257", "3018587883", "3004415095", "3013298431", "8030245", "8030978", "1054713", "3013250653", "3013757696", "3010536822", "3003294644", "3013679558", "3008457078", "3043479346", "3007734888", "3003681187", "3003832357", "3013689228", "9611031", "3013896610", "3010838917", "3003647588", "9610105", "1219324", "3008716327", "3005521864", "3009715978", "3013188547", "1218950", "3031158", "9611295", "1651104", "3010419931", "3007413079", "2080783", "3011721071", "3021422553", "3008642652", "3014522540", "3036039911", "3004145393", "2000004234", "3042928308", "3010381606", "3011200896", "3018783526", "3016852448", "3013596024", "3001570235", "3033558564", "3007836437", "3033959233", "3023146633", "8030229", "3009443693", "3003857828", "3000130829", "3013557562", "3030125003", "3041276591", "3012421607", "3012516456", "3012250536", "3016701404", "2182208", "3014579161", "3023272766", "3010089768", "3043668257", "3011235999", "3008921101", "3015134086", "3008881835", "3012494290", "3007048291", "1314417", "3009607734", "3032109181", "3043226252", "1066427", "3007029079", "3012302888", "3007305624", "3023412068", "1450057", "3005488716", "9611252", "1319390", "3011359729", "3011651230", "3030447506", "3010342616", "3003263092", "3003591740", "3009183442", "3005569927", "3033536319", "1930027", "8030673", "3003622639", "3020981894", "3004582233", "3030733800", "3011353843", "3012404027", "1220477", "3034603279", "3035371769", "3012027770", "3001373226", "3038259592", "1316463", "3029871637", "1000122786", "3007384703", "3007134734", "3004035727", "3010082909", "3014848734", "3010698831", "3008717264", "3009499478", "3003971136", "3016674095", "2084041", "3010390468", "3010157426", "9617277", "3007770164", "3007184699", "9680510", "3003174284", "3031570367", "9611045", "3004906872", "9710602", "3000126629", "3004186703", "3045323923", "3012528160", "9615102", "3005783425", "3009735945", "3005877899", "1220908", "3016618143", "3030446844", "3006087789", "1126271", "3021131596", "3009077524", "3030639099", "3013501110", "2433214", "3009831876", "1523530", "3008164770", "9610816", "3013500228", "3032536454", "3008729547", "3006371704", "3010097171", "3019388613", "3016931915", "3014449259", "3006979678", "3008293988", "3015142815", "3031786139", "3030597723", "3008820594", "3012359877", "1066270", "3008505660", "3001149827", "3011861727", "3018094310", "3045498928" ], "fei_number": [ "3008483389", "3030154814", "3014541700", "3021559257", "1000271197", "3018587883", "3004415095", "3013298431", "3002807019", "3013250653", "3013757696", "3010536822", "3003294644", "3013679558", "3008457078", "3043479346", "3007734888", "3003681187", "3003832357", "3013689228", "3013896610", "3004213967", "3010838917", "3003647588", "1219324", "3008716327", "3005521864", "3009715978", "3013188547", "1218950", "3010419931", "3007413079", "2080783", "3011721071", "3021422553", "3008642652", "3014522540", "3036039911", "3004145393", "2000004234", "3042928308", "3010381606", "3011200896", "3018783526", "3016852448", "3013596024", "3007513035", "3001570235", "3033558564", "3007836437", "3003513129", "3033959233", "3023146633", "3009443693", "3003857828", "3000130829", "3002807167", "3013557562", "3030125003", "3041276591", "3000957797", "3012421607", "3012516456", "3012250536", "3016701404", "2182208", "3014579161", "3023272766", "3002807674", "3010089768", "3043668257", "3003190524", "3011235999", "3008921101", "3015134086", "3008881835", "3012494290", "3007048291", "1314417", "3009607734", "3032109181", "3043226252", "3007029079", "3012302888", "1000263641", "3007305624", "3023412068", "1450057", "3005488716", "1319390", "3011359729", "3011651230", "3000215024", "3030447506", "3010342616", "3003263092", "3003591740", "3009183442", "3005569927", "3033536319", "1930027", "3003622639", "3020981894", "3004582233", "3030733800", "3011353843", "3012404027", "1220477", "3034603279", "3035371769", "3012027770", "3001373226", "3038259592", "3002808182", "1316463", "3029871637", "1000122786", "3002807720", "3007384703", "3007134734", "3004035727", "3010082909", "3014848734", "3010698831", "3008717264", "3009499478", "3003971136", "3016674095", "2084041", "3010390468", "3010157426", "3003708031", "1000114111", "3007184699", "3007770164", "3003174284", "3031570367", "3004906872", "3000126629", "3004186703", "3002807992", "3045323923", "3012528160", "3005783425", "3009735945", "3002807739", "3005877899", "1220908", "3016618143", "3030446844", "3006087789", "3021131596", "3009077524", "3030639099", "3013501110", "2433214", "3009831876", "1523530", "3008164770", "3013500228", "3032536454", "3008729547", "3004072282", "3006371704", "3010097171", "3019388613", "3016931915", "3014449259", "3002806783", "3006979678", "3008293988", "3015142815", "3031786139", "3002737156", "3030597723", "3008820594", "3012359877", "3008505660", "3001149827", "3011861727", "3018094310", "3045498928" ], "device_name": "Electrocardiograph", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2340", "device_class": "2" } } ] }