{"recall":{"id":"fda-device-99404","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Midmark Corporation recalls 2 products","firm":"Midmark Corporation","date":"2026-07-20","reported":"2026-09-02","status":"Ongoing","classification":"Class II","products":[{"name":"Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.","code":"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. Serial Numbers: 480000 4820704 UDI-DI: 00841709100581, 00841709100321, 00841709100895, 00841709100901","quantity":"3624 units","number":"Z-3012-2026","classification":"Class II"},{"name":"Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.","code":"Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark Digital ECG. The Midmark 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. Serial Numbers: 7817519 7817645, L1130587 V2967564 UDI-DI: 00841709121319, 08056732652491","quantity":"3624 units","number":"Z-3013-2026","classification":"Class II"}],"reason":"A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide distribution - US Nationwide and the country of Canada.","nationwide":true,"states":[],"units":"3624 units; 3624 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99404","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"333114210d9b7e41","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99404","record":[{"status":"Ongoing","city":"Versailles","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99404","recalling_firm":"Midmark Corporation","address_1":"60 Vista Dr","address_2":"N/A","postal_code":"45380-9488","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the country of Canada.","recall_number":"Z-3012-2026","product_description":"Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062  Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.","product_quantity":"3624 units","reason_for_recall":"A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.","recall_initiation_date":"20260720","center_classification_date":"20260825","report_date":"20260902","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.  Serial Numbers: 480000   4820704  UDI-DI: 00841709100581, 00841709100321, 00841709100895, 00841709100901"},{"status":"Ongoing","city":"Versailles","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99404","recalling_firm":"Midmark Corporation","address_1":"60 Vista Dr","address_2":"N/A","postal_code":"45380-9488","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the country of Canada.","recall_number":"Z-3013-2026","product_description":"Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080  Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.","product_quantity":"3624 units","reason_for_recall":"A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.","recall_initiation_date":"20260720","center_classification_date":"20260825","report_date":"20260902","code_info":"Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark Digital ECG. The Midmark 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.  Serial Numbers: 7817519   7817645, L1130587   V2967564  UDI-DI: 00841709121319, 08056732652491"}]}}