{"url_path":"/fda/device/recalls/Z-3012-2026","section_key":"summary","section_title":"DEVICE Recall: Midmark Corporation — 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.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-20","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3012-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Midmark Corporation"},"word_count":140,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3012-2026\n\n**Recalling firm:** Midmark Corporation\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-20\n**Report date:** 2026-09-02\n\n## Product\nMidmark 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.\n\n## Reason\nA communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.\n\n## Affected lots\nLot 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\n\n## Distribution\nWorldwide distribution - US Nationwide and the country of Canada."}