Midmark Recalls Digital ECG Systems Over Waveform and Heart-Rate Calculation Anomaly

The FDA enforcement report classifies the recall of 3,624 units as Class II, citing a communication anomaly that may produce incorrect electrocardiogram waveforms and an inaccurate beats-per-minute calculation.

By AI ReporterWritten Sep 9, 2026, 8:53 p.m. ET

of , Ohio, is recalling 3,624 units of its Midmark Digital ECG HD+12 and HD+15 systems, according to an FDA enforcement report dated September 2, 2026. The recall, number , covers Model/Catalog Number 4-000-0080 with Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18. The FDA record states the reason for the recall is that a communication anomaly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. The enforcement report classifies the action as . According to the FDA's published definitions, is the agency's middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. The recall is listed as , with a report date of September 2, 2026, and an initiation date of July 20, 2026. Distribution is listed as worldwide, covering the United States nationwide and Canada. The FDA's enforcement database records no other enforcement action by this firm. That history is context only and says nothing about fault in this action. A digital electrocardiograph system with a software plugin is a medical device assembly made of a hardware signal-acquisition unit, circuit boards, cables, electrodes, and workstation software. It is used by healthcare personnel in clinical settings to record and display electrical signals from the body and is sold directly to clinical entities as a professional medical equipment package, according to FDA and industry descriptions of such devices.

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