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CLASS II · ModerateFDA

Midmark Corporation recalls Midmark IQecg Digital ECG

📅 Jul 20, 2026 · 📍 Nationwide
Recalling company
Midmark Corporation
Product
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.
Reason
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jul 20, 2026
Reported
Sep 2, 2026
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Status
Ongoing
Quantity
3624 units
Lot / codes
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
Company location
Versailles, OH
Recall type
Voluntary: Firm initiated
Recall number
Z-3012-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3012-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.