Midmark Corporation recalls Midmark Digital ECG HD+12
- Recalling company
- Midmark Corporation
- Product
- 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.
- 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 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
- Company location
- Versailles, OH
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3013-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3013-2026 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.