Reported Sep 2, 2026 · Ongoing · Updated Sep 7, 2026
Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions…
Midmark Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Midmark Corporation · 60 Vista Dr · Versailles, OH · 45380-9488
Is this the product you have?
Midmark Digital ECG HD+12HD+15
- Model/Catalog Number4-000-0080
- Software VersionMidmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18
- Lot codes and dates
- Lot CodeThis 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 Numbers7817519 7817645
- L1130587 V2967564 UDI-DI
0084170912131908056732652491
- Amount recalled
- 3624 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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