Midmark Digital ECG HD+12 recall (Midmark Corporation)
Medical deviceClass IIOngoing
Summary: Midmark Corporation is recalling 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.
What is being recalled
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.
Why
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the country of Canada.
How to tell if yours is affected
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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3013-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 20, 2026 |
| Reported | September 2, 2026 |
| Company | Midmark Corporation |
| Company location | Versailles, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3624 units |
More recalls from Midmark Corporation · all medical device recalls · recalls from July 2026