FDAFDA · Food and drugs·Recall number Z-3013-2026
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.
Published September 2, 2026 · Recall initiated: July 20, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Midmark Corporation
- Distributor
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.