Class IIDeviceOngoing

Midmark Corporation

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 for recall

A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

Details

Recall number: Z-3013-2026
Event ID: 99404
Recall initiated: Jul 20, 2026
Classified: Aug 25, 2026
Reported: Sep 2, 2026
Quantity: 3624 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Versailles, OH, United States
Lot / code info: 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