TemporaryFDAOngoing
Can cause harm that is usually temporary.
Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
Check the device or its packaging for
Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark IQecg Digital ECG. The Midmark IQecg 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: 480000 4820704 UDI-DI: 00841709100581, 00841709100321, 00841709100895, 00841709100901
- Why
- A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
- Distributed
- Worldwide distribution - US Nationwide and the country of Canada.
- Company
- Midmark Corporation
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3012-2026 · retrieved 25 August 2026
Read the official notice