Device recall
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.
- Recall number
- Z-3012-2026
- Event id
- 99404
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Midmark Corporation
- Report date
- Sep 2, 2026
- Posted
- Aug 25, 2026
- Initiated
- Jul 20, 2026
- Center classification date
- Aug 25, 2026
- Product code
- DPS
- Device type
- Electrocardiograph
- Reason
- A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
- Root cause
- Software design
- Quantity
- 3624 units
- Code info
- 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
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K103640
- Location
- Versailles, OH, United States