Device recall
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.
- Recall number
- Z-3013-2026
- 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
- DRG
- Device type
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- 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 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
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K220526
- Location
- Versailles, OH, United States