- Recalling firm
- Midmark Corporation
- Reason for recall
- A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
- Affected products (lot / model / serial)
- 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
- Units affected
- 3624 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the country of Canada.
- Firm location
- Versailles, OH, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3013-2026
- Recall initiated
- July 20, 2026
- FDA classification date
- August 25, 2026
- FDA report date
- September 2, 2026
- FDA event ID
- 99404
- Last updated on HTM Vibe
- September 8, 2026