Midmark Corporation: Electrocardiograph
Recall Summary Midmark Corporation is recalling its IQecg Digital ECG devices (models 4-000-0061 and 4-000-0062) with software versions v10 and earlier due to a communication issue that can cause the device to display incorrect heart rhythm patterns and inaccurate heart rate measurements. The recall affects devices distributed across the United States, Canada, and worldwide. Healthcare facilities and providers using these ECG machines should check their software versions to determine if they are affected.
- Recalling firm
- Midmark Corporation
- Product
- 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.
- Reason
- A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-20
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/0d27ace8-27fd-4d20-ba4b-f570a7254bf8