FDA-Device2026-09-02Class IIPROCESSING DEFECT
Midmark Digital ECG HD+12 and HD+15 recalled for inaccurate heart rhythm readings
What this means
Certain Midmark Digital ECG machines running older software versions may display incorrect heart rhythm patterns and calculate inaccurate heart rates. This is due to a software communication issue that could affect the accuracy of patient test results.
- Check if your Midmark Digital ECG is running IQecg Plugin software version 10.0 or earlier
- Update to software version 10.1.0.18 or later
- Contact Midmark Corporation for technical support if you are unsure of your software version
The agency's original wording
Hazard
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
3624 units
Manufactured in
60 Vista Dr, N/A, Versailles, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3013-2026More Midmark recalls
- FDA-Device2026-09-30Midmark IQvitals Zone vital signs monitor recalled for inaccurate blood pressure readings
- FDA-Device2026-09-30Midmark IQvitals Zone blood pressure monitor recalled for inaccurate readings
- FDA-Device2026-09-30Midmark IQvitals Zone vital signs monitor recalled for inaccurate blood pressure readings
- FDA-Device2026-09-30Midmark IQvitals Zone vital signs monitor recalled for inaccurate blood pressure readings
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.