FDA-Device2026-09-02Class IIPROCESSING DEFECT
Midmark IQecg Digital ECG recalled for software communication error affecting heart readings
What this means
Midmark IQecg Digital ECG devices running certain software versions (v10 through v10.1.0.17) may display incorrect heart rhythm patterns and calculate inaccurate heart rates due to a communication error. This could lead to misdiagnosis or delayed treatment if abnormalities are missed.
- If you operate a Midmark IQecg Digital ECG, contact Midmark Corporation for a software update to version v10.1.0.18 or later
- Do not rely on readings from affected devices until the update is installed
- Check your device's software version in the system information menu
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 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3012-2026More Midmark recalls
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- 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
- FDA-Device2026-09-02Midmark Digital ECG HD+12 and HD+15 recalled for inaccurate heart rhythm readings
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