Midmark IQecg® Digital ECG 1-100-1330Recalls & reported problems
Midmark Corporation · The IQecg® from Midmark is an easy-to-use, digital, 12-lead resting ECG solution that helps you quickly administer testing and access patient test results you need to make informed cardiac assessments and provide more efficient patient care. · Class 2
All models of Midmark IQecg Digital ECG (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841709100581), received between Oct 27, 2020 and Oct 27, 2020 — classified as 1 injury.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jul 20, 2026Class IIOpen, Classified
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
Z-3012-2026 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Stroke/CVA1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A MISDIAGNOSIS OCCURRED DUE TO A WANDERING BASELINE AND A P-WAVE THAT WAS MISSING FROM THE ECG REPORT. THE PATIENT SUFFERED A STROKE. THE CUSTOMER WAS CONTACTED AND THE. CAR FILE WAS SENT. THE FILE WAS ANALYZED BY THE PRINCIPLE BIOMEDICAL ENGINEER AT MIDMARK. THE FILE WAS REVIEWED, AND THE PATIENT HAD ANTERIOR MYOCARDIAL INFARCTION WHICH THE SOFTWARE HAD DETECTED. MIDMARK'S PHYSICIAN'S GUIDE STATES: WHEN THE EVIDENCE OF ABNORMALITY IS ON THE BORDERLINE WITH SIGNAL ARTIFACTS, HUMAN INTELLIGENCE IS NEEDED. THE COMPUTER ANALYSIS RESULT IS JUST A SECOND OPINION FOR THE PHYSICIANS, IT IS NOT A REPLACEMENT OF A TRAINED PROFESSIONALS READING AND JUDGEMENT. MULTIPLE ATTEMPTS WERE MADE BY MIDMARK TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION ABOUT THE PATIENT.
Patient problems: Stroke/CVA
MAUDE report 10741824 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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