Midmark IQecg Digital ECGRecalls & reported problems across all models
Midmark Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Midmark IQecg Digital ECG model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 4 models of Midmark IQecg Digital ECG by Midmark Corporation in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Oct 27, 2020 and Oct 27, 2020 — classified as 1 injury.
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Midmark IQecg Digital ECG recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 20, 2026Open, 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 · names 4 of these models · Recall details · FDA record ↗
Most reported Midmark IQecg Digital ECG problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Stroke/CVA1
Midmark IQecg Digital ECG models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Midmark IQecg® Digital ECG 1-100-1330Electrocardiograph1 recall1 report
- Midmark IQecg® Digital ECG 4-000-0062Electrocardiograph1 recall0 reports
- Midmark IQecg® Digital ECG 4-000-0061Electrocardiograph1 recall0 reports
- Midmark IQecg® Digital ECG 1-100-1325Electrocardiograph1 recall0 reports
Recent Midmark IQecg Digital ECG adverse event reports
The 1 most recent reports across all models, 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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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