Midmark Digital ECG HD+12, HD+15, Model/Catalog Number recall
Midmark Corporation recalled Midmark Digital ECG HD+12, HD+15, Model/Catalog Number on September 2, 2026 because of a communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. It was sold nationwide.
Why it was recalled
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
What's recalled
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.
Quantity: 3624 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Midmark Corporation, Versailles, OH
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Worldwide distribution - US Nationwide and the country of Canada. - Status
- Ongoing
- Recall number
- Z-3013-2026
- Source
- U.S. Food and Drug Administration
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