FDA recall, , Moderate risk
Midmark Digital ECG HD+12 and IQecg Digital ECG
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
Summary by Recall Canary from the FDA notice
What happened
Midmark Corporation of Versailles, Ohio, recalled its Digital ECG HD+12 and IQecg Digital ECG, the FDA reported. A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. The recall began July 20, 2026, and was added to the FDA's Enforcement Report on August 25, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
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.
- UDI-DI
- 00841709121319
- 08056732652491
- Lot code
- v10
- v10.1.0.18
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.
- UDI-DI
- 00841709100581
- 00841709100321
- 00841709100895
- 00841709100901
- Lot code
- v10
- v10.1.0.18
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the country of Canada.
- Company
- Midmark CorporationVersailles, Ohio
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99404
- Recall numbers
- Z-3012-2026 to Z-3013-2026
All recalls from Midmark Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
