Midmark recalls specific IQecg ECG models with outdated software that may show incorrect heart rate readings. Affected units include certain serial numbers and software versions. Update to v10.1.0.18 or later to fix.
“Midmark IQecg ECG Software Error: Incorrect Heart Rate Readings.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697860-midmark-iqecg-ecg-software-error-incorrect-heart-rate-readings. Based on FDA recall #Z-3012-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3012-2026%22&limit=1).
The FDA announced on July 20, 2026, that Midmark Corporation is recalling its IQecg Digital ECG systems due to a software anomaly that may produce incorrect electrocardiogram waveforms and inaccurate heart rate calculations. This voluntary Class II recall affects units distributed in the U.S. and Canada.
How to tell if you have it
Brand: Midmark
Product: 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
Distribution: Worldwide (U.S. Nationwide and Canada)
Units Affected: 3624
The hazard
According to the FDA, a communication anomaly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
Context
GovInfoNow's records show Midmark Corporation has one other recall on record since August 21, 2026, involving the IQvitals Zone Blood Pressure Device which risked inaccurate readings. Other recent recalls of similar products include GE Medical Systems ECG Systems Software Error Risks Patient Data Mix-Up (April 21, 2026), Philips Cardiac Workstation 5000: Inaccurate Heart Rate Data Risk (July 1, 2026), and Boston Scientific LUX-DX II Arrythmia Detector Recall: Missing Heart Monitoring Data (March 30, 2026).
How to tell if you have this one
Check if your device has a serial number starting with 480000 or 4820704. Software versions starting with v10 but before v10.1.0.18 are affected. The device may have lot codes 00841709100581, 00841709100321, 00841709100895, or 00841709100901.
Brand
Midmark
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Recall number
Product, codes & lots
Z-3012-2026
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.; Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark IQecg Digital ECG. The Midmark IQecg Digital ECG system information is provided below. The total quantities manufactured and distributed noted below are the combined IQecgs Digital ECG and Midmark Digital ECG systems. Serial Numbers: 480000 4820704 UDI-DI: 00841709100581, 00841709100321, 00841709100895, 00841709100901
Z-3013-2026
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.; Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark Digital ECG. The Midmark Digital ECG system information is provided below. The total quantities manufactured and distributed noted below are the combined IQecgs Digital ECG and Midmark Digital ECG systems. Serial Numbers: 7817519 7817645, L1130587 V2967564 UDI-DI: 00841709121319, 08056732652491
Based on the official FDA remedy
What to do — step by step
Update Software
Install software version v10.1.0.18 or later to correct the error.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3012-2026 (July 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3012-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.