Midmark IQecg Digital ECG Recall Issued for Software Anomaly
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Midmark Corporation is recalling 3624 units of Midmark IQecg Digital ECG devices due to a communication anomaly that may produce incorrect ECG waveforms and inaccurate beats-per-minute calculations.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 9, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.", distributed worldwide distribution - us nationwide and the country of canada.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
A communication anomaly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
Which Products Are Affected
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. 3624 units. Lot Code/Serial Numbers: 480000 4820704. UDI-DI: 00841709100581, 00841709100321, 00841709100895, 00841709100901. Distributed worldwide including US Nationwide and Canada. Recall number: Z-3012-2026. Recalling firm: Midmark Corporation, 60 Vista Dr, Versailles, OH 45380-9488.
What You Should Do
Contact Midmark Corporation regarding this recall.
Why This Matters
This ongoing Class II recall affects 3624 units of diagnostic ECG devices distributed across the United States and Canada.
Source
FDA recall Z-3012-2026. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (905 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.