Midmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
Midmark is recalling IQecg Digital ECG software due to a communication anomaly that may cause incorrect waveforms and inaccurate heart rate calculations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (inaccurate medical data) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Midmark Corporation is recalling the Midmark IQecg Digital ECG, Model/Catalog Numbers 4-000-0061 and 4-000-0062, specifically for software versions starting with v10 and prior to v10.1.0.18. The recall involves 3,624 units distributed worldwide, including the United States and Canada.
The recall was initiated because a communication anomaly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. This defect could lead to inaccurate clinical data regarding the patient's heart activity.
Healthcare facilities and users should contact Midmark Corporation for instructions on how to correct the software. The recall number is Z-3012-2026.
The recalled product
- 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.
- Manufacturer
- Midmark Corporation
- Affected units
- 3,624
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 00841709100321
- 00841709100895
- 00841709100901
Distribution
Distributed nationwide across the United States.
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