Midmark Digital ECG Software Recall for Incorrect Waveform Display
Midmark is recalling Digital ECG HD+12 and HD+15 units with specific IQecg plugin software versions due to a communication anomaly that may cause incorrect ECG 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, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Midmark Corporation is recalling 3,624 units of Midmark Digital ECG HD+12 and HD+15 devices (Model/Catalog Number: 4-000-0080). The recall affects units equipped with Midmark IQecg Plugin software versions starting with v10 and prior to v10.1.0.18. These devices were distributed nationwide in the United States and in Canada.
The recall is being issued because a communication anomaly may result in incorrect electrocardiogram (ECG) waveforms of a patient and an inaccurate beats-per-minute calculation. This software defect could lead to inaccurate diagnostic data for patients using the affected devices.
Healthcare facilities and users should check their device software versions and serial numbers against the recall information provided by Midmark. Affected serial numbers include 7817519, 7817645, L1130587, and V2967564. Users should contact Midmark Corporation for instructions on how to update the software or resolve the issue.
The recalled product
- Product
- 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.
- 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 (2)
- L1130587 V2967564 UDI-DI: 00841709121319
- 08056732652491
Distribution
Distributed nationwide across the United States.
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