IQecg® Digital ECG
Brand(s)
Last updated
Summary
Product
IQecg® Digital ECG
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| IQecg® Digital ECG | SW v10-v10.1.0.17 | 4-000-0061 |
| IQecg® Digital ECG | SW v10-v10.1.0.17 | 4-000-0062 |
Issue
Affected IQecg® plugin software may produce incorrect ECG waveforms and inaccurate heart-rate calculations. Until corrected software is installed, users should manually assess the patient's heart rate before initiating therapeutic intervention and use the temporary workaround if the issue occurs. Midmark will coordinate installation of the corrected software.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Midmark Corporation
60 Vista Drive, Versailles, Ohio, United States, 45380
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82412
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