Recall MonitorHealth Products
IQecg® Digital ECG
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: IQecg® Digital ECG
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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.