CanadaThe affected product is Midmark Corporation’s IQecg® Digital ECG (model/catalogue numbers 4-000-0061 and 4-000-0062; software SW v10–v10.1.0.17). The affected plugin software may produce incorrect ECG waveforms and inaccurate heart-rate calculations, so users should manually assess the patient’s heart rate before initiating therapeutic intervention, use the temporary workaround if the issue occurs, contact Midmark for more information, and await coordinated installation of corrected software.
What's being recalled
Companies: Midmark Corporation, 60 Vista Drive, Versailles, Ohio, United States, 45380.
How to identify it
Affected products: IQecg® Digital ECG; Lot or serial number: SW v10-v10.1.0.17; Model or catalogue number: 4-000-0061
Affected products: IQecg® Digital ECG; Lot or serial number: SW v10-v10.1.0.17; Model or catalogue number: 4-000-0062
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States