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Health Canada Medical devices

Q-Stress and Xscribe (Version 6 or Higher)

Issued December 21, 2023
Issue
Baxter Corporation is issuing an urgent medical device correction for the Q-Stress and XScribe cardiac stress testing systems (Q-Stress version 6 or higher and XScribe version 6 or higher) due to a potential change in the QRS amplitude identified in electrocardiogram (ECG) readings when the source consistency filter (SCF) is enabled. Recall Start Date: December 3, 2023
Hazard description
Performance
Product
Product name
Q-Stress and Xscribe (Version 6 or Higher)
Reference
ID
RA-74778