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Health Canada Medical devices

Artis Pheno System

Issued September 28, 2022
Issue
The Artis Pheno System is provided with a dedicated error management mechanism. In rare cases of specific X-ray tube failures, the system is intended to automatically switch over to "bypass fluoroscopy" mode. However, in case such a failure occurs while the "block radiation" functionality is active, the "block radiation" functionality cannot be unlocked, and the system will not switch over to "bypass fluoroscopy" mode. In "bypass fluoroscopy" mode a limited imaging functionality (nonsubtracted, Continuous fluoroscopy with reduced power and without acquisition and storage of images) would remain available. Recall start date: September 23, 2022
Hazard description
Performance
Product
Product name
Artis Pheno System
Reference
ID
RA-64587