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Health Canada Medical devices

Azurion 7 System

Issued January 5, 2024
Issue
Philips has become aware of a potential safety issue with the Philips Azurion Systems R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2, where the system may exhibit a loss of imaging functionality and data. Philips has identified a potential issue which can cause the system to continuously restart (restart loop). T his is likely to occur when the patient database gets too big over time (>500 studies). If this issue occurs, a potential for data loss may be expected. Recall start date: December 15, 2023
Hazard description
Performance
Product
Product name
Azurion 7 System
Reference
ID
RA-74861