Official recall record

Azurion 7 System

Health Canada — Medical Devices · 2024-01-05 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2024-01-05
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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