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Open, Classified

Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM

FDA Recall Z-0597-2026 · Posted 2025-12-09

Recalling FirmPhilips North America
Recall StatusOpen, Classified
Product CodeJAA
Date Initiated2025-10-27
Product Quantity110

Reason for Recall

Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.

Firm Action

Philips will send a customer notification to the users of the affected systems to alert them of the issue and provide the actions that should be taken to prevent risks to patients. Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit their site and install the SSD spacer to resolve the issue.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

U.S.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020-05-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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