Class II

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

Philips North America · October 27, 2025

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.

Distribution

U.S.

Quantity Affected

110

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0597-2026

Status: ongoing

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