United StatesAzurion R3.0 interventional fluoroscopic X‑ray system (Model 722234, commercial name Azurion 7 M20; Philips Reference C&R 2025-IGT-BST-016) — 110 units shipped in the U.S. — are affected. Systems with a FlexArm stand shipped between July 2024 and June 2025 were missing the Source‑to‑Skin Distance (SSD) spacer needed to meet the FDA minimum SSD requirement of 38 cm for standard fluoroscopy applications.
What's being recalled
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Recalling firm: Philips North America, Cambridge, MA, United States.
How to identify it
Model Number 722234 Commercial Name: Azurion 7 M20 How to identify: Philips Reference C&R 2025-IGT-BST-016
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)