FDA-Device2025-12-17Class IIPACKAGING DEFECT

Philips Azurion 7 M20 X-ray system recalled for missing radiation safety spacer

BURNNationwide distributionMedical devices

What this means

Between July 2024 and June 2025, some Philips Azurion R3.0 fluoroscopic X-ray systems (model 722234) were shipped without a required safety spacer. This spacer ensures the X-ray tube maintains a safe distance from patients during standard fluoroscopy procedures, as required by FDA regulations.

If you operate a Philips Azurion 7 M20 system, contact Philips to verify whether your unit has the Source-to-Skin Distance (SSD) Spacer installed
Reference Philips notice C&R 2025-IGT-BST-016 when contacting Philips
Do not use the system for standard fluoroscopy if the spacer is missing until it is installed

The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

U.S.

Affected count

110

Manufactured in

222 Jacobs St, N/A, Cambridge, MA, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0597-2026

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