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FDA-Device2025-12-17Class IIPACKAGING DEFECT

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

Philips
BURNNationwide distribution

Check your Philips Azurion 7 M20 X-ray system

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
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.

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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