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Use caution Medical device recall · FDA · Published October 27, 2025

Philips Azurion R3.0 X-ray System Recall: Missing SSD Spacer Risk

Philips recalls Azurion R3.0 interventional fluoroscopy systems (model 722234) shipped between July 2024 and June 2025 due to missing SSD spacer, which could fail FDA safety requirements for source-skin distance.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0597-2026Medical devicePhilips ›
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Contact the company

Recalling firmPhilips North America222 Jacobs St · Cambridge, MA 02141-2296
✎ GovInfoNow plain-language explainer

Philips is recalling Azurion R3.0 interventional fluoroscopy systems (model 722234) that were shipped without the required SSD spacer between July 2024 and June 2025. This spacer is critical for meeting FDA safety standards for X-ray source-skin distance, and its absence could lead to potential safety issues during medical procedures. Read more at govinfonow.com/recall/50994-philips-azurion-r3-0-x-ray-system-recall-missing-ssd.

Source Summary by GovInfoNow · govinfonow.com/recall/50994-philips-azurion-r3-0-x-ray-system-recall-missing-ssd · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0597-2026

Cite this page

“Philips Azurion R3.0 X-ray System Recall: Missing SSD Spacer Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50994-philips-azurion-r3-0-x-ray-system-recall-missing-ssd. Based on FDA recall #Z-0597-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0597-2026%22&limit=1).

The FDA announced on Oct. 27, 2025, that Philips North America is recalling Azurion R3.0 interventional fluoroscopic X-ray systems due to a missing safety component. The recall affects units shipped between July 2024 and June 2025.

How to tell if you have it

  • Brand: Philips
  • Product: Azurion R3.0, Commercial Name Azurion 7 M20
  • Model Number: 722234
  • Reference C&R: 2025-IGT-BST-016
  • Units affected: 110

The hazard

The recalled systems were shipped without the Source-to-Skin Distance (SSD) Spacer. This component is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.

Context

GovInfoNow's records show Philips North America has issued 30 other recalls since Dec. 24, 2020. Recent similar product recalls include the Philips Azurion X-Ray System Recall on June 17, 2026, and the Philips Allura Cardio Vascular-Allura Centron X-Ray System Recall on June 17, 2026.

How to tell if you have this one

Check for the model number 722234 on the system, which is labeled as 'Azurion 7 M20'. The recall covers systems shipped by Philips North America between July 2024 and June 2025.

  • Brand
    Philips
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check for Missing SSD Spacer

    Inspect the FlexArm stand for the presence of the Source-to-Skin Distance (SSD) spacer, which was shipped without it between July 2024 and June 2025.

How this recall unfolded

Recall timeline

FDA published this recall 51 days after the firm started it.

1. Firm started the recall: Oct 27, 202512. FDA classified it Class II: Dec 9, 202523. Published in FDA’s Enforcement Report: Dec 17, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0597-2026 (October 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0597-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA