Use caution Medical device recall · FDA · Published November 12, 2021

Philips Azurion X-ray System Start-Up Issue: Risk of Movement Problems

Philips recalls Azurion Interventional Fluoroscopic X-ray Systems with specific model numbers due to start-up communication issues and emergency stop recovery problems that may cause movement failures.

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

🇺🇸 FDA recall #Z-0471-2022Medical device Philips ›

Use caution until it’s fixed

(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available

Take action

Contact the company

Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289

✎ GovInfoNow plain-language explainer

Philips is recalling certain Azurion Interventional Fluoroscopic X-ray Systems with model numbers 722221, 722228, 722225, 722068, 722226, 722078, and 722224. These systems have a start-up communication problem that can cause movement failures, which may lead to unsafe operation during medical procedures. Read more at govinfonow.com/recall/61539-philips-azurion-x-ray-system-start-up-issue-risk-of.

Source Summary by GovInfoNow · govinfonow.com/recall/61539-philips-azurion-x-ray-system-start-up-issue-risk-of · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0471-2022

Cite this page

“Philips Azurion X-ray System Start-Up Issue: Risk of Movement Problems.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61539-philips-azurion-x-ray-system-start-up-issue-risk-of. Based on FDA recall #Z-0471-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0471-2022%22&limit=1).

The FDA announced on 2021-11-12 that Philips North America Llc is recalling its Azurion Interventional Fluoroscopic X-ray Systems due to start-up and emergency stop recovery issues. The recall affects 10 units distributed in the U.S., France, Germany, Japan, Poland, and the United Kingdom.

How to tell if you have it

Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2
Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224
UPCs: 00884838085251, 00884838085367, 00884838099203, 00884838099234, 00884838099258, 00884838099265, 00884838099272

The hazard

The systems may experience intermittent start-up problems where the communication of the control unit managing stand movement is not established. Additionally, warm restarts after an emergency stop may not execute correctly, leaving movement functionality unavailable.

Context

GovInfoNow's records show Philips North America Llc has issued 129 other recalls since 2017-07-12. Recent recalls include the Evolution upgrade 1.5T and 3.0T (2026-08-21), the Spectral CT 7500 Scanner (2026-08-18), and Ingenuity CT Scanners (2026-08-07). Other recent recalls of similar products include Philips Azurion 7 B12 X-ray System May Not Start Correctly (2026-03-03), Philips Azurion 5 M12 X-ray System May Not Start Properly (2026-03-03), and Philips Azurion 7 B20 X-ray System May Not Start Properly (2026-03-03).

How to tell if you have this one

Check for model numbers 722221, 722228, 722225, 722068, 722226, 722078, or 722224 on the device. The system may have a serial number (S/N) and unique device identifier (UDI) as listed in the recall notice.

Brand
Philips
Product
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check System Model
Identify the model number on the device to confirm if it is one of the recalled numbers: 722221, 722228, 722225, 722068, 722226, 722078, or 722224.
Contact Philips Support
Reach out to Philips customer support for guidance on next steps if the device is affected by the recall.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the state of WA and the countries of France, Germany, Japan, Poland, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Nov 12, 2021Firm started the recall
Jan 10, 2022FDA classified it Class II
Jan 19, 2022Published in FDA’s Enforcement Report
Feb 5, 2024FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/61539-philips-azurion-x-ray-system-start-up-issue-risk-of">Philips Azurion X-ray System Start-Up Issue: Risk of Movement Problems (GovInfoNow)</a>

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-0471-2022 (November 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0471-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.