Lower risk Medical device recall · FDA · Published February 2, 2022

Philips Allura and Azurion Medical Imaging Systems with StentBoost Live R2.0 Software

Philips recalls specific Allura and Azurion models with StentBoost Live R2.0 software that may show incorrect X-ray images from previous runs instead of current patient scans.

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

🇺🇸 FDA recall #Z-0874-2022Medical device Philips ›

Lower-risk recall

Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Philips is recalling certain Allura and Azurion medical imaging systems that have a software defect in the StentBoost Live R2.0 version. This defect may cause the system to display X-ray images from a previous run instead of the current patient's scan, potentially showing images from a different patient. This could lead to misdiagnosis if the images are used for treatment decisions. Read more at govinfonow.com/recall/61188-philips-allura-and-azurion-medical-imaging-systems-with-stentboost-live.

Source Summary by GovInfoNow · govinfonow.com/recall/61188-philips-allura-and-azurion-medical-imaging-systems-with-stentboost-live · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0874-2022

Cite this page

“Philips Allura and Azurion Medical Imaging Systems with StentBoost Live R2.0 Software.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61188-philips-allura-and-azurion-medical-imaging-systems-with-stentboost-live. Based on FDA recall #Z-0874-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0874-2022%22&limit=1).

The FDA announced on Feb. 2, 2022, that Philips North America LLC is recalling Philips Allura and Philips Azurion medical devices due to a software defect. The hazard involves the StentBoost Live R2.0 software potentially displaying X-ray images from previous runs instead of current ones.

How to tell if you have it

Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035)
Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228)
StentBoost Live (Model Number 459801781661) Software Version Number: R2.0
UPCs: 00884838054189, 00884838054196, 00884838054202, 00884838054219, 00884838054240, 00884838059030, 00884838059054, 00884838085251, 00884838085268, 00884838085275, 00884838085282, 00884838085350, 00884838085367, 00884838099203, 00884838099210
Global Distribution. US Nationwide.
338 units affected.

The hazard

Context

GovInfoNow's records show Philips North America LLC has had 129 other recalls on record since July 12, 2017. Other recent recalls of similar products include Philips Azurion System Software R3.1 May Cause Imaging Loss (Dec. 12, 2025) and Philips Azurion Systems R3.0 Software Issues: Risk of Image Loss and System Failures (Dec. 8, 2025).

How to tell if you have this one

Check if your Philips Allura (model numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) or Philips Azurion (model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) systems have StentBoost Live software version R2.0 (model number 459801781661).

Brand
Philips
Product
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your system's software version by checking the model number and software version on the device or in the system settings.
Contact Philips Support
Reach out to Philips customer support for guidance on whether your system is affected and what steps to take next.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Global Distribution. US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

Feb 2, 2022Firm started the recall
Apr 6, 2022FDA classified it Class II
Apr 13, 2022Published in FDA’s Enforcement Report

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/61188-philips-allura-and-azurion-medical-imaging-systems-with-stentboost-live">Philips Allura and Azurion Medical Imaging Systems with StentBoost Live R2.0 Software (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-0874-2022 (February 2, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0874-2022 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.