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

Philips StentBoost Live R2.0: Incorrect Configuration Causes Acquisition to Continue

Philips recalls StentBoost Live R2.0 software for Azurion systems with R2.x software due to incorrect EPX database configuration causing acquisition to continue after 40 images instead of stopping automatically.

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

🇺🇸 FDA recall #Z-0737-2022Medical device Philips Healthcare ›

Lower-risk recall

Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on the Philips Azurion system, the following on-screen message is displayed to the user in the Philips StentBoost Live application: "Press the cine pedal until the acquisition stops". However, due to the incorrect configuration of the EPX database, the acquisition does not stop after 40 images, but instead it continues as long as the pedal is pressed.

Take action

Contact the company

Recalling firmPhilips Healthcare3000 Minuteman Rd · Andover, MA 01810-1032

✎ GovInfoNow plain-language explainer

Philips is recalling StentBoost Live R2.0 software for use with Azurion systems running R2.x software. The issue causes imaging to continue after 40 images instead of stopping automatically, which could lead to incomplete scans or unnecessary radiation exposure. Read more at govinfonow.com/recall/61186-philips-stentboost-live-r2-0-incorrect-configuration-causes-acquisition-to.

Source Summary by GovInfoNow · govinfonow.com/recall/61186-philips-stentboost-live-r2-0-incorrect-configuration-causes-acquisition-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0737-2022

Cite this page

“Philips StentBoost Live R2.0: Incorrect Configuration Causes Acquisition to Continue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61186-philips-stentboost-live-r2-0-incorrect-configuration-causes-acquisition-to. Based on FDA recall #Z-0737-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0737-2022%22&limit=1).

The FDA announced on Feb. 2, 2022, that Philips Healthcare recalled the StentBoost Live R2.0 application used with Philips Azurion systems due to a configuration error preventing automatic image acquisition stoppage. This defect poses a risk of excessive radiation exposure during procedures.

How to tell if you have it

Philips StentBoost Live R2.0 application
Philips Azurion with software release R2.x
Azurion R2.1

The hazard

An incorrect configuration setting in the EPX database causes acquisition to continue as long as the cine pedal is pressed, rather than stopping after 40 images. The on-screen message instructs users to press the pedal until acquisition stops, but the system fails to halt automatically.

Context

GovInfoNow's records show Philips Healthcare has issued six other recalls since June 11, 2018. Other recent recalls of similar products include Philips Azurion System Software R3.1 May Cause Imaging Loss (Dec. 12, 2025), Philips Azurion Systems R3.0 Software Issues: Risk of Image Loss and System Failures (Dec. 8, 2025), and Philips Azurion 7 B20 X-ray System May Not Start Properly (March 3, 2026).

How to tell if you have this one

Check if you have Philips StentBoost Live R2.0 software installed on Azurion systems with R2.x software. The affected software version is identified by the Azurion R2.1 update.

Brand
Philips Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your Azurion system software version and StentBoost Live application version to confirm if you are affected.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.8 years after the firm started it.

Feb 2, 2022Firm started the recall
Apr 5, 2022FDA classified it Class II
Apr 13, 2022Published in FDA’s Enforcement Report
Nov 5, 2024FDA terminated the recall

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

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Keep exploring

More Philips Healthcare recalls

Link to this recall

<a href="https://govinfonow.com/recall/61186-philips-stentboost-live-r2-0-incorrect-configuration-causes-acquisition-to">Philips StentBoost Live R2.0: Incorrect Configuration Causes Acquisition to Continue (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-0737-2022 (February 2, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0737-2022 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.