Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Philips Allura (Model Numbers 722010 Recalled by Philips North America Llc Due to Due to a software defect, the Philips StentBoost...

Date: February 2, 2022
Company: Philips North America Llc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips North America Llc directly.

Affected Products

Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0

Quantity: 338

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips North America Llc

Philips North America Llc has 301 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report