Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Philips StentBoost Live R2.0 application Recalled by Philips Healthcare Due to Due to an incorrect configuration setting in the...
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 Healthcare directly.
Affected Products
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Quantity: 42 Systems
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Healthcare
Philips Healthcare has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report