Philips Healthcare Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Brand
Philips Healthcare
Lot Codes / Batch Numbers
Azurion R2.1
Products Sold
Azurion R2.1
Philips Healthcare is recalling Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R due to Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Philips notified customers of the issue via an Electronic Product Radiation Defect notification letter dated February 2, 2022. Philips will schedule an appointment with customers to install the software update. Philips will correct the affected systems at no cost to customers with a software upgrade. For information contact your local Philips representative: 1-800-722-9377.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026