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.
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.
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.
The software has an incorrect configuration in the EPX database that prevents the imaging acquisition from stopping automatically after 40 images. Instead, it continues as long as the cine pedal is pressed, potentially causing incomplete scans or unnecessary radiation exposure during procedures.
Medical professionals using Philips StentBoost Live R2.0 software with Azurion systems running R2.x software. Those most at risk are radiologists and technicians performing cardiac imaging procedures.
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.
Verify your Azurion system software version and StentBoost Live application version to confirm if you are affected.
The recall does not indicate that procedures are currently unsafe, but the software issue could lead to incomplete scans or unnecessary radiation exposure.
Check your Azurion system software version and StentBoost Live application version to see if they match the affected versions described in the recall.
The recall does not specify any action steps for users, so contact Philips Healthcare directly for guidance.
We’ve drafted a message you can send Philips Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0737-2022 — Philips Healthcare Philips Healthcare Hello, I own a Philips Healthcare that is covered by recall Z-0737-2022 from Philips Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
