Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDADigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.2026-05-01
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