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Recall Observatory FDA recall evidence

Device product

Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x

Z-0737-2022

February 02, 2022

Class II

Product summary

Firm
Philips Healthcare
Event
Event 89750
Status
Terminated
Classification
Class II
Quantity
42 Systems
Official record key
device-enforcement:Z-0737-2022

Official wording

Reason: 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.

Code information: Azurion R2.1

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.