BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0737-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0737-2022
    Event ID
    89750
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Healthcare
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    April 13, 2022
    Initiation Date
    February 2, 2022
    Classification Date
    April 5, 2022
    Termination Date
    November 5, 2024
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

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

    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 Info

    Azurion R2.1

    Distribution

    US Nationwide distribution.

    Quantity

    42 Systems