BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0737-2022 · Initiated February 2, 2022

    Recall

    Recall Number
    Z-0737-2022
    Event Number
    89750
    Firm
    Philips Healthcare
    FEI Number
    1218950
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    February 2, 2022
    Terminated
    November 5, 2024
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    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.

    Action

    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.

    Distribution

    US Nationwide distribution.

    Quantity

    42 Systems