BEUDAMED
    FDA Enforcement Class II Ongoing

    Azurion systems with software release R1.x

    Recall: Z-0886-2022 · Reported May 11, 2022

    Enforcement

    Recall Number
    Z-0886-2022
    Event ID
    89964
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    May 11, 2022
    Initiation Date
    May 26, 2021
    Classification Date
    May 3, 2022
    Address
    Veenpluis 4-6, N/A, Best, N/A, N/A, Netherlands

    Description

    Azurion systems with software release R1.x

    Reason

    In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.

    Code Info

    software release R1.x

    Distribution

    US Nationwide and Worldwide Distribution

    Quantity

    722 systems