BEUDAMED
    FDA Enforcement Class II Completed

    Azurion systems with software release R2.0.x

    Recall: Z-0734-2022 · Reported March 30, 2022

    Enforcement

    Recall Number
    Z-0734-2022
    Event ID
    89742
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Philips Healthcare
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    March 30, 2022
    Initiation Date
    May 26, 2021
    Classification Date
    March 23, 2022
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Azurion systems with software release R2.0.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

    Model(s) Azurion R2.1

    Distribution

    US Nationwide Distribution

    Quantity

    69 systems