BEUDAMED
    FDA Enforcement Class II Ongoing

    Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)

    Recall: Z-0238-2022 · Reported December 1, 2021

    Enforcement

    Recall Number
    Z-0238-2022
    Event ID
    89020
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Healthcare
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    December 1, 2021
    Initiation Date
    September 24, 2021
    Classification Date
    November 24, 2021
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)

    Reason

    3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a 3D-RA scan, the detector of the Philips Azurion system must be positioned in portrait or landscape orientation with an angle of 0 or +/-90 degrees relative to the 3D scan direction. Philips has discovered that Azurion releases 2.1(L1) and 2.1(L2) allow creation of a 3D-RA scan with a deviating detector orientation of up to 3 degrees from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees), relative to the 3D scan direction. 3D-RA scans with a deviating detector orientation of ore than 1.0 degree from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees) cannot be reconstructed with the 3D-RA reconstruction software.

    Code Info

    Azurion 2.1(L1) and 2.1(L2)

    Distribution

    US Nationwide distribution

    Quantity

    226 units