BEUDAMED
    FDA Enforcement Class II Ongoing

    Agfa HealthCare Enterprise Imaging XERO Viewer

    Recall: Z-1004-2023 · Reported February 1, 2023

    Enforcement

    Recall Number
    Z-1004-2023
    Event ID
    91357
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Agfa Healthcare NV
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2023
    Initiation Date
    December 5, 2022
    Classification Date
    January 20, 2023
    Address
    Septestraat 27, N/A, Mortsel, N/A, N/A, Belgium

    Description

    Agfa HealthCare Enterprise Imaging XERO Viewer

    Reason

    There is a software defect that can cause issues with images.

    Code Info

    Affected software versions include: XERO Viewer 8.1.4.100 or higher XERO Viewer 8.2.0.000 or higher XERO Viewer 8.2.1.000 or higher UDI/DI: 05400874000710

    Distribution

    Distribution throughout US OUS distribution to Australia, Belgium, Brazil, Canada, Chile, Cyprus, France, Iceland, Ireland, Italy, Kenya, Luxembourg, Netherlands, Romania, Saudi Arabia, Spain, Sweden, United Kingdom, South Africa

    Quantity

    110 units