BEUDAMED
    FDA Recall Open, Classified

    Agfa HealthCare Enterprise Imaging XERO Viewer

    Recall: Z-1004-2023 · Initiated December 5, 2022

    Recall

    Recall Number
    Z-1004-2023
    Event Number
    91357
    Firm
    Agfa Healthcare NV Septestraat 27 Mortsel Belgium
    FEI Number
    3009471886
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    December 5, 2022
    Posted
    January 20, 2023

    Description

    Agfa HealthCare Enterprise Imaging XERO Viewer

    Reason

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

    Action

    On December 5th, 2022, a customer letter ("Mandatory Product Correction Notification") was mailed to 40 United States of America affected consignees. The letter informed the customers about the issue and outlined the planned corrective actions. Acknowledgment, via email, that the information was received and understood was requested from the consignees. A Mandatory Service Bulletin was released to provide documentation to Agfa Healthcare services on how to deploy the correction for Enterprise Imaging XERO Viewer for the affected customer sites. Agfa HealthCare Service is reaching out to the affected customers to schedule and apply appropriate software correction.

    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