BEUDAMED
    FDA Enforcement Class II Terminated

    Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2

    Recall: Z-1997-2019 · Reported August 7, 2019

    Enforcement

    Recall Number
    Z-1997-2019
    Event ID
    83366
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems Nederlands
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    August 7, 2019
    Initiation Date
    November 30, 2018
    Classification Date
    July 30, 2019
    Termination Date
    March 27, 2024
    Address
    Veenpluis 4-6, N/A, Best, N/A, N/A, Netherlands

    Description

    Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2

    Reason

    Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images.

    Code Info

    software version R1.2

    Distribution

    Nationwide

    Quantity

    229