BEUDAMED
    FDA Enforcement Class II Terminated

    IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System

    Recall: Z-0841-2018 · Reported March 14, 2018

    Enforcement

    Recall Number
    Z-0841-2018
    Event ID
    79148
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 14, 2018
    Initiation Date
    January 11, 2018
    Classification Date
    March 2, 2018
    Termination Date
    May 20, 2019
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System

    Reason

    23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images.

    Code Info

    Serial Numbers: 860008 860009 860010 860011 860012 860013 860014 860015 860016 860017 860018 860019 860020 860021 860022 860023 860024 860025 860026 860027 860028 860029 860030 860031 860032 860033 860034 860035 860036 860037 860038 860039 860040 860041 860042 860043 860046 860048 860049 860050 860051 860052 860053 860054 860055 860056 860057 860058 860059 860060 860061 860062 860063 860064 860065 860066 860067 860068 860070 860071 860072 890002 860047

    Distribution

    Domestic and Foreign

    Quantity

    63