BEUDAMED
    FDA Enforcement Class II Terminated

    Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    Recall: Z-0402-2018 · Reported January 31, 2018

    Enforcement

    Recall Number
    Z-0402-2018
    Event ID
    78830
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 31, 2018
    Initiation Date
    July 11, 2017
    Classification Date
    January 23, 2018
    Termination Date
    July 2, 2019
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    Reason

    Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.

    Code Info

    Brilliance iCT 4.1.6 version. Brilliance iCT SP - Model 728311 Codes: 200038 200203 200119 200052 200206 200210 200208 200213 200097 200100 200063 200009 200011 200204 200212 200018 200207 200027 200130 83001 200209 200215 200043 200032 200200 200051 200086 200202 200211 200024 200023 200068 200201 200017 200061 200205 200030 200117 200044 200015 83000 200022 200093 200101 200040 200013 200107 200111 200138 200214 200102 200047 200019 200105 200109 200121 200041 200131 200127 200003 200092 200074 200088 200067 200089 200049

    Distribution

    Worldwide distribution, including US nationwide.

    Quantity

    559 total