BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0841-2018 · Initiated January 11, 2018

    Recall

    Recall Number
    Z-0841-2018
    Event Number
    79148
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 11, 2018
    Terminated
    May 20, 2019
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    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.

    Action

    Philips Healthcare is notifying the affected users of these issues via a Field Safety Notice and will be releasing a software fix via Field Change Order to correct these issues. They also provide the following instructions.: Issue 1, Uric acid application for gout provides inconsistent results - When reviewing images using the Uric Acid Spectral Result type inconsistent results were provided on gout studies. The tendons would occasionally be displayed as containing Uric Acid even with no or normal uric acid blood levels. Issue 2, Multi-phase Cardiac CTA Scans should include a planned conventional result for every planned spectral result - When planning a Cardiac multi-phase study, it is possible to create a phase that consists of only a Spectral Result. Issue 3, 0-MAR information is missing in DICOM when saving as original or Secondary Capture - When an SBl that was created with 0-MAR enabled is used to create and save any Spectral result: " DICOM information about 0-MAR is missing but the 0-MAR label appears on a result saved as Original " DICOM information and the 0-MAR label are both missing on a result saved as Secondary Capture Issue 4, Attenuation plot presents incorrect HU values for MonoE - When comparing HU values of an ROl to the values in the attenuation plot graph when using the Show spectral plots for this ROI option, there is a difference of 10-20 HU values between the ROI HU value and the value shown on the graph Issue 5, Windows Operating System Time Zone Updates - Microsoft Windows Daylight Savings Time Zone updates have not been applied since December 2014. This may cause the system time to be incorrect at the start and end of daylight savings time. Issue 6, Sending Calcium Score findings to report using Mass Score protocol provides confusing information - The Heartbeat CS (Calcium Scoring) option provides confusing information in the Impressions section of the Calcium Scoring report. The report provides m

    Distribution

    Domestic and Foreign

    Quantity

    63