—#161445

Product

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

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K133674
Affected lot / 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

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Domestic and Foreign

Timeline

Recall initiated: 2018-01-11
Terminated: 2019-05-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161445. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.