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U.S. Department of Health and Human Services

Class 2 Device Recall IQon Spectral CT with 4.7.2 software version.

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  Class 2 Device Recall IQon Spectral CT with 4.7.2 software version. see related information
Date Initiated by Firm January 11, 2018
Create Date March 02, 2018
Recall Status1 Terminated 3 on May 20, 2019
Recall Number Z-0841-2018
Recall Event ID 79148
510(K)Number K133674  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Code Information 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 
Recalling Firm/
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Holly Wright Lee
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Under Investigation by firm
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
Quantity in Commerce 63
Distribution Domestic and Foreign
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = PHILIPS HEALTHCARE (CLEVELAND)