Z-0841-2018Class II

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

Name: Z-0841-2018 IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2018-01-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-01-11 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System on 2018-01-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0841-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-11
Posted: 2018-03-02
Terminated: 2019-05-20
Recalling firm: Philips North America LLC
Product: IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: software
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0841-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0841-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-02

Product code JAK

K133674Class IIPhilips Iqon Spectral CTPhilips Healthcare (Cleveland) / cleared 2014-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)