Z-1006-2017Class II

IQon Spectral CT with software version 4.7.0

Name: Z-1006-2017 IQon Spectral CT with software version 4.7.0
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2016-12-16
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-12-16 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional... on 2016-12-16. FDA classified it as Class II and gives the reason as "Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results". 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-1006-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-16
Posted: 2017-01-11
Terminated: 2018-07-02
Recalling firm: Philips North America LLC
Product: IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. The IQon Spectral CT system acquires one CT dataset composed of data from a higher-energy detected x-ray spectrum and a lower-energy detected x-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results.
Root cause tag: software
FDA root cause: Software design
Action: Philips sent a Customer Information Letter dated December 13, 2016 to customers via certified mail. The letter identified the affected product, problem and actions to be taken. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. For further information or support concerning this issue contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in commerce: 35
Distribution: Worldwide Distribution - US Nationwide in the states of AR, IN, LA, MA, MN, OR, TN & TX. and the countries: Australia, Belgium, Denmark, France, Germany, Israel, Japan, Republic of Korea, Poland, Portugal, Slovenia, Switzerland, Thailand and United Kingdom.
Product codes and lots: System Serial Number: 860008 860009 860010 860011 860012 860013 860014 860015 860016 860017 860018 860019 860020 860021 860022 860023 860024 860027 860028 860033 860038 860039 860040 860041 860042 860043 860026 860029 860030 860031 860032 860034 860035 860036 860037

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1006-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1006-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-11

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)