Z-0705-2017Class II

IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body...

Name: Z-0705-2017 IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2016-11-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-11-14 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of 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... on 2016-11-14. FDA classified it as Class II and gives the reason as "A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images". 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-0705-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-14
Posted: 2018-07-02
Terminated: 2018-07-02
Recalling firm: Philips North America LLC
Product: 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.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images
Root cause tag: software
FDA root cause: Software design
Action: A Field Safety Notice (Attachment #1 Field Safety Notice FSN 16-061-72800659 and FSN 88100051), will be sent to US consignees via certified mail. Philips Key Market representatives will distribute the notice internationally, based on local regulations. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.
Quantity in commerce: 24
Distribution: Software was distributed in the following states: AR, IN, LA, MA, MN, OR and TN. Softward was also shipped to the following countries: Belgium, Denmark, France, Germany, Japan, Korea, Switzerland and United Kingdom.
Product codes and lots: 860008 860009 860010 860011 860012 860013 860014 860015 860016 860017 860018 860019 860020 860021 860022 860023 860024 860028 860026 860029 860030 860031 860034 860035

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0705-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0705-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-03
Z-0706-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-03

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)