RecallRadar

FDA Device recall Z-0705-2017

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

On 2016-12-14 the FDA classified a Class II 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… by Philips Medical Systems Cleveland, citing A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0705-2017
ClassificationClass II
Statusterminated
Initiated2016-11-14
Published2016-12-14
Last updated2026-09-13 11:54 UTC
CompanyPhilips Medical Systems Cleveland
DistributionAR, IN, LA, MA, MN, OR, TN

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.

Reason

A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images

Identifiers

code_info
860008 860009 860010 860011 860012 860013 860014 860015 860016 860017 860018 860019 860020 860021 860022 8…860008 860009 860010 860011 860012 860013 860014 860015 860016 860017 860018 860019 860020 860021 860022 860023 860024 860028 860026 860029 860030 860031 860034 860035

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0705-2017%22

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