FDA-Device2016-12-14Class II

Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents.

Philips Medical Systems (Cleveland) Inc
Hazard

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

Sold states
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.
Affected count
20
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0706-2017

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