PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 14, 2016 Initiated: November 14, 2016 #Z-0706-2017

Product Description

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.

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

Details

Units Affected
20
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.
Location
Cleveland, OH

Frequently Asked Questions

What product was recalled?
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.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 20.
Why was this product recalled?
A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images
Which agency issued this recall?
This recall was issued by the FDA Devices on December 14, 2016. Severity: Moderate. Recall number: Z-0706-2017.