Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-0706-2017

November 14, 2016

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 75755
Status
Terminated
Classification
Class II
Quantity
20
Official record key
device-enforcement:Z-0706-2017

Official wording

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

Code information: 50001 50002 50004 50005 50006 50008 50009 50100 50101 50102 50103 430000 430001 430002 430003 430004 430006 430007 430501 430502

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software defect