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.
This recall has been terminated (originally issued November 14, 2016).
- Recall Initiated
- November 14, 2016
- Terminated
- July 2, 2018
- Recall Number
- Z-0706-2017
- Quantity
- 20
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
50001 50002 50004 50005 50006 50008 50009 50100 50101 50102 50103 430000 430001 430002 430003 430004 430006 430007 430501 430502
Root Cause
Software design
Action Taken
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.