IQon Spectral CT with software version 4.7.0 Product Usage: The 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. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. The IQon Spectral CT system acquires one CT dataset composed of data from a higher-energy detected x-ray spectrum and a lower-energy detected x-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
This recall has been terminated (originally issued December 16, 2016).
- Recall Initiated
- December 16, 2016
- Terminated
- July 2, 2018
- Recall Number
- Z-1006-2017
- Quantity
- 35
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results.
Distribution
Worldwide Distribution - US Nationwide in the states of AR, IN, LA, MA, MN, OR, TN & TX. and the countries: Australia, Belgium, Denmark, France, Germany, Israel, Japan, Republic of Korea, Poland, Portugal, Slovenia, Switzerland, Thailand and United Kingdom.
Lot / Code Info
System Serial Number: 860008 860009 860010 860011 860012 860013 860014 860015 860016 860017 860018 860019 860020 860021 860022 860023 860024 860027 860028 860033 860038 860039 860040 860041 860042 860043 860026 860029 860030 860031 860032 860034 860035 860036 860037
Root Cause
Software design
Action Taken
Philips sent a Customer Information Letter dated December 13, 2016 to customers via certified mail. The letter identified the affected product, problem and actions to be taken. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. For further information or support concerning this issue contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377).