Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2017 - (Recall #: Z-1006-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 16, 2016

Date Posted: January 18, 2017

Recall Number: Z-1006-2017

Event ID: 76024

Reason for Recall:

Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results.

Status: Terminated

Product Quantity: 35

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated