IQon Spectral CT with software version 4 — Class II medical device recall Z-1006-2017
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2017-01-18, distributed nationwide. Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation
| Recall number | Z-1006-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2016-12-16 |
| Classified | 2017-01-11 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2018-07-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CH, DE, DK, FR, GB, IL, JP, KR, PL, PT, SI, TH |
| Quantity | 35 |
| Serial numbers | 860008, 860009, 860010, 860011, 860012, 860013, 860014, 860015, 860016, 860017, 860018, 860019, 860020, 860021, 860022, 860023, 860024, 860026, 860027, 860028, 860029, 860030, 860031, 860032, 860033 and 10 more |
Product
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.
Reason for recall
Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1006-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.