IQon Spectral CT is a Computed Tomography X-Ray System intended to… — Class II medical device recall Z-0705-2017
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2016-12-14, distributed in AR, IN, LA, MA, MN, OR, TN. A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filmi
| Recall number | Z-0705-2017 |
|---|---|
| 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 | 2016-11-14 |
| Classified | 2016-12-03 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2018-07-02 |
| Distributed | AR, IN, LA, MA, MN, OR, TN |
| Countries outside the US | BE, CH, DE, DK, FR, GB, JP, KR |
| Quantity | 24 |
| Reason classes | software |
Product
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.
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
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-0705-2017. 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.