Class II — Philips Medical Systems (Cleveland) Inc
| Recalling firm | Philips Medical Systems International BV |
|---|---|
| Registered facility | View this company's 54 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results. |
| 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 … |
| Quantity | 35 |
| 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. |
| Initiated | 2016-12-16 |
| Classified | 2017-01-11 |
| Terminated | 2018-07-02 |
| Recall number | Z-1006-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Philips Medical Systems (Cleveland) Inc (Z-1006-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76024/
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