IQon Spectral CT with 4 — Class II medical device recall Z-0841-2018
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2018-03-14. 23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Softw
| Recall number | Z-0841-2018 |
|---|---|
| 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 | 2018-01-11 |
| Classified | 2018-03-02 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2019-05-20 |
| Quantity | 63 |
| Reason classes | software |
| Serial numbers | 860008, 860009, 860010, 860011, 860012, 860013, 860014, 860015, 860016, 860017, 860018, 860019, 860020, 860021, 860022, 860023, 860024, 860025, 860026, 860027, 860028, 860029, 860030, 860031, 860032 and 38 more |
| Model numbers | 728332 |
Product
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Reason for recall
23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT 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-0841-2018. 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.