Philips Ingenuity Core 128 computed tomography x-ray system — Class II medical device recall Z-0520-2018
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2018-02-14. Numerous issues related to software Brilliance iCT 4.1.6 software version.
| Recall number | Z-0520-2018 |
|---|---|
| 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 | 2017-10-06 |
| Classified | 2018-02-04 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2019-07-02 |
| Reason classes | software |
Product
Philips Ingenuity Core 128 computed tomography x-ray system
Reason for recall
Numerous issues related to software Brilliance iCT 4.1.6 software version.
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-0520-2018. 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.