Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327 — Class II medical device recall Z-3042-2026
Ongoing recall by Philips North America Llc, reported 2026-09-09. Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT
| Recall number | Z-3042-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2026-08-07 |
| Classified | 2026-09-01 |
| Reported by FDA | 2026-09-09 |
| UPC / GTIN / UDI-DI | 00884838059863, 00884838098701 |
Product
Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
Reason for recall
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
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-3042-2026. 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.