Class II — Philips North America Llc
| Recalling firm | Philips North America Llc |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| 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 |
| Quantity | N/A |
| Distribution | US and US Territories. |
| Initiated | 2026-08-07 |
| Classified | 2026-09-01 |
| Recall number | Z-3042-2026 |
| Initiation | FDA Mandated |
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 North America Llc (Z-3042-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99784/
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