FDA recall Z-3042-2026

Philips North America Llc · Class II · device

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.

Distribution

US and US Territories.

Key facts

Status: Ongoing
Initiation date: 2026-08-07
Report date: 2026-09-09
Voluntary/Mandated: FDA Mandated
Location: Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3042-2026