FDA recall Z-3040-2026

Product

Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.

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-3040-2026