FDA recall Z-3041-2026

Product

Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.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-3041-2026