Recall Z-3041-2026— Philips North America Llc

Name: FDA recall Z-3041-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-07

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2026-08-07. It names one FDA 510(k) clearance: K193454. Product: Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x. 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..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2026-08-07
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K193454 — IQon Spectral CTPhilips Medical Systems Nederland B.V.·cleared 2020-01-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.