Recall Z-3042-2026— Philips North America Llc

Name: FDA recall Z-3042-2026
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: K160743. 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: 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

K160743 — Philips Ingenuity CTPhilips Medical Systems (Cleveland), Inc.·cleared 2016-08-08

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 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.

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