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Open, Classified

Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x

FDA Recall Z-3041-2026 · Posted 2026-09-01

Recalling FirmPhilips North America Llc
Recall StatusOpen, Classified
Product CodeJAK
Date Initiated2026-08-07

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.

Firm Action

Philips will inform customers of the issue via an Electronic Product Radiation Correction notification, dated "AUG 2026". Philips will schedule an appointment with remaining customers to update the software free of charge. Customers who need additional information or support concerning this issue should be directed to their local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center). Philips reference: 2025-PD-CTAMI-014.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US and US Territories.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K193454IQon Spectral CTPhilips Medical Systems Nederland B.V. · 2020-01-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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