Recall Weekly
Moderate riskFDA DeviceClass II

Philips Brilliance iCT CT scanner recalled for unintended radiation issue

Philips has identified an unintended radiation issue affecting Philips Brilliance iCT, Brilliance iCT Upgrades, and Brilliance iCT SP CT scanner systems running software version 4.1.10.x. This issue could affect the performance and safety of the equipment.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

  1. If your facility operates one of these Philips CT models, contact Philips North America immediately for guidance on remediation.
  2. Do not operate affected equipment until you have received and implemented Philips' corrective instructions.
  3. Consult the FDA MedWatch alert and your equipment documentation for detailed product codes and UDI numbers.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
Sold in
Nationwide
Made for
All ages

This recall covers 4 products — see all of them.

Details

Units affected
N/A
Illnesses reported
None reported
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Classification
Class II
Recall number
Z-3040-2026

In the FDA's words

Description
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311. 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. UDI for Brilliance iCT: (01)00884838059474, UDI for Brilliance iCT Upgrades: N/A, UDI for Brilliance iCT SP: N/A. Distribution: US and US Territories. Affected quantity: N/A
Hazard
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.

4 products in this recall

Philips IQon, iCT, Ingenuity and Brilliance CT systems recalled for radiation issue

Philips is recalling four CT scanner product lines, covering 4 product groups, because an unintended radiation issue could affect how the equipment performs. The recall covers Philips Brilliance, IQon Spectral CT, Ingenuity CT, and Brilliance CT 64 systems distributed in the US and US territories. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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