Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Brilliance iCT Computed Tomography X-ray system Recalled by Philips Medical Systems (Cleveland) Inc Due to Perfusion scan feature may not be available on...

Date: October 29, 2015
Company: Philips Medical Systems (Cleveland) Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Medical Systems (Cleveland) Inc directly.

Affected Products

Brilliance iCT Computed Tomography X-ray system

Quantity: 51 Units

Why Was This Recalled?

Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips Medical Systems (Cleveland) Inc

Philips Medical Systems (Cleveland) Inc has 313 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report