Class II — Potential Health Hazard

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

Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Recalled by Philips Medical Systems (Cleveland) Inc Due to 5 issues. Fast Get Ready incorrectly enabled during...

Date: February 5, 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

Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Quantity: 4 Units

Why Was This Recalled?

5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. DoseRight incorrectly enabled when the Exam Card specified disabling DoseRight. Tube heat predict

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.

Related Recalls

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