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 Recalled by Philips Medical Systems (Cleveland) Inc Due to During a retrospective review of production documentation it...

Date: December 23, 2016
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

Quantity: 1-unit

Why Was This Recalled?

During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.

Where Was This Sold?

Product was not distributed in the US. Unit was distributed in Australia.

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