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 16 Slice (Air) Recalled by Philips Medical Systems (Cleveland) Inc Due to There is a potential for separation of fiberglass...

Date: October 18, 2018
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 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories

Quantity: 6,343 units in total

Why Was This Recalled?

There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall

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