Class II — Potential Health Hazard

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

Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional Recalled by Philips Medical Systems (Cleveland) Inc Due to The firm discovered Ring/Dot artifact due to X-ray...

Date: September 14, 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

Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Quantity: 36 units

Why Was This Recalled?

The firm discovered Ring/Dot artifact due to X-ray measurement error.

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