Class II — Potential Health Hazard

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

Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body Recalled by Philips Healthcare Inc. Due to Philips Healthcare discovered the customer was performing CTDI...

Date: April 5, 2010
Company: Philips Healthcare 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 Healthcare Inc. directly.

Affected Products

Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into cross-sectional images. Each device also includes signal analysis and display equipment, patient and equipment supports, components, and accessories.

Quantity: 2089 US 4036 ROW

Why Was This Recalled?

Philips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and received results that were 15 to 25% higher than Philips protocol parameters stated.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips Healthcare Inc.

Philips Healthcare Inc. has 36 total recalls tracked by RecallDetector.

Related Recalls

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