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 DuraDiagnost X- Ray Recalled by Philips Medical Systems, Inc. Due to The system is designed to emit a beep...

Date: February 9, 2015
Company: Philips Medical Systems, 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, Inc. directly.

Affected Products

Philips Healthcare DuraDiagnost X- Ray

Quantity: 3 DuraDiagnost

Why Was This Recalled?

The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j).

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips Medical Systems, Inc.

Philips Medical Systems, Inc. has 65 total recalls tracked by RecallDetector.

Related Recalls

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