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 DuraDiagnost stationary X-ray system Recalled by Philips Electronics North America Corporation Due to Buttons or keys on the monitor allow the...

Date: September 17, 2015
Company: Philips Electronics North America Corporation
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 Electronics North America Corporation directly.

Affected Products

Philips DuraDiagnost stationary X-ray system

Quantity: 15

Why Was This Recalled?

Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].

Where Was This Sold?

This product was distributed to 8 states: CA, ME, NE, NC, OH, OR, TX, WA

Affected (8 states)Not affected

About Philips Electronics North America Corporation

Philips Electronics North America Corporation has 160 total recalls tracked by RecallDetector.

Related Recalls

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