Class II — Potential Health Hazard

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

ddR Formula B X-ray System Recalled by Swissray Medical Due to Potential for bucky (the part that holds the...

Date: November 18, 2016
Company: Swissray Medical
Status: Ongoing
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 Swissray Medical directly.

Affected Products

ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging

Quantity: 27 devices in US

Why Was This Recalled?

Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Swissray Medical

Swissray Medical has 2 total recalls tracked by RecallDetector.

Related Recalls

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