Class II — Potential Health Hazard

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

Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is Recalled by Shimadzu Medical Systems Due to The firm is recalling the Shimadzu Mobile X-ray...

Date: November 10, 2015
Company: Shimadzu Medical Systems
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 Shimadzu Medical Systems directly.

Affected Products

Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.

Quantity: 297 units

Why Was This Recalled?

The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly.

Where Was This Sold?

US Distribution and Internationally to Canada

About Shimadzu Medical Systems

Shimadzu Medical Systems has 25 total recalls tracked by RecallDetector.

Related Recalls

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