Class II — Potential Health Hazard

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

Smart CR Digital Computed Radiography System Recalled by Fujifilm Medical Systems U.S.A., Inc. Due to Reports of failure of the device's power supply.

Date: April 1, 2016
Company: Fujifilm Medical Systems U.S.A., 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 Fujifilm Medical Systems U.S.A., Inc. directly.

Affected Products

Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

Quantity: 2,062 devices

Why Was This Recalled?

Reports of failure of the device's power supply.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Fujifilm Medical Systems U.S.A., Inc.

Fujifilm Medical Systems U.S.A., Inc. has 37 total recalls tracked by RecallDetector.

Related Recalls

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