Class II — Potential Health Hazard

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

Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a Recalled by Carestream Health, Inc. Due to Carestream Health has discovered a potential safety problem...

Date: January 6, 2020
Company: Carestream Health, 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 Carestream Health, Inc. directly.

Affected Products

Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Console is the user interface. All operator functions except positioning the Bucky assembly and controls for the collimator shutter are accomplished at the operator console.

Quantity: 79

Why Was This Recalled?

Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.

Where Was This Sold?

Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.

About Carestream Health, Inc.

Carestream Health, Inc. has 17 total recalls tracked by RecallDetector.

Related Recalls

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