Class II — Potential Health Hazard

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

CARESTREAM DRX -Mobile Retrofit Kit Recalled by Carestream Health Inc. Due to Carestream Health Inc. has conducted a voluntary field...

Date: August 29, 2013
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

CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients

Quantity: 364 units

Why Was This Recalled?

Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Carestream Health Inc.

Carestream Health Inc. has 61 total recalls tracked by RecallDetector.

Related Recalls

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