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 DIRECTVIEW CR Software Generates digital mammographic images that can Recalled by Carestream Health, Inc. Due to Reduced mammographic image quality when attempting to print...

Date: October 30, 2014
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 DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.

Quantity: 59 units

Why Was This Recalled?

Reduced mammographic image quality when attempting to print true size multi-format images

Where Was This Sold?

This product was distributed to 3 states: NY, NC, OH

Affected (3 states)Not affected

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