Class II — Potential Health Hazard

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

Merge RadSuite software. The firm name on the label is Merge Healthcare Recalled by Merge Healthcare, Inc. Due to The values provided from the Pixel Value tool...

Date: November 17, 2015
Company: Merge Healthcare, 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 Merge Healthcare, Inc. directly.

Affected Products

Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.

Quantity: 8 sites have the potentially affected version

Why Was This Recalled?

The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.

Where Was This Sold?

This product was distributed to 5 states: AL, IN, MI, PA, WI

Affected (5 states)Not affected

About Merge Healthcare, Inc.

Merge Healthcare, Inc. has 93 total recalls tracked by RecallDetector.

Related Recalls

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