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. Radiological image processing system. Recalled by Merge Healthcare, Inc. Due to When RadSuite is used with IPID (Issuer of...

Date: April 9, 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. Radiological image processing system.

Quantity: 10 sites have the affected software that is configured with the specific conditions listed in Code Information

Why Was This Recalled?

When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient.

Where Was This Sold?

This product was distributed to 6 states: AL, MI, MO, PA, TN, TX

Affected (6 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