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 Cardio software using EchoIMS. The firm name on the Recalled by Merge Healthcare, Inc. Due to A situation can occur allowing two physicians to...

Date: April 4, 2016
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 Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.

Quantity: 17 sites potentially have the affected versions

Why Was This Recalled?

A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.

Where Was This Sold?

This product was distributed to 10 states: CA, FL, IL, MD, MO, OH, OK, TX, VT, WI

Affected (10 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