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 Hemo software. Merge Hemo monitors Recalled by Merge Healthcare, Inc. Due to There is a potential connection issue when powering...

Date: March 28, 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 Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure

Quantity: 242 sites potentially have the affected versions

Why Was This Recalled?

There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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