Class II — Potential Health Hazard

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

iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended Recalled by Merge Healthcare, Inc. Due to The study is archived but cannot be opened...

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

iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data

Quantity: 298 sites potentially have the affected versions (290 of those in US)

Why Was This Recalled?

The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting in comparison studies not being available for physician review to determine the progression of disease.

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