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 PACS software. The firm name on the label is Merge Healthcare Recalled by Merge Healthcare, Inc. Due to Studies coming over via telmed were missing patient's...

Date: January 30, 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 PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

Quantity: 109 sites have the affected versions

Why Was This Recalled?

Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.

Where Was This Sold?

Worldwide Distribution -- USA, New Zealand, and United Kingdom.

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