Merge Healthcare, Inc. recalls CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, anal…

Recall date

October 19, 2011

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0118-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

US Nationwide Distribution

Why it was recalled

Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.