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

Recall date

November 1, 2012

Source

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

Recall number

Z-2871-2016

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

US Nationwide Distribution

Why it was recalled

An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.

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.