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

Recalled September 28, 2016 · FDA recall Z-2871-2016 · Merge Healthcare

Hazard

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

Units

1,349 sites potentially have the affected versions

Sold at

US Nationwide Distribution

Description

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

Product

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.

Manufacturer(s)

Merge Healthcare, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →