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

Recalled October 26, 2016 · FDA recall Z-0118-2017 · Merge Healthcare

Hazard

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

Units

844 sites potentially have the affected versions

Sold at

US Nationwide Distribution

Description

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

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 →