FDAOctober 19, 2011device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

merge healthcaremerge

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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