CADstream software Product Usage: CADstream is an image processing system designed to assis...
FDA Recall #Z-0118-2017 — Class II — October 19, 2011
Product Description
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.
Reason for Recall
Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.
Recalling Firm
Merge Healthcare, Inc. — Hartland, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
844 sites potentially have the affected versions
Distribution
US Nationwide Distribution
Code Information
Versions prior to 5.2.6
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated