Cl II Merge CADstream software

Company: Merge Healthcare, Inc.
Date of Enforcement Report 9/28/2016
Class lI:

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.
Recall Number Z-2871-2016

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

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 9/22/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1349 sites

DISTRIBUTION
Nationwide

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.