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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