Company: Merge Healthcare, Inc.
Date of Enforcement Report 9/14/2016
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-0118-2017
REASON
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/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 10/18/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
844 sites potentially have the affected versions
DISTRIBUTION
Nationwide.
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