Oct

2016

Merge CADstream software; Cl II

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.

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Merge CADstream software; Cl II

Amy Sellers

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