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U.S. Department of Health and Human Services

Class 2 Device Recall CADstream software

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  Class 2 Device Recall CADstream software see related information
Date Initiated by Firm October 19, 2011
Create Date October 18, 2016
Recall Status1 Terminated 3 on September 18, 2020
Recall Number Z-0118-2017
Recall Event ID 75161
510(K)Number K092954  
Product Classification System, image processing, radiological - Product Code LLZ
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.
Code Information Versions prior to 5.2.6
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Carol Nakagawa
800-724-5970 Ext. 8027
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action Merge sent an Urgent Medical Device Recall dated January 28, 2016 to affected customers via email and certified mail if no email address was available. The letter identified the affected product, problem and actions to be taken. For questions Customer Service at 877-741-5369 or support@merge.com.
Quantity in Commerce 844 sites potentially have the affected versions
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = CONFIRMA, INC.
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