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U.S. Department of Health and Human Services

Class 2 Device Recall Merge Healthcare CADstream

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  Class 2 Device Recall Merge Healthcare CADstream see related information
Date Initiated by Firm November 01, 2012
Create Date September 22, 2016
Recall Status1 Terminated 3 on October 05, 2020
Recall Number Z-2871-2016
Recall Event ID 75158
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 All versions - Versions 4.1.3 and prior versions
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Merge Service and Support
877-741-5369
Manufacturer Reason
for Recall		 An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.
FDA Determined
Cause 2		 Error in labeling
Action Merge sent Urgent Medical Device Recall dated January 28, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions Merge Customer Service at (877) 741-5369 or support@merge.com.
Quantity in Commerce 1,349 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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