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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