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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 January 30, 2016
Create Date October 19, 2016
Recall Status1 Open3, Classified
Recall Number Z-0137-2017
Recall Event ID 75239
510(K)Number K092954  
Product Classification System, image processing, radiological - Product Code LLZ
Product CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
Code Information Versions prior to 5.2.9
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
The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up.
FDA Determined
Cause 2
Software design
Action Merge Healthcare Inc. sent an Urgent Medical Device Recall letter dated January 28, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. In addition, the customer is requested to call Customer Service or send them an email to schedule the upgrade. If the customer chooses not to upgrade, they are requested to complete the attached form or go online and complete it. Merge Healthcare is committed to improve efficiencies and enhancing the quality of healthcare worldwide.If you have any additional questions, call Merge Customer Service at (877) 741-5369 or support@merge.com.
Quantity in Commerce 844 sites potentially have the affected versions
Distribution Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = CONFIRMA, INC.
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