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U.S. Department of Health and Human Services

Class 2 Device Recall DR Systems Unity PACS software, now known as Merge Unity PACS software.

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  Class 2 Device Recall DR Systems Unity PACS software, now known as Merge Unity PACS software. see related information
Date Initiated by Firm October 15, 2015
Create Date December 30, 2016
Recall Status1 Terminated 3 on April 23, 2021
Recall Number Z-0939-2017
Recall Event ID 75876
510(K)Number K041935  
Product Classification System, image processing, radiological - Product Code LLZ
Product DR Systems Unity PACS software, now known as Merge Unity PACS software.
Code Information Version 11.0
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 fails to associate to the correct MG image if there are two images for the same view.
FDA Determined
Cause 2		 Software design
Action Merge sent an Urgent : Medical Device Recall letter dated July 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Be aware of the following workaround: Customer I User: Ensure both" tome" images are reviewed when more than one is captured for the same view. Merge has a released fix available for this issue. YOUR RESPONSE TO THIS NOTIFICATION IS REQUIRED Please reply using the enclosed form and the return addressed envelope. Your response is required no later than August 2,2016. For further questions regarding this recall please call (877) 741-5369
Quantity in Commerce 9 sites potentially have the effected software
Distribution Distribution was made to medical facilities located in MT, CA, PA, and TX.
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 = DR. SYSTEMS, INC.
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