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U.S. Department of Health and Human Services

Class 2 Device Recall Merge Unity

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  Class 2 Device Recall Merge Unity see related information
Date Initiated by Firm April 08, 2016
Date Posted March 02, 2017
Recall Status1 Terminated 3 on March 06, 2017
Recall Number Z-1385-2017
Recall Event ID 76471
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.

Product Usage:
Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
Code Information Versions 11.0 and 11.0.1
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 is not adding the correct tomo image.
FDA Determined
Cause 2		 Software design
Action Merge sent an Urgent Medical Device Recall dated July 11, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions send an email to recall@merge.com
Quantity in Commerce 28 sites potentially have the affected software
Distribution US Nationwide Distribution in the states of AL CA, CO, FL, IL, MD, MN, MT, NV, NY, OR, PA SC, TN, 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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