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U.S. Department of Health and Human Services

Class 2 Device Recall Merge Unity software

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  Class 2 Device Recall Merge Unity software see related information
Date Initiated by Firm August 14, 2017
Date Posted August 18, 2017
Recall Status1 Terminated 3 on May 08, 2019
Recall Number Z-3105-2017
Recall Event ID 77811
510(K)Number K143318  K041935  
Product Classification System, image processing, radiological - Product Code LLZ
Product Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Unity 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 Software versions 10.0, 10.0.1, 10.0.2, 10.0.3, 10.0.4, 10.0.5, 11.0, 11.0.1, 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1, 11.1.1.1, 11.1.1 Patch 2, 11.1.1 Patch 3, 11.1.2, 11.1.2 Patch 1, 11.1.2 Patch 2, 11.1.2 Patch 3, and 11.1.2 Patch 4.  Only customers with one of the above listed software versions AND a license for Mammo Tracking are impacted by this recall.  
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Margaret Mucha
262-912-3514
Manufacturer Reason
for Recall		 The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
FDA Determined
Cause 2		 Process design
Action MERGE sent a Medical Device Recall letter dated August 11, 2017, to all affected customers. Customers were advised to discontinue using the affected product and to reply using the enclosed form. Customers with questions were instructed to send an email to recall@merge.com. For questions regarding this recall call 262-912-3514.
Quantity in Commerce 98 sites have the potentially affected software
Distribution 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 = DR Systems, Inc
510(K)s with Product Code = LLZ and Original Applicant = DR. SYSTEMS, INC.
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