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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 softwaresee related information
Date Initiated by FirmAugust 07, 2017
Create DateOctober 11, 2018
Recall Status1 Terminated 3 on May 18, 2020
Recall NumberZ-2566-2018
Recall Event ID 80570
510(K)NumberK041935 K143318 
Product Classification System, image processing, radiological - Product Code LLZ
ProductMerge 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 10.0.6 and 10.0.7. Only customers with these 2 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
262-367-0700
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
ActionMERGE sent a Medical Device Recall letter on about 08/07/2017, 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 Commerce11 sites have potentially affected software
DistributionNationwide distribution to CA, KY, ME, OH, OR, TN, TX, WA, WV.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
510(K)s with Product Code = LLZ
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