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Class 2 Device Recall Merge Unity software |
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Date Initiated by Firm |
August 07, 2017 |
Create Date |
October 11, 2018 |
Recall Status1 |
Terminated 3 on May 18, 2020 |
Recall Number |
Z-2566-2018 |
Recall Event ID |
80570 |
510(K)Number |
K041935 K143318
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Product Classification |
System, image processing, radiological - Product Code LLZ
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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 10.0.6 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
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For Additional Information Contact |
262-367-0700
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Manufacturer Reason for Recall |
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
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FDA Determined Cause 2 |
Process design |
Action |
MERGE 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 Commerce |
11 sites have potentially affected software |
Distribution |
Nationwide distribution to CA, KY, ME, OH, OR, TN, TX, WA, WV. |
Total Product Life Cycle |
TPLC Device Report
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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.
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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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