Class 2 Device Recall Merge Unity software

• Date Initiated by Firm: August 14, 2017
• Date Posted: August 18, 2017
• Recall Status: Terminated on May 08, 2019
• Recall Number: Z-3105-2017
• Recall Event ID: 77811
• 510(K)Number: K041935 K143318
• 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: 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; 510(K)s with Product Code = LLZ