Class 2 Device Recall Merge Unity

• Date Initiated by Firm: April 08, 2016
• Date Posted: March 02, 2017
• Recall Status: Terminated 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: 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