Class 2 Device Recall Merge Eye Care PACS Viewer 5.2

• Date Initiated by Firm: June 13, 2017
• Date Posted: July 10, 2017
• Recall Status: Terminated on September 17, 2020
• Recall Number: Z-2754-2017
• Recall Event ID: 77627
• 510(K)Number: K110006
• Product Classification: System, image management, ophthalmic - Product Code NFJ
• Product: Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.
• Code Information: Version 5.2
• Recalling Firm/ Manufacturer: Merge Healthcare, Inc.; 900 Walnut Ridge Dr; Hartland WI 53029-8347
• For Additional Information Contact: recall@merge.com; 262-367-0700
• Manufacturer Reason for Recall: When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user attempts to delete an image, ECP may then read that image as OS when it is, in fact, OD.
• FDA Determined Cause: Software design
• Action: The firm initiated the recall by certified letter the week of 06/26/2017. The notice provided the work-around and requested a response.
• Quantity in Commerce: 18 units
• Distribution: FL, IL, CO, MI, CA, NY, ND, OH, CT
• 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 = NFJ