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U.S. Department of Health and Human Services

Class 2 Device Recall Merge Eye Care PACS Viewer 5.2

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  Class 2 Device Recall Merge Eye Care PACS Viewer 5.2 see related information
Date Initiated by Firm June 13, 2017
Date Posted July 10, 2017
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = OPHTHALMIC IMAGING SYSTEMS
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