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U.S. Department of Health and Human Services

Class 2 Device Recall OLS Symphony. DFC1024 & DFC512 DIGITAL IMAGING SYSTEM

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  Class 2 Device Recall OLS Symphony. DFC1024 & DFC512 DIGITAL IMAGING SYSTEM see related information
Date Initiated by Firm March 28, 2016
Create Date February 23, 2017
Recall Status1 Terminated 3 on April 17, 2020
Recall Number Z-1246-2017
Recall Event ID 75914
510(K)Number K110006  K913929  
Product Classification System, image management, ophthalmic - Product Code NFJ
Product Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Code Information Merge ESIU: Versions 1.0, 1.1.1, 1.1.2, and 1.1.3; Merge Eye Station: All versions; Merge Eye Care PACS: Versions 4.1, 4.2, 4.3, 5.0, and 5.1 
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		 Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)
FDA Determined
Cause 2		 Device Design
Action The recalling firm issued a letter dated 3/28/2016 via e-mail. If no email address was available, the letters were issued via certified mail. A follow-up letter dated 7/11/2016 was also issued.
Quantity in Commerce 1,627 sites potentially have the affected versions
Distribution Distribution was nationwide to medical facilities. There was also government and foreign distribution, including Canada.
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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