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U.S. Department of Health and Human Services

Class 2 Device Recall Merge Eye Station and Merge Eye Care PACS

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  Class 2 Device Recall Merge Eye Station and Merge Eye Care PACS see related information
Date Initiated by Firm April 04, 2016
Create Date April 15, 2017
Recall Status1 Terminated 3 on June 22, 2020
Recall Number Z-1828-2017
Recall Event ID 76844
510(K)Number K110006  K913929  
Product Classification System, image management, ophthalmic - Product Code NFJ
Product Merge Eye Station and Merge Eye Care PACS.
Code Information All versions
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		 During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently.
FDA Determined
Cause 2		 Software in the Use Environment
Action The recalling firm issued a letter dated 3/28/2016 via email the week of 4/4/2016 or via certified mail if they did not have an email address for the customer. A second letter dated 7/11/2016 was issued to nonresponders.
Quantity in Commerce 1,627 sites potentially have the affected versions
Distribution Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as to other countries. There was also government 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 = NFJ and Original Applicant = OPHTHALMIC IMAGING SYSTEMS
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