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U.S. Department of Health and Human Services

Class 2 Device Recall Merge Eye Care Systems

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  Class 2 Device Recall Merge Eye Care Systems see related information
Date Initiated by Firm April 04, 2016
Date Posted March 13, 2017
Recall Status1 Terminated 3 on June 22, 2020
Recall Number Z-1681-2017
Recall Event ID 76309
510(K)Number K110006  K913929  
Product Classification System, image management, ophthalmic - Product Code NFJ
Product Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Code Information All versions of Eye Care PACS, Eye Station, and ESIU.
Recalling Firm/
Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Merge Service and Support
Manufacturer Reason
for Recall
The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
FDA Determined
Cause 2
Software Design Change
Action The recalling firm issued a letter dated 3/28/2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail.
Quantity in Commerce 1,627 sites potentially have the affected software
Distribution Distribution was made to medical facilities nationwide. Government distribution was made. Foreign distribution was made to Canada, as well as other countries. There was no military 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