Class 2 Device Recall Merge Eye Care Systems

• Date Initiated by Firm: April 04, 2016
• Date Posted: March 13, 2017
• Recall Status: Terminated 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/ 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: The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
• FDA Determined Cause: 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