Class 2 Device Recall Merge Eye Station Import Utility (ESIU)

• Date Initiated by Firm: April 04, 2016
• Create Date: March 20, 2017
• Recall Status: Terminated on June 15, 2020
• Recall Number: Z-1498-2017
• Recall Event ID: 76312
• Product Classification: Medical device data system - Product Code OUG
• Product: Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
• Code Information: Versions 1.1.2 and 1.1.3
• 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: System locks up which may result in potential patient injury or delay in diagnosis or treatment.
• FDA Determined Cause: Software design
• Action: Merge Healthcare, Inc. sent an Urgent: Medical Device Recall letter dated March 28, 2016, via email on April 4, 2016. If no email address was available, the letters were issued via certified mail. Nonresponders were issued letters dated July 11, 2016, via email. The letter notifies the customer of the issue and informs them of the workaround and that a fix was not yet available, although they were working on one. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they understand the workaround. The response was required no later than April 18, 2016. Nonresponders were issued a second letter dated July 11, 2016, asking for a response by August 2, 2016. The letter and response form contained the same information as the first letter. If the second letter results in additional unresponsive customers, a call campaign will be managed by Customer Support and documented via SalesForce. Three call attempts will made before closing the case. The recalling firm reported emails will be tracked for delivery confirmation and the letters will be tracked for delivery by USPS certified services. For further questions, please call (877) 741-5369.
• Quantity in Commerce: 78 sites potentially have the affected accessory
• Distribution: Distribution was made USA (nationwide) to medical facilities. Government distribution was made. Foreign distribution was made to Canada. 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.