Class 2 Device Recall Merge LIS software

• Date Initiated by Firm: March 05, 2015
• Create Date: November 11, 2016
• Recall Status: Terminated on April 12, 2019
• Recall Number: Z-0399-2017
• Recall Event ID: 75419
• Product Classification: Calculator/data processing module, for clinical use - Product Code JQP
• Product: Merge LIS software.
• Code Information: Versions: 4.0.1 and earlier.
• FEI Number: 1000116130
• Recalling Firm/ Manufacturer: Merge Healthcare, Inc.; 900 Walnut Ridge Dr; Hartland WI 53029-8347
• For Additional Information Contact: Merge Service & Support; 877-741-5369
• Manufacturer Reason for Recall: There is a potential for duplicate container numbers to be created for patients.
• FDA Determined Cause: Software design
• Action: The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/30/2016. If no email address was available, the letters were issued via certified mail. Letters to nonresponders were issued 5/26/2016.
• Quantity in Commerce: 413 sites potentially have the affected software
• Distribution: Distribution was made nationwide and to the Virgin Islands. Foreign distribution was made to the Bahamas.
• 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.