Class 2 Device Recall Merge LIS

• Date Initiated by Firm: January 23, 2017
• Create Date: October 23, 2020
• Recall Status: Terminated on May 01, 2021
• Recall Number: Z-0289-2021
• Recall Event ID: 86449
• Product Classification: Software, transmission and storage, patient data - Product Code NSX
• Product: Merge LIS
• Code Information: Merge LIS versions 4.0.1, 4.1, 4.1.1, 4.1.2, 4.1.3, 4.1.4, 4.1.5, 4.1.5 Patch 1, and 4.1.5 Patch 2
• FEI Number: 1000116130
• Recalling Firm/ Manufacturer: Merge Healthcare, Inc.; 900 Walnut Ridge Dr; Hartland WI 53029-8347
• For Additional Information Contact: Mr. Todd Brill; 617-528-1732
• Manufacturer Reason for Recall: A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.
• FDA Determined Cause: Software design
• Action: A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.
• Quantity in Commerce: 47 units
• Distribution: Domestic Distribution Only: Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Oklahoma, Tennessee, Texas.

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.