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U.S. Department of Health and Human Services

Class 2 Device Recall Merge LIS

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  Class 2 Device Recall Merge LIS see related information
Date Initiated by Firm January 23, 2017
Create Date October 23, 2020
Recall Status1 Terminated 3 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
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 2		 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.
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