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U.S. Department of Health and Human Services

Class 2 Device Recall Merge PACS (Picture Archiving Communication System) software

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  Class 2 Device Recall Merge PACS (Picture Archiving Communication System) software see related information
Date Initiated by Firm April 04, 2016
Create Date February 09, 2017
Recall Status1 Terminated 3 on April 08, 2019
Recall Number Z-1176-2017
Recall Event ID 76260
510(K)Number K082144  
Product Classification System, image processing, radiological - Product Code LLZ
Product Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Code Information Version 7.0.1
Recalling Firm/
Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Merge Service and Support
Manufacturer Reason
for Recall
Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.
FDA Determined
Cause 2
Software design
Action The recalling firm issued a letter dated 3/28/2016 via email on 4/4/2016 or via certified mail if they did not have an email address for the customer. A second letter was issued 7/11/2016 to nonresponders.
Quantity in Commerce 29 sites have the potentially affected software
Distribution Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/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 = LLZ and Original Applicant = AMICAS, INC.