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U.S. Department of Health and Human Services

Class 2 Device Recall Merge OrthoPACS

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  Class 2 Device Recall Merge OrthoPACS see related information
Date Initiated by Firm July 11, 2019
Create Date July 23, 2019
Recall Status1 Terminated 3 on March 17, 2023
Recall Number Z-2063-2019
Recall Event ID 83300
510(K)Number K173475  
Product Classification System, image processing, radiological - Product Code LLZ
Product Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Code Information Version 7.3 (UDI Number (01)00842000100706(10)7.3.0.158618(11)180409); 7.3.1 (UDI Number (01)00842000100706(10)7.3.1.161404(11)180830); 8.0 (UDI Number (01)00842000100775(10)8.0.0.162051(11)181026); 8.0.1 (UDI Number (01)00842000100775(10)8.0.1.165704(11)190528)
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact
262-367-0700
Manufacturer Reason
for Recall		 Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
FDA Determined
Cause 2		 Software Design Change
Action Merge Healthcare notified customers on about 07/11/2019 via "Urgent Field Safety Notice" letter. The notice informed customers of two possible issues that may occur on Merge PACS and Merge OrthoPACS: 1. Prior thumbnails may not display in reverse chronological order. 2. Images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Use of an out of order image may result in the implementation of an incorrect or unnecessary treatment plan such as unnecessary medication, change in dosage of existing medication, or unnecessary medical procedures. It may also lead to progression of an existing patient condition, which may result in the progression of a disease state. Merge Healthcare will provide a software correction for the issue. A Merge Healthcare representative will contact each customer schedule the correction. In the interim, Merge Healthcare instructed customers that they can continue to use their Merge PACS/OrthoPACS devices by following the below instructions: 1. When pulling a series from thumbnail bar, confirm that the date of each series is visible in the viewport. The date will appear when overlays are configured to display the date. An administrator can assist in configuring Merge PACS/OrthoPACS if needed. 2. When utilizing the mammography scroll stacking tool, confirm that the date of each series is visible in the viewport. The date will appear when overlays are configured to display the date. An administrator can assist in configuring Merge PACS/OrthoPACS if needed. Customers were instructed to use the date, rather than the order the series are presented in, to determine chronological order. Additional instructions included to ensure all potential users of Merge PACS and Merge OrthoPACS have received this notice. Questions regarding the recall notice can be directed to Merge Customer Support at 877-741-5369.
Quantity in Commerce 73 devices
Distribution Nationwide distribution to Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Wisconsin. International distribution to Belgium and Canada.
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 = Merge Healthcare Incorporated
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