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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) softwaresee related information
Date Initiated by FirmApril 04, 2016
Create DateFebruary 09, 2017
Recall Status1 Terminated 3 on April 08, 2019
Recall NumberZ-1176-2017
Recall Event ID 76260
510(K)NumberK082144 
Product Classification System, image processing, radiological - Product Code LLZ
ProductMerge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Code Information Version 7.0.1
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information ContactMerge Service and Support
877-741-5369
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
ActionThe 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 Commerce29 sites have the potentially affected software
DistributionDistribution 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 CycleTPLC 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) Database510(K)s with Product Code = LLZ
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