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U.S. Department of Health and Human Services

Class 2 Device Recall Merge Cardio

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 Class 2 Device Recall Merge Cardiosee related information
Date Initiated by FirmJanuary 30, 2016
Create DateSeptember 21, 2016
Recall Status1 Terminated 3 on December 15, 2017
Recall NumberZ-2865-2016
Recall Event ID 75034
510(K)NumberK051649 
Product Classification System, image processing, radiological - Product Code LLZ
ProductMerge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
Code Information Version 10.1
FEI Number 1000116130
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		Patient information in the header is only found on the first page of the report and not on the subsequent pages.
FDA Determined
Cause 2		Software design
ActionMerge sent an Urgent Medical Device Recall letter dated January 28, 2016 to affected customers via e-mail or via certified mail if they did not have an e-mail address. The letter identified the affected product, problem and actions to be taken. For questions call Merge Customer Service at (877)741-5369 or support@merge.com.
Quantity in Commerce42 sites potentially have the affected version
DistributionUS Nationwide 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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