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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 Cardio see related information
Date Initiated by Firm January 30, 2016
Create Date September 21, 2016
Recall Status1 Terminated 3 on December 15, 2017
Recall Number Z-2865-2016
Recall Event ID 75034
510(K)Number K051649  
Product Classification System, image processing, radiological - Product Code LLZ
Product Merge 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
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Merge 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
Action Merge 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 Commerce 42 sites potentially have the affected version
Distribution US Nationwide 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 = CAMTRONICS MEDICAL SYSTEMS
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