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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/
Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Merge Service and Support
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