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U.S. Department of Health and Human Services

Class 2 Device Recall Merge Hemo software

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  Class 2 Device Recall Merge Hemo software see related information
Date Initiated by Firm March 28, 2016
Create Date January 24, 2017
Recall Status1 Terminated 3 on June 28, 2019
Recall Number Z-1091-2017
Recall Event ID 76214
510(K)Number K082421  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Code Information Versions 6.10, 6.10.1, 6.10.2, 6.10.3, 7.10, 7.20, 7.20.1, 8.10.0, 8.20, 9.10.0, 9.20, 9.20.2, 9.20.3, 9.30, 9.40, 9.40.1, 9.40.2, and 9.40.3
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Merge Service and Support
262-367-0700
Manufacturer Reason
for Recall		 There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.
FDA Determined
Cause 2		 Software design
Action MERGE sent an Urgent Medical Device Recall letter dated July 11, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to reply using the enclosed form and ensure all users of the product are provided with the notification. Customers with questions were instructed to send an email to recall@merge.com..
Quantity in Commerce 242 sites potentially have the affected versions
Distribution 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 = DQK and Original Applicant = EMAGEON INC.
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