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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 April 04, 2016
Create Date March 14, 2017
Recall Status1 Terminated 3 on August 05, 2019
Recall Number Z-1457-2017
Recall Event ID 76447
510(K)Number K082421  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Merge Hemo software.

Product Usage:
Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
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
877-741-5369
Manufacturer Reason
for Recall		 In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation.
FDA Determined
Cause 2		 Software design
Action The recalling firm issued a letter dated March 28, 2016 via e-mail. If no email address was available, the letters were issued via certified mail. Non-responders were issued letters on July 11, 2016. The letter identified the affected product, problem and actions to be taken. For question send an email to recall@merge.com.
Quantity in Commerce 361 sites potentially have the affected versions
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 = DQK and Original Applicant = EMAGEON INC.
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