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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
Date Posted April 11, 2017
Recall Status1 Terminated 3 on February 21, 2019
Recall Number Z-1778-2017
Recall Event ID 76859
510(K)Number K082421  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Code Information Versions 9.10.0, 9.20.0, 9.20.1, 9.20.2, 9.30.3, and 9.40.0.
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		 Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
FDA Determined
Cause 2		 Software design
Action MERGE sent an Urgent Medical Device Recall letter dated April 4, 2016 to all affected customers via e-mail the week of April 4, 2016. If no email address was available, the letters were issued via certified mail. A second letter dated July 11, 2016 was issued to non-responders. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all users of the affected product be provided with the notice. Customers were also asked to reply using the enclosed form and the return addressed envelope. Customers with questions were instructed to send an email to recall@merge.com. For questions regarding this recall call 877-741-5369.
Quantity in Commerce 24 sites potentially have the affected versions
Distribution Nationwide Distribution including AZ, CA, CO, FL, GA, KS, LA, MI, MO, OH, OK, TN, TX, VA, WA, WI, and WV.
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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