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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 July 02, 2012
Date Posted August 04, 2016
Recall Status1 Terminated 3 on June 26, 2017
Recall Number Z-2341-2016
Recall Event ID 74577
510(K)Number K082421  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Merge HEMO software.
Code Information Software versions 8.10, 9.10, 9.20.
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact
262-367-0700
Manufacturer Reason
for Recall		 The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7
FDA Determined
Cause 2		 Software design
Action The firm issued an "Important Product Information" bulletin to customers dated 7/2/2012 via e-mail letting them know there was an upgrade available. On 1/30/2016, the recalling firm initiated phone calls to their customers letting them know there was an upgrade available and if they declined it, they would like a written response.
Quantity in Commerce 37
Distribution The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign 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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