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U.S. Department of Health and Human Services

Class 2 Device Recall Merge Hemo with software versions 10.0 LA

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  Class 2 Device Recall Merge Hemo with software versions 10.0 LA see related information
Date Initiated by Firm October 26, 2015
Create Date December 28, 2015
Recall Status1 Terminated 3 on July 22, 2016
Recall Number Z-0554-2016
Recall Event ID 72661
510(K)Number K082421  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Merge Hemo with software versions 10.0 LA.

Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
Code Information Merge Hemo with software versions 10.0 LA
Recalling Firm/
Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact n/a
Manufacturer Reason
for Recall
The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
FDA Determined
Cause 2
Process control
Action Consignees were either contacted via phone 9/2015 or in person 7/31/2015. The customer communications involved the need to upgrade the consignees software. Merge Healthcare did not script the conversations because they opted to hold one-on-one management level discussions to carefully explain the importance of moving to the Generally Available (GA) release.
Quantity in Commerce 2
Distribution Distributed in the states of IL, NC, and VT.
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.