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U.S. Department of Health and Human Services

Class 2 Device Recall Merge Hemo

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  Class 2 Device Recall Merge Hemo see related information
Date Initiated by Firm January 21, 2015
Date Posted August 06, 2015
Recall Status1 Terminated 3 on December 09, 2015
Recall Number Z-2347-2015
Recall Event ID 71814
510(K)Number K082421  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module. 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 9.10, 9.20.0, 9.20.1, 9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 are affected only if used with any Masimo PHASEIN EtCO2 module
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Merge Support
866-261-5761
Manufacturer Reason
for Recall		 A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, resulted in the user needing to move the patient to another cath lab.
FDA Determined
Cause 2		 Software design
Action Merge Healthcare sent an Important Product Information letter dated January 21, 2015, to all affected consignees. The letter described the Issue, Affected Product, Instructions, Product Updates, and Contact Information. For questions contact Merge Customer Service at (877) 741-5369 or support@merge.com A second UPDATE letter was sent April 16, 2015. The letter included the Product Updates. For questions regarding this recall call 866-261-5761.
Quantity in Commerce 451
Distribution Nationwide Distribution including IL, SC, WI, AL, CT, CA, LA, NM, TX, OK, GA, IA, OH, FL, CO, TN, NY, NC, MA, AR, MO, HI, ND, AK, UT, WV, WA, AZ, MI, PA, ME.
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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