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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 July 23, 2021
Create Date August 28, 2021
Recall Status1 Terminated 3 on August 29, 2023
Recall Number Z-2387-2021
Recall Event ID 88379
510(K)Number K152864  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Merge Hemo, Software packages 10.2, 10.3, and 10.4
Code Information Version 10.2, UDI (01)00842000100430(10)10.2(11)190612 Version 10.3, UDI (01)00842000100874(10)10.3(11)200330 Version 10.4, UDI (01)00842000100966(10)10.4(11)210428
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Mr. Todd Brill
627-528-1732
Manufacturer Reason
for Recall		 The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm issued an Urgent Field Safety Notice by email on 07/23/2021. The letter explained the issue and provided a workaround for the safe, continued use of the instrument until a software correction can be made.
Quantity in Commerce 326 units
Distribution US 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 = MERGE HEALTHCARE INCORPORATED
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