Merge Healthcare, Inc. Merge Hemo, Software packages 10.2, 10.3, and 10.4 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Brand
Merge Healthcare, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Merge Healthcare, Inc. is recalling Merge Hemo, Software packages 10.2, 10.3, and 10.4 due to 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 interf. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026