Device product

Merge Hemo, Software packages 10.2, 10.3, and 10.4

Z-2387-2021

July 23, 2021

Class II

Product summary

Firm: Merge Healthcare, Inc.
Event: Event 88379
Status: Terminated
Classification: Class II
Quantity: 326 units
Official record key: device-enforcement:Z-2387-2021

Official wording

Reason: 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.

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

Distribution pattern: US distribution

Derived failure modes

Device software or design
reason.device_software_design · v1.0.0

issue affecting the software