medical Class II Updated 2021-09-08

Merge Healthcare, Inc. recalls Merge Hemo, Software packages 10.2, 10.3, and 10.4

Recalled Product

Merge Hemo, Software packages 10.2, 10.3, and 10.4


Hazard / Issue

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.

Issued by

FDA

Distribution: US distribution
Lot/Code Info: 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
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