Merge Hemo, Software packages 10.2, 10.3, and 10.4
Check against the official notice below — it lists the full affected range.
Merge Healthcare, Inc. has recalled Merge Hemo software packages versions 10.2, 10.3, and 10.4 due to a safety issue identified in the software when used in combination with an HL7 lab interface. The recall affects 326 units distributed in the United States.
The source document does not specify what remedy is available to consumers or what steps affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US distribution Quantity: 326 units 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.