Merge Healthcare, Inc.: VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The VERICIS is an integrated cardiovascular information syste

Hazard

When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.

Details from the source

Reason for recall: When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report. Distribution: US Quantity: 66 Lot/code info: Lot Code: Software Version Numbers and UDIs 11.0.2: UDI: (01)00842000100416(10)11.0.2.1523(11)180809; 11.0.3: UDI: (01)00842000100416(10)11.0.3.1601(11)181019; 11.0.4: UDI: (01)00842000100416(10)11.0.4(11)210207; 11.1: UDI: (01)00842000100751(10)11.1.0.1054(11)181211; 11.1.1: UDI: (01)00842000100751(10)11.1.1(11)190724

UPC codes

00842000100416, 00842000100751

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.