Merge Healthcare, Inc.: VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a pict

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: 37 Lot/code info: Lot Code: Software Version Numbers and UDIs 12.0.1, UDI: (01)00842000100768(10)12.0.1(11)200107; 12.0.2, UDI: (01)00842000100768(10)12.0.2(11)201117

UPC codes

00842000100768

Source

Official record: FDA (Device enforcement) ↗

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