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Recall Observatory FDA recall evidence

Device product

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 picture archiving and communications system.

Z-1401-2025

February 19, 2025

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 96344
Status
Ongoing
Classification
Class II
Quantity
37
Official record key
device-enforcement:Z-1401-2025

Official wording

Reason: 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.

Code information: 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

Distribution pattern: US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.