The Recall Desk
HighFDA (Devices)·Z-1400-2025·Announced 2025-03-26

VERICIS Merge Cardio Medical Device Software Measurement Data Consistency Issue

VERICIS Merge Cardio cardiovascular imaging software may display measurement values in patient reports that do not match original measurements when measurements are remeasured or manually edited. This affects 66 units distributed in the United States.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device affecting a risk-of-harm product used for cardiovascular diagnosis. Although the system could generate inaccurate patient reports, no injuries or illnesses have been reported. This meets the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Merge Healthcare, Inc. is recalling VERICIS Merge Cardio, an integrated cardiovascular information system used to generate reports of heart imaging measurements. Sixty-six units of the device distributed in the United States are affected, specifically those running software versions 11.0.2, 11.0.3, 11.0.4, 11.1, and 11.1.1.

Under certain conditions—specifically when users remeasure cardiac images using ultrasound devices or manually edit measurement values directly in the Clinical Reporting function—the final patient report may display measurement values that do not match the original measurements. The system may show derived measurements (calculated values) that are inconsistent with primitive measurements (original measured values).

This discrepancy could affect the accuracy of cardiac measurement reports generated by the affected software versions.

The recalled product

Product
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 system classified as a picture archiving and communications system.
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Cardiovascular Imaging System
Hazard
  • measurement-inconsistency
  • data-accuracy-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • 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

Distribution

Distribution scope not specified by the agency.

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