The Recall Desk
HighFDA (Devices)·Z-1402-2025·Announced 2025-03-26

Merge Cardio Software Recalled: Measurement Inconsistency in Patient Reports

Merge Healthcare recalls Merge Cardio cardiovascular software due to measurement data inconsistency. When users manually edit or remeasure values in certain workflows, derived measurements may not match original measurements in patient reports.

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: This is an FDA Class II recall of medical device software involving a data accuracy issue. The source text does not report any illnesses, injuries, or hospitalizations. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, fitting the Score 3 (High) category.

Plain-English summary

Merge Healthcare, Inc. is recalling Merge Cardio, a software medical device that functions as an integrated multi-modality image cardiovascular information management system. This recall affects 253 units distributed in the United States, spanning multiple software versions from version 12.1 through 12.4.2.

The recall stems from a data accuracy issue that occurs during specific, less typical workflows. When users remeasure values using an ultrasound device or manually edit primitive or derived measurement values directly in the Clinical Reporting feature, the derived measurements may become inconsistent with the associated primitive measurements in the final patient report.

Users of Merge Cardio should be aware of this potential inconsistency, particularly if they perform manual measurement edits or remeasurement operations in the Clinical Reporting workflow. This data inconsistency could impact the accuracy of cardiovascular information displayed in patient reports.

The recalled product

Product
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system.
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Cardiovascular Imaging
Hazard
  • measurement-inconsistency
  • data-integrity

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 (12)

  • UDI: (01)00842000100928(10)12.1(11)210122
  • 12.1.1
  • UDI: (01)00842000100928(10)12.1.1(11)211220
  • 12.2 UDI: (01)00842000100065(10)12.2.0(11)220713
  • 12.3
  • UDI: (01)00842000101109(10)12.3.0(11)221114
  • 12.3.1 UDI: (01)00842000101109(10)12.3.0(11)221114
  • 12.3.2 UDI: (01)00842000101109(10)12.3.2(11)230612
  • 12.3.3 UDI: (01)00842000101109(10)12.3.3(11)230913
  • 12.4 UDI: (01)00842000101123(10)12.4.0(11)231220
  • 12.4.1 UDI: (01)00842000101123(10)12.4.1(11)240522
  • 12.4.2 UDI: (01)00842000101123(10)12.4.2(11)250206

Distribution

Distribution scope not specified by the agency.

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