The Recall Desk
HighFDA (Devices)·Z-1398-2025·Announced 2025-03-26

VERICIS Merge Cardio Cardiovascular System Software Recall for Measurement Inconsistency

Merge Healthcare's VERICIS Merge Cardio software (versions 9.0.6 and 9.0.8) may produce measurement inconsistencies under specific workflows. Derived measurements may not match primitive measurements in final 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 a Class II medical device recall with no reported illnesses or injuries. However, the software defect can cause measurement inconsistencies in cardiac imaging that could potentially lead to diagnostic errors, qualifying it as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

VERICIS Merge Cardio (software versions 9.0.6 and 9.0.8) is a cardiovascular information system classified as a picture archiving and communications system (PACS), manufactured by Merge Healthcare, Inc. Two units have been distributed in the United States.

The software can generate measurement inconsistencies during specific, less typical workflows. When users remeasure data using the ultrasound device or manually edit primitive or derived measurement values in the Clinical Reporting module, derived measurements may become inconsistent with the associated primitive measurements, potentially resulting in inaccuracies in the final patient report.

Healthcare facilities using the affected VERICIS Merge Cardio software versions should contact Merge Healthcare, Inc. for guidance on this issue and any recommended corrective actions.

The recalled product

Product
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Medical Imaging Software
Hazard
  • measurement-inconsistency
  • diagnostic-error-risk

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 (6)

  • 9.0.8
  • Part Numbers: 88-00061-00
  • 88-00062-00
  • 88-00063-00
  • 88-00054-00
  • 88-00064-00

Distribution

Distribution scope not specified by the agency.

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