Cardiovascular Information System Measurement Inconsistency in Merge Cardio
Merge Healthcare's VERICIS Merge Cardio cardiovascular information system may display inconsistent measurements under specific workflows involving ultrasound remeasurement or manual measurement editing. No illnesses have been reported.
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 FDA device recall involving a risk-of-harm product where measurement inconsistencies in cardiovascular reporting could lead to clinical errors. No illnesses or injuries have been reported, placing it in the High severity category per the rubric.
Plain-English summary
The VERICIS Merge Cardio is an integrated cardiovascular information system used for archiving and analyzing cardiac imaging. 37 units were distributed in the United States.
Under specific, less typical workflows—particularly when users remeasure using ultrasound devices or manually edit measurement values directly in the Clinical Reporting module—the system may generate derived measurements that are inconsistent with the original primitive measurements in the final patient report.
No illnesses or injuries have been reported. Users of the affected software versions (12.0.1 and 12.0.2) who perform ultrasound remeasurements or manual measurement editing should contact Merge Healthcare for guidance.
The recalled product
- 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.
- Manufacturer
- Merge Healthcare, Inc.
- Hazard
- measurement-inconsistency
- clinical-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 (4)
- 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
Distribution scope not specified by the agency.
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