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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 37
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.
Part of a larger recall action
This product is one of 5 recalled by Merge Healthcare, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Merge Healthcare, Inc.
See all →- HighMerge Healthcare Recalls PACS Workstations Due to Inaccurate Measurements
FDA (Devices) · 2026-09-02
- HighMerge PACS Medical Imaging Workstation Recalled Due to Patient Data Display Error
FDA (Devices) · 2026-08-12
- SevereMerge OrthoPACS Imaging Workstation Recall for Patient Data Display Issue
FDA (Devices) · 2026-08-12
- ModerateHemodynamic recording systems recalled over pressure sensor error during blood pressure measurement
FDA (Devices) · 2025-09-10
- HighVERICIS Merge Cardio Medical Device Software Measurement Data Consistency Issue
FDA (Devices) · 2025-03-26
Same hazard · measurement inconsistency
See all →- HighVERICIS Merge Cardio Cardiovascular System Software Recall for Measurement Inconsistency
FDA (Devices) · 2025-03-26
- HighVERICIS Merge Cardio may display inconsistent measurement data in clinical reports
FDA (Devices) · 2025-03-26
- HighMerge Cardio Software Recalled: Measurement Inconsistency in Patient Reports
FDA (Devices) · 2025-03-26
Similar recalls
- HighMerge Healthcare Software Recall for Inaccurate Z-Score Calculations
FDA (Devices) · 2020-07-01
- HighMerge Cardio software recalled for potential report matching errors
FDA (Devices) · 2016-12-21
- HighMerge Cardio software recalled for potential image loading errors
FDA (Devices) · 2017-01-25
- HighMerge Healthcare Recalls Merge Cardio Software Due to Data Integrity Issues
FDA (Devices) · 2017-03-29
- ModerateMerge Cardio software recalled for incorrect measurement units in reports
FDA (Devices) · 2017-03-15
- ModerateMerge Cardio software recall for missing patient information on report pages
FDA (Devices) · 2016-09-28