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.
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 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.
- Affected units
- 2
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.
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
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