Recall archive / FDA device enforcement
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated... — FDA record Z-1398-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 19, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
- Classification
- Class II
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 2
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1398-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | The following versions were introduced prior to the implementation of UDI. Version Numbers: 9.0.6, 9.0.8, Part Numbers: 88-00061-00, 88-00062-00, 88-00063-00, 88-00054-00, 88-00064-00, |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Mar 26, 2025
- Recall initiation date
- Feb 19, 2025
- Center classification date
- Mar 20, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.