FDAFDA · Food and drugs·Recall number Z-1398-2025
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.
Published March 26, 2025 · Recall initiated: February 19, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Merge Healthcare, Inc.
- Distributor
- US
- Lot
- 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,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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