FDA Device recall Z-1399-2025
VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3
- FDA Device
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3 by Merge Healthcare, citing 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 Clin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1399-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-19 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Merge Healthcare |
| Distribution | n/a |
Product
VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The 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.
Identifiers
| code_info | Software Versions and Part Numbers: 10.0: Part Numbers: 88-00527-00, 88-00528-00, 88-00529-00, 88-00530-00, 88-0053…Software Versions and Part Numbers: 10.0: Part Numbers: 88-00527-00, 88-00528-00, 88-00529-00, 88-00530-00, 88-00531-00, 88-00532-00, 88-00533-00, 70-00008-00; 10.1.1.1: Part Numbers: 88-01094-00; 10.1.2: Part Numbers: 88-01074-00, 88-01075-00, 88-01076-00, 88-01077-00, 88-01078-00, 88-01079-00, 88-00781-00, 88-00803-00, 88-01080-00, 70-00473-00; 10.2.0: Part Numbers: 88-01115-00, 88-01116-00, 88-01117-00, 88-01118-00, 88-01119-00, 88-01120-00, 88-01121-00, 88-01122-00, 88-01123-00, 70-00491-00, 10.2 P2: Part Numbers: 88-01203-00 10.3 P1 UDI - (01)00842000100041(10)10.3.0.2009(11)170309 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-08-12 · Merge Healthcare - Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCS…
FDA Device · Class II · 2025-09-10 · Merge Healthcare - Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2
FDA Device · Class II · 2025-03-26 · Merge Healthcare
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1399-2025%22
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