VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrate
FDA device recall Z-1401-2025 · posted 2025-03-20 · Open, Classified
Recall details
- Recalling firm
- Merge Healthcare, Inc.
- Reason for recall
- 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.
- Action taken
- Merge Healthcare issued an Urgent Field Safety Notice to it's consignees on 02/19/2025 via email. The notice explained the issue, risk to patients, provided a workaround to immediately address the issue, and recommended clinicians check measurements in the final report to ensure that they accurately reflect the patient's condition pending software update. Required Actions: Merge Healthcare Support will contact all customers to: i) Confirm that you have read and understood this Urgent Field Safety Notice. ii) Schedule an update to implement the configuration change on your system. For more information, please contact Merge Healthcare Support at 1-877-741-5369 (available 24 hours a day, 7 days a week) or visit our website: https://www.merative.com/support/merge. Please forward this notice to any individuals within your organization that may need to be aware of this notification. Customers should alert any other affiliated parties that may be affected by this Urgent Field Safety Notice. The firm identified a missing software version (11.0.2) and issued the corrected notice on 03/03/2025.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 37
- Distribution
- US
- Date initiated
- 2025-02-19
- Date posted
- 2025-03-20
- Location
- Hartland, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 (K051649) | Camtronics Medical Systems | 2005-08-02 |