Merge Healthcare recalls specific software versions of their VERICIS Cardio system due to potential inconsistent measurements in patient reports when manually editing ultrasound data. Affected users should check their software version and contact support for updates.
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.
Merge Healthcare is recalling specific software versions of their VERICIS Cardio system because manual editing of ultrasound measurements can cause inconsistent patient reports. This could lead to incorrect medical decisions if not addressed.
The software can produce inconsistent measurements when users manually edit ultrasound data or remeasure values in clinical reports. This may result in patient reports showing conflicting measurements, potentially affecting medical decisions.
Healthcare providers using the VERICIS Cardio system with affected software versions are most at risk. Patients using the system may not be directly affected unless their care relies on inconsistent measurements.
Check your VERICIS Cardio software version (10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2, or 10.3) and part numbers listed in the recall notice. The system is used in hospitals and clinics for cardiovascular imaging.
Identify your VERICIS Cardio software version by checking the system settings or documentation.
Reach out to Merge Healthcare for guidance on updating to a safe software version.
The recall addresses a potential for inconsistent measurements in patient reports, but it does not pose an immediate risk of injury or harm. The hazard is technical and requires specific user actions to trigger.
Check your VERICIS Cardio software version against the list: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2, or 10.3. Also verify part numbers from the recall notice.
No, users can continue using the system but should update to a safe software version as recommended by Merge Healthcare.
We’ve drafted a message you can send Merge Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1399-2025 — Merge Healthcare Merge Healthcare Hello, I own a Merge Healthcare that is covered by recall Z-1399-2025 from Merge Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.