Merge Healthcare recalls VERICIS software versions 12.0.1 and 12.0.2 due to potential inconsistent measurements in patient reports when editing ultrasound data. Affected units may need updates to ensure accurate clinical reporting.
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 versions of their VERICIS software (12.0.1 and 12.0.2) because editing ultrasound measurements directly in reports can cause inconsistent patient data. This could lead to incorrect clinical decisions if not fixed.
The software may produce inconsistent measurements when users manually edit ultrasound data or remeasure values in clinical reports. This could lead to incorrect patient reports if not corrected.
Healthcare providers using the VERICIS software for cardiovascular imaging may be affected. Those who edit measurements directly in reports are most at risk of inaccurate patient data.
Check for software versions 12.0.1 or 12.0.2 on your VERICIS system. The lot codes include specific UDI numbers starting with (01)00842000100768.
Verify your VERICIS software version is 12.0.1 or 12.0.2 by checking the system settings.
The recall is due to potential inconsistent measurements in patient reports when users manually edit ultrasound data or remeasure values directly in clinical reports.
Check for software versions 12.0.1 or 12.0.2 on your VERICIS system. The lot codes include specific UDI numbers starting with (01)00842000100768.
The official notice does not specify a fix or remedy for this recall.
We’ve drafted a message you can send Merge Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1401-2025 — Merge Healthcare Merge Healthcare Hello, I own a Merge Healthcare that is covered by recall Z-1401-2025 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.
