Merge Healthcare recalls VERICIS software versions 9.0.6 and 9.0.8 for potential inconsistent patient measurements when users remeasure ultrasound data or edit clinical reports. Affected units may need software updates to ensure accurate patient reports.
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 recalls specific software versions of their VERICIS cardiovascular system because inconsistent patient measurements can occur when users remeasure ultrasound data or edit clinical reports directly. This could lead to inaccurate patient reports if not corrected.
When users follow a specific workflow involving remeasuring ultrasound data or manually editing measurement values in clinical reports, derived measurements may not match the original measurements in the final patient report. This inconsistency could lead to inaccurate patient data being recorded.
Healthcare providers using VERICIS software versions 9.0.6 and 9.0.8 for cardiovascular imaging may be affected. Clinicians who manually edit measurements or remeasure ultrasound data in these versions are most at risk.
Check for VERICIS software versions 9.0.6 or 9.0.8, which have model catalog numbers 88-00061-00, 88-00062-00, 88-00063-00, or 88-00054-00. These versions were sold before the implementation of UDI (Unique Device Identification).
Verify your VERICIS software version by checking the model catalog numbers listed in the recall notice.
The recall is due to potential inconsistent patient measurements when users remeasure ultrasound data or manually edit clinical reports in specific workflows.
The recall notice does not specify a remedy, so you should check if your software version is affected and consider contacting Merge Healthcare for guidance.
The recall describes potential measurement inconsistencies but does not mention any risk of serious injury, so this is considered low risk.
We’ve drafted a message you can send Merge Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1398-2025 — Merge Healthcare Merge Healthcare Hello, I own a Merge Healthcare that is covered by recall Z-1398-2025 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.