Merge Healthcare recalls software versions 12.1-12.4.2 for potential inconsistent measurements in patient reports when remeasuring ultrasound data or editing values manually.
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 Merge Cardio system because measurements may become inconsistent when users remeasure ultrasound data or manually edit values in clinical reports. This could lead to inaccurate patient reports if not corrected.
When healthcare professionals remeasure ultrasound data or manually edit measurement values in clinical reports, the system may produce inconsistent results between primitive and derived measurements in the final patient report. This could lead to incorrect medical decisions if the measurements are not verified.
Healthcare providers using Merge Cardio software versions 12.1 through 12.4.2 are affected. Patients using these versions for cardiovascular imaging may be at risk of inaccurate measurements if the software is used incorrectly.
Check if your Merge Cardio software version is 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, or 12.4.1, 12.4.2. The software versions are identified by the version numbers listed in the recall notice.
Identify your Merge Cardio software version by checking the version numbers listed in the recall notice.
The recall indicates potential inconsistent measurements when remeasuring ultrasound data or editing values manually, but it does not state that the software causes injury or death.
Check if your software version is 12.1 through 12.4.2 as listed in the recall notice.
The recall does not specify a stop-use action; the remedy is null, so users can continue using the software but should be aware of potential measurement inconsistencies.
We’ve drafted a message you can send Merge Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1402-2025 — Merge Healthcare Merge Healthcare Hello, I own a Merge Healthcare that is covered by recall Z-1402-2025 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.
