Merge Healthcare, Inc. has recalled approximately 369 units of its Merge Cardio cardiovascular software (versions 9.x through 12.x). The software can produce inconsistent patient measurements in clinical reports when a user remeasures with an ultrasound device or manually edits values within the reporting tool. No incidents or injuries have been reported to date.
Incorrect or inconsistent measurements in clinical reports could lead to diagnostic errors or inappropriate medical treatment plans for patients. This occurs when specific workflows fail to properly synchronize original measurements with edited or updated values.
Recall #: Z-1398-2025. Versions introduced prior to UDI implementation.
Recall #: Z-1399-2025.
Recall #: Z-1400-2025.
Recall #: Z-1401-2025.
Recall #: Z-1402-2025.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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