Merge Healthcare is recalling 84 units of the Merge Hemo System (Model RCSV2) running software versions 11.1 and 11.1.1. The recall involves systems that include a specific Schiller ARGUS PB-3000 Patient Data Module which may trigger a "Pressure Sensor Defective" error message during blood pressure measurements. This error specifically occurs when the device is set to an initial inflation pressure above 240 mmHg.
The device may fail to provide blood pressure readings or provide an error message during high-pressure monitoring. This can lead to a loss of patient data or delays in treatment during critical cardiovascular procedures, potentially impacting clinical decisions.
Includes Schiller ARGUS PB-3000 Patient Data Module (PDM).
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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