Fresenius Kabi USA is recalling the LVP Software of the Ivenix Infusion System (IIS) version 5.8.0, affecting 17 units. The software contains anomalies that can cause the pump to deliver too much or too little medication, or cause a delay in starting life-sustaining therapy. While no specific injuries are reported in this data, these software issues could lead to serious patient harm or death. This system is used in healthcare settings to deliver fluids and medications to patients.
Software defects may cause the device to malfunction, resulting in a patient receiving an incorrect dose of medication or a critical delay in therapy, which can lead to life-threatening medical complications.
Manufacturer corrective action and professional guidance
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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