Fresenius Kabi USA is recalling 17 units of the Ivenix Infusion System (IIS) LVP Software, specifically version 5.9.1 and earlier. This software manages infusion pumps used to deliver medications and fluids to patients. The software contains defects that can cause the pump to stop functioning, trigger false alarms, or make the touchscreen unresponsive while therapy is actively being delivered. Consumers and healthcare providers should contact the manufacturer or their healthcare facility's technical department to verify if their system is affected and to receive the necessary software update.
The software anomalies can cause the pump to stop delivering life-sustaining medications or fluids without warning, or prevent clinicians from adjusting therapy through an unresponsive screen. These failures can lead to under-infusion or a complete interruption of treatment, which could result in serious patient harm or death.
Manufacturer initiated notification and software correction
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.
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Sources: FDA iRES · Raw API Response
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