Fresenius Kabi USA, LLC
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A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →