HomeMedical Device recalls
Medium severity

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

SourceFDA Device Enforcement
CategoryMedical Device
SeverityMedium
Statusongoing
Recall dateSeptember 03, 2025
ReportedNovember 05, 2025
Recalling firmFresenius Kabi USA, LLC
Country / regionUnited States MA

Hazard

Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.

Affected products

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