Notice names this product. Fresenius Kabi USA’s LVP software of the Ivenix Infusion System (IIS) is named in FDA Class I recall Z-2223-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2. Units affected: 32 systems. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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 …
Company / brand: Fresenius Kabi USA
Affected product: LVP software of the Ivenix Infusion System (IIS)
Official ID Z-2223-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.