LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
USLVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall / 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.
Product Description & Identification
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Additional Source Details
| Field | Value |
|---|---|
| City | North Andover |
| State | MA |
| Event id | 98929 |
| Address 1 | 50 High St Ste 50 |
| Code info | Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2 |
| Postal code | 01845-2620 |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 32 systems |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260506 |
| Initial firm notification | Letter |
| Center classification date | 20260603 |
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Overview
- Recalling FirmFresenius Kabi USA, LLC
- StatusOngoing
- Risk LevelClass I
- DistributionUS Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
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🚨 SAFETY ALERT: Fresenius Kabi USA, LLC - LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. Check if your household is affected: https://therecallfile.com/recalls/lvp-software-of-the-ivenix-infusion-system-iis-product-code-lvp-sw-000/FDA-Z-2223-2026
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