{"url_path":"/fda/device/recalls/Z-2223-2026","section_key":"summary","section_title":"DEVICE Recall: Fresenius Kabi USA, LLC — LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-06","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2223-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Fresenius Kabi USA, LLC"},"word_count":117,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2223-2026\n\n**Recalling firm:** Fresenius Kabi USA, LLC\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-06\n**Report date:** 2026-06-10\n\n## Product\nLVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.\n\n## Reason\nPotential 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.\n\n## Affected lots\nProduct Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2\n\n## Distribution\nUS 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."}