Ivenix pump software may report false battery health and shut down
The Ivenix Infusion System Large Volume Pump software is being recalled because a software anomaly can report a false battery-health value and trigger a shutdown alarm.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.
Plain-English summary
The LVP software of the Ivenix Infusion System, product code LVP-SW-0005, UDI-DI 00811505030122, software version 5.10.2, is being recalled. The action covers 32 systems.
The stated reason is a 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. The FDA classified the action as Class I, its most serious classification.
Distribution was nationwide in the United States, including California, Colorado, Florida, Georgia, Idaho, Illinois, Maryland and Michigan. The pumps are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected systems using the product code, UDI-DI and software version above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
- Manufacturer
- Fresenius Kabi USA, LLC
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2
Distribution
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