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# FDA Early Alert on Fresenius Pump Software Updates
- URL: https://www.fdaweb.com/fda-early-alert-on-fresenius-pump-software-updates/
- Published: 2025-01-16T12:00:00.000Z
- Updated: 2026-09-14T14:51:07.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158504

FDA says it is aware that Fresenius Kabi USA has contacted affected healthcare providers recommending updates to certain software versions of the Ivenix Infusion System. An agency [Early Alert](https://www.fda.gov/medical-devices/medical-device-recalls/early-alert-infusion-pump-software-issue-fresenius-kabi-usa?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the recommended updates are related to a potentially high-risk device issue. The notice lists anomalies reported by the company associated with software version 5.9.2 and earlier. “These anomalies have the potential to cause serious patient harm or death,” the alert says.

Fresenius Kabi has not reported any injuries or deaths associated with the issue, FDA says.