Ivenix Infusion System software recalled for potential patient harm
Fresenius Kabi has recalled software version 5.10.1 and earlier for the Ivenix Infusion System due to anomalies that could cause serious patient harm. The affected software is used to control the delivery of fluids to patients in medical settings. About 30 units have been distributed across multiple U.S. states.
From the FDA notice · Read the official notice ↗ · All Fresenius Kabi recalls
What to do
- If your facility uses the Ivenix Infusion System, update to software version 5.10.2 or later immediately
- Do not use affected software version 5.10.1 or earlier for patient care
- Contact Fresenius Kabi for update instructions and technical support
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
- Sold in
- US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
- Made for
- All ages (under 100 years)
Details
- Units affected
- 30 units
- Illnesses reported
- None reported
- Manufactured in
- 50 High St Ste 50, North Andover, MA, United States
- Classification
- Class I
- Recall number
- Z-0885-2026
In the FDA's words
- Description
- Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients. Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death. Software Versions 5.10.1 and prior; UDI: 00811505030122. Distribution: US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI. Affected quantity: 30 units
- Hazard
- Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
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