LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Reported: April 17, 2024 Initiated: March 7, 2024 #Z-1484-2024
Product Description
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Reason for Recall
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 17 units
- Distribution
- US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
- Location
- North Andover, MA
Frequently Asked Questions
What product was recalled? ▼
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.. Recalled by Fresenius Kabi USA, LLC. Units affected: 17 units.
Why was this product recalled? ▼
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 17, 2024. Severity: Critical. Recall number: Z-1484-2024.
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