Z-1484-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2024
- Initiation Date
- March 7, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units
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.
Distribution Pattern
US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
Code Information
Product LVP-SW-0004; UDI-DI 00811505030122.