FDA recall Z-3153-2024

Product

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.

Reason for recall

The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2024-08-30

Report date

2024-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3153-2024