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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:209801

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

Official recall number

Z-3153-2024

Evidence summary

Product code
FRN
Recall status
Open, Classified
Event initiated
August 30, 2024
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-3153-2024

Field note

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