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Recall Observatory FDA recall evidence

Derived label

Device software or design

LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
Software has anomalies
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Fresenius Kabi USA, LLC

Field note

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