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Recall Observatory FDA recall evidence

Derived label

Device software or design

Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
failure alarm condition. INOmax DSIR with software
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
INO Therapeutics (dba Ikaria)

Field note

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