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Recall Observatory FDA recall evidence

Derived label

Device software or design

ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software and a component failure
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
ResMed Ltd.

Field note

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