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Recall Observatory FDA recall evidence

Derived label

Device software or design

Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Draeger Medical, Inc.

Field note

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