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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:178314

Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

Official recall number

Z-0950-2020

Evidence summary

Product code
CBK
Recall status
Terminated
Event initiated
November 19, 2019
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0950-2020

Field note

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