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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:203292

EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359

Official recall number

Z-2655-2023

Evidence summary

Product code
DSJ
Recall status
Open, Classified
Event initiated
August 31, 2023
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2655-2023

Field note

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