FDA-Device2023-10-11Class II
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
Philips North America Llc
Hazard
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Sold states
Worldwide - US Nationwide distribution in the states of MA, MI. The country of Brazil.
Affected count
13 total devices
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2654-2023Don't want to check this manually?
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