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Philips North America Llc recalls EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) si
Recalled October 11, 2023 · FDA recall Z-2655-2023 · Philips North America
Hazard
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated. · FDA Class II
Units
13 total devices
Sold at
Worldwide - US Nationwide distribution in the states of MA, MI. The country of Brazil.
Description
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Product
EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
Manufacturer(s)
Philips North America Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →