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

Reason: A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.

Code information: UDI-DI: 00884838075900; Serial Numbers: CN82203600

Distribution pattern: Worldwide - US Nationwide distribution in the states of MA, MI. The country of Brazil.