Company: Philips North America Llc
Date of Enforcement Report: 09/29/2023
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Philips North America Llc
VOLUME OF PRODUCT IN COMMERCE:
13 total devices
Worldwide – US Nationwide distribution in the states of MA, MI. The country of Brazil.