Company: Philips North America Llc
Date of Enforcement Report: 09/29/2023
Class II
PRODUCT
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
Recall Number:
Z-2654-2023
REASON:
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
RECALLING FIRM/MANUFACTURER:
Philips North America Llc
VOLUME OF PRODUCT IN COMMERCE:
13 total devices
DISTRIBUTION:
Worldwide – US Nationwide distribution in the states of MA, MI. The country of Brazil.
