FDA recall Z-2654-2023

Philips North America Llc · Class II · device

Product

EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-08-31
Report date
2023-10-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2654-2023