FDA recall Z-2655-2023

Philips North America Llc · Class II · device

Product

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

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-2655-2023