Philips North America Llc: Medical Device Recall in 2023 - (Recall #: Z-2654-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 31, 2023

Date Posted: October 11, 2023

Recall Number: Z-2654-2023

Event ID: 93020

Reason for Recall:

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

Status: Ongoing

Product Quantity: 13 total devices

Code Information:

UDI-DI: 00884838091412; Serial Numbers: DE72401360 DE72401393 DE72400231 DE72400232 DE72400235 DE72400254 DE72400237 DE72400238 DE72400239 DE72409250 DE72409240 DE72409249

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated