Recall Z-2654-2023— Philips North America Llc

Name: FDA recall Z-2654-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-31

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2023-08-31. It names one FDA 510(k) clearance: K190624. Product: EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380. Reason: A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2023-08-31
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K190624 — EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH·cleared 2019-10-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.