CLASS II ONGOING Device recall · Reported 11 Oct 2023 · FDA Enforcement Report

EarlyVue VS30 Vital Signs Monitor, utilizing E01 recalled

Philips North America is recalling EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2), distributed nationwide in the US. The recall was initiated on 31 Aug 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00884838075900; Serial Numbers: CN82203600

Quantity recalled13 total devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2655-2023
FDA event ID: 93020
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 31 Aug 2023
FDA classified: 29 Sep 2023
Reported: 11 Oct 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

31 Aug 2023	Recall initiated by company
29 Sep 2023	Classified by FDA	+29 days
11 Oct 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Massachusetts Michigan

Questions about this recall

Why was it recalled?

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

Which lots are affected?

UDI-DI: 00884838075900; Serial Numbers: CN82203600

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 93020

This product is part of a recall event; the main page for the event is EarlyVue VS30 Vitals Monitor, utilizing E01 recalled.

Reported	Class	Recall	Company	Reason	Where
11 Oct 2023	CLASS II	EarlyVue VS30 Vitals Monitor, utilizing E01 recalled	Philips North America	Device Malfunction	Nationwide

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