CLASS II ONGOING Device recall · Reported 7 Jun 2023 · FDA Enforcement Report

EarlyVue VS30 Vitals monitor recalled by Philips North America

Philips North America is recalling EarlyVue VS30 Vitals monitor, distributed nationwide in the US. The recall was initiated on 6 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: (01)00884838091412 Software Version A.00.02 and A.00.01

Quantity recalled1421 units US; 3 units OUS

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-1645-2023
FDA event ID: 92063
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 6 Mar 2023
FDA classified: 26 May 2023
Reported: 7 Jun 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Patient Monitors

Timeline

6 Mar 2023	Recall initiated by company
26 May 2023	Classified by FDA	+81 days
7 Jun 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

EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition.

Product as listed by the FDA

EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380

Where it was distributed

Nationwide Foreign: Belgium Brazil Canada Denmark Germany Guam Hong Kong Indonesia Italy Norway Poland Singapore Sweden Switzerland United Kingdom

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI: (01)00884838091412 Software Version A.00.02 and A.00.01

Where was it sold?

Nationwide Foreign: Belgium Brazil Canada Denmark Germany Guam Hong Kong Indonesia Italy Norway Poland Singapore Sweden Switzerland United Kingdom

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 92063

This product is part of a recall event; the main page for the event is Earlyvue Vs30 Vital Signs Monitor recalled by Philips North America.

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023	CLASS II	Earlyvue Vs30 Vital Signs Monitor recalled by Philips North America	Philips North America	Labeling Errors	Nationwide

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