Agency classClass IIOur severity:High FDA (Devices)·Z-1644-2023·Announced 2023-06-07

EarlyVue VS30 Vital Signs Monitor lacks calibration alarm, risking inaccurate CO2 readings

Philips EarlyVue VS30 vital signs monitors lack a calibration alarm, potentially causing inaccurate CO2 measurements. This could prevent clinicians from detecting changes in patient condition.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—a missing calibration alarm creates a risk of inaccurate CO2 measurement, which 'may lead to' failure to recognize patient condition changes. With no reported harms and a theoretical hazard, this fits the 'High' severity category for risk-of-harm medical devices.

Plain-English summary

Philips North America LLC is recalling EarlyVue VS30 Vital Signs Monitor units with software versions A.00.02 or A.00.01. The recall affects 64 units distributed in the United States and 20 units distributed internationally to Belgium, Brazil, Canada, Denmark, Germany, Guam, Hong Kong, Indonesia, Italy, Norway, Poland, Singapore, Sweden, Switzerland, and the United Kingdom.

The recalled monitors lack a calibration alarm function. Without this alarm, CO2 measurements may be inaccurate. Inaccurate CO2 measurements may lead to failure to recognize changes in a patient's condition.

Healthcare professionals and facility administrators using affected EarlyVue VS30 monitors with software versions A.00.02 or A.00.01 should be aware of this potential safety risk.

The recalled product

Product: EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Manufacturer: Philips North America Llc
Category: Medical Device — Vital Signs Monitor
Hazard: missing-alarm
inaccurate-measurement

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

UDI: (01)00884838075900 Software Version A.00.02 and A.00.01

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Philips North America Llc

See all →

High
Philips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
Moderate
Philips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
Moderate
Philips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
Moderate
Philips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Moderate
Philips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30

Same hazard · missing alarm