Agency classClass IIOur severity:High FDA (Devices)·Z-2655-2023·Announced 2023-10-11

Philips EarlyVue VS30 Monitor Software Flaw Disables Respiration Alarms

Philips is recalling the EarlyVue VS30 Vital Signs Monitor due to a software issue that prevents the device from alarming when a patient's respiration rate exceeds safe limits, potentially delaying critical clinical intervention.

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 a Class II FDA medical device recall involving failure of a critical monitoring and alarm function, with no reported hospitalizations or illnesses to date. The software defect creates a risk-of-harm by preventing clinically essential alarms, fitting the rubric criterion for high-severity risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips North America Llc is recalling the EarlyVue VS30 Vital Signs Monitor (Product Code 863359). The recall affects 13 devices distributed worldwide, with documented distribution in Massachusetts, Michigan, and Brazil.

A software defect in the monitor prevents it from alarming when the high or low acoustic respiration rate (RRa) limits are violated. This failure means clinical staff may not receive timely notification of dangerous changes in a patient's respiratory rate, potentially delaying life-saving interventions.

Healthcare facilities and providers using this device should contact Philips North America Llc immediately. The affected device serial number is CN82203600 (UDI-DI: 00884838075900). Facilities should cease use of the device and await instructions from the manufacturer regarding a software update or replacement.

The recalled product

Product: EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
Manufacturer: Philips North America Llc
Category: Medical Device — Vital Signs Monitor
Hazard: alarm-failure
respiratory-monitoring-defect
software-defect
Affected units: 13

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 (2)

UDI-DI: 00884838075900
Serial Numbers: CN82203600

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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

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