# FDA recall Z-2655-2023

> **Philips North America Llc** · Class II · device recall initiated 2023-08-31.

## Product

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

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-2655-2023
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-31
- **Report date:** 2023-10-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2655-2023

## Citation

> AI Analytics. FDA recall Z-2655-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2655-2023. Source: US FDA. Licensed CC0.

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