# FDA recall Z-1645-2023

> **Philips North America Llc** · Class II · device recall initiated 2023-03-06.

## Product

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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1645-2023
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-06
- **Report date:** 2023-06-07

- **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-1645-2023

## Citation

> AI Analytics. FDA recall Z-1645-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1645-2023. Source: US FDA. Licensed CC0.

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