Sep

2023

FDA Recall: Software Issue Prevents Monitor from Alarming

Company: Philips North America Llc
Date of Enforcement Report: 09/29/2023
Class II

PRODUCT

EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380

Recall Number:

Z-2654-2023

REASON:

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

RECALLING FIRM/MANUFACTURER:

Philips North America Llc

VOLUME OF PRODUCT IN COMMERCE:

13 total devices

DISTRIBUTION:

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

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Software Issue Prevents Monitor from Alarming

Allison Pate

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