Home / Recalls / Philips North America Llc / Z-2655-2023

Z-2655-2023 Class II Ongoing

Recalled by Philips North America Llc — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
October 11, 2023
Initiation Date
August 31, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13 total devices

Product Description

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 Pattern

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

Code Information

UDI-DI: 00884838075900; Serial Numbers: CN82203600

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