EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultan

FDA device recall Z-2654-2023 · posted 2023-09-29 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

Reason for recall

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

Action taken

An URGENT Medical Device Correction notification letter dated 8/29/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users If you use EarlyVue VS30 devices with both options E01 (Oridion Microstream Sidestream etCO2) and option R21 (Masimo Rainbow RRa): 1) Observe the EarlyVue VS30 monitor display screen for out-of-limit acoustic respiration rates (RRa) during procedures when there is simultaneous use of E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa), while Respiration Source Mode is set to Auto, and the CO2 hardware module setting is switched to Standby. This notice should be passed on to all those who need to be aware within your organization or to any organization where EarlyVue VS30 with both options E01 (Oridion Microstream Sidestream etCO2) and option R21 (Masimo Rainbow RRa) devices have been transferred. Actions planned by Philips to correct the problem A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will perform software upgrade to your device. If you need any further information, please contact your local Philips representative, or call 1-800-722-9377.

Root cause

Software design

Status

Open, Classified

Product code

DSJ

Quantity affected

13 total devices

Distribution

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

Date initiated

2023-08-31

Date posted

2023-09-29

Location

Cambridge, MA

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