EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion… recallZ-2654-2023 · Philips North America Llc · initiated Aug 31, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
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Why it was recalled

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

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number: Z-2654-2023
Status: Open, Classified
Initiated by the company: Aug 31, 2023
Posted by the FDA: Sep 29, 2023
Recalling firm: Philips North America Llc
Quantity: 13 total devices
Product code: DSJ
FDA submissions: K190624
Distribution: Worldwide - US Nationwide distribution in the states of MA, MI. The country of Brazil.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 00884838091412; Serial Numbers: DE72401360 DE72401393 DE72400231 DE72400232 DE72400235 DE72400254 DE72400237 DE72400238 DE72400239 DE72409250 DE72409240 DE72409249

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

EarlyVue VS30 EarlyVue VS30 Vitals monitor
Philips Medizin Systeme Böblingen GmbH · Oximeter
2 recalls167 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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