Z-2655-2023Class II

EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo...

Name: Z-2655-2023 EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo...
Creator: Philips North America Llc
Published: 2023-08-31
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-08-31 / Open, Classified / root cause: software

FDA source

Philips North America Llc began a recall of EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359 on 2023-08-31. FDA classified it as Class II and gives the reason as "A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2655-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-31
Posted: 2023-09-29
Recalling firm: Philips North America LLC
Product: EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
Product code: DSJ Alarm, Blood-Pressure
Reason for recall: A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 13 total devices
Distribution: Worldwide - US Nationwide distribution in the states of MA, MI. The country of Brazil.
Product codes and lots: UDI-DI: 00884838075900; Serial Numbers: CN82203600

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2655-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2654-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-09-29
Z-2655-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-09-29

Product code DSJ

K190624Class IIEarlyVue VS30Philips Medizin Systeme Boeblingen GmbH / cleared 2019-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)