FDA Medical Device Recalls (openFDA)
Philips North America Llc: EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
- Recall number
- Z-2655-2023
- 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
- Status
- Open, Classified
- Initiated
- 2023-08-31
- Posted
- 2023-09-29
- Terminated
- not on file
- Reason
- A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
- 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
- 13 total devices
- Distribution
- Worldwide - US Nationwide distribution in the states of MA, MI. The country of Brazil.
- Lot, serial or model codes
- UDI-DI: 00884838075900; Serial Numbers: CN82203600
- 510(k) numbers
- ["K190624"]
- PMA numbers
- not on file
- Product code
- DSJ
- Firm FEI
- 3016618143
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28