EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
This recall is currently active, issued September 29, 2023. It was issued by Philips North America Llc.
- Company
- Philips North America Llc
- Recall Initiated
- August 31, 2023
- Posted
- September 29, 2023
- Recall Number
- Z-2654-2023
- Quantity
- 13 total devices
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
Reason for Recall
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Distribution
Worldwide - US Nationwide distribution in the states of MA, MI. The country of Brazil.
Lot / Code Info
UDI-DI: 00884838091412; Serial Numbers: DE72401360 DE72401393 DE72400231 DE72400232 DE72400235 DE72400254 DE72400237 DE72400238 DE72400239 DE72409250 DE72409240 DE72409249
Root Cause
Software design
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.