Recall Z-2655-2023 ยท DSJ Alarm, Blood-Pressure
Philips North America Llc
EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
| Date | Sep 29, 2023 (initiated Aug 31, 2023) |
| Status | Open, Classified |
| 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, an |
| Quantity | 13 total devices |
| Distribution | Worldwide - US Nationwide distribution in the states of MA, MI. The country of Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190624 | EarlyVue VS30 Philips Medizin Systeme Boeblingen GmbH, Oct 27, 2019 |