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

Hazard

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

Details from the source

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. Quantity: 13 total devices Lot/code info: UDI-DI: 00884838091412; Serial Numbers: DE72401360 DE72401393 DE72400231 DE72400232 DE72400235 DE72400254 DE72400237 DE72400238 DE72400239 DE72409250 DE72409240 DE72409249

UPC codes

00884838091412

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.