Philips North America Llc recalls EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microst
Recalled Product
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
Hazard / Issue
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00884838091412; Serial Numbers: DE72401360 DE72401393 DE72400231 DE72400232 DE72400235 DE72400254 DE72400237 DE72400238 DE72400239 DE72409250 DE72409240 DE72409249
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