Philips North America Llc recalls EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion M
Recalled Product
EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
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: 00884838075900; Serial Numbers: CN82203600
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