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Shenzhen Comen Medical Instruments Co., Ltd. · Model C50 · UDI-DI 06945429010046

DSJ MHX DSI MLD DRT DXN DQA CBQ DSK DPS CBR NHO DXG NHP DSB CCK CBS OLW FLL GXY CCL Prescription

510(k) clearances

121

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2023-08-31	Philips North America Llc	A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
2023-08-31	Philips North America Llc	A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
2023-03-06	Philips North America Llc	EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a cha
2023-03-06	Philips North America Llc	EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a cha

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.