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GE Healthcare Finland Oy · Model Frame F5-01 · UDI-DI 00840682103992

DSJ BZQ MLD ORT MHX NHP DPZ OLW CBQ FLL DPS KOI NHQ DXG CBS GWJ NHO DQK CBR GWQ CCK DSK OLT CAP DQA CCL KRB BZL DRT OMC DSI DXN BZK Prescription

510(k) clearances

120

Adverse events

Recalls

Facilities

Description

FRAME F5-01

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.