FDA-Device2023-06-07Class II
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Philips North America Llc
Hazard
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 change in patient condition.
Sold states
Nationwide Foreign: Belgium Brazil Canada Denmark Germany Guam Hong Kong Indonesia Italy Norway Poland Singapore Sweden Switzerland United Kingdom
Affected count
64 units US; 20 units OUS
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1644-2023Don't want to check this manually?
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