Philips North America Llc: EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359

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.

Details from the source

Reason for recall: 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. Distribution: Nationwide Foreign: Belgium Brazil Canada Denmark Germany Guam Hong Kong Indonesia Italy Norway Poland Singapore Sweden Switzerland United Kingdom Quantity: 64 units US; 20 units OUS Lot/code info: UDI: (01)00884838075900 Software Version A.00.02 and A.00.01

UPC codes

00884838075900

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.