Philips North America Llc: EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380

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: 1421 units US; 3 units OUS Lot/code info: UDI: (01)00884838091412 Software Version A.00.02 and A.00.01

UPC codes

00884838091412

Source

Official record: FDA (Device enforcement) ↗

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