Recall Z-1644-2023— Philips North America Llc

Name: FDA recall Z-1644-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-06

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2023-03-06. FDA's recall record names no specific 510(k) clearance for this event. Product: EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359. Reason: 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..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2023-03-06
Firm location: Cambridge, MA, United States

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.