FDA recall Z-1645-2023

Philips North America Llc · Class II · device

Product

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

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

Key facts

Status: Ongoing
Initiation date: 2023-03-06
Report date: 2023-06-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1645-2023