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Recall Observatory FDA recall evidence

Device product

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

Z-1645-2023

March 06, 2023

Class II

Product summary

Firm
Philips North America Llc
Event
Event 92063
Status
Ongoing
Classification
Class II
Quantity
1421 units US; 3 units OUS
Official record key
device-enforcement:Z-1645-2023

Official wording

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.

Code information: UDI: (01)00884838091412 Software Version A.00.02 and A.00.01

Distribution pattern: Nationwide Foreign: Belgium Brazil Canada Denmark Germany Guam Hong Kong Indonesia Italy Norway Poland Singapore Sweden Switzerland United Kingdom

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.