Exact FDA event identifier

Event 92063

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 06, 2023
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Philips North America Llc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-1644-2023

Recall number: Z-1644-2023
Initiated: March 06, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 64 units US; 20 units OUS

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI: (01)00884838075900 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

device · product 2 of 2

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

Z-1645-2023

Recall number: Z-1645-2023
Initiated: March 06, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 1421 units US; 3 units OUS

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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