Philips North America Llc: Medical Device Recall in 2023 - (Recall #: Z-1645-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 6, 2023

Date Posted: June 7, 2023

Recall Number: Z-1645-2023

Event ID: 92063

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.

Status: Ongoing

Product Quantity: 1421 units US; 3 units OUS

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

Voluntary or Mandated:

Voluntary: Firm initiated