Philips recalls EarlyVue VS30 Vital Signs Monitors with software versions A.00.01 and A.00.02 due to missing calibration alarm that could cause inaccurate CO2 readings, potentially missing patient health changes.
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.
Philips is recalling EarlyVue VS30 Vital Signs Monitors with specific software versions because they lack a calibration alarm. This could lead to inaccurate CO2 measurements, which might cause health issues if a patient's condition changes unexpectedly.
The monitor's missing calibration alarm means it can't alert users when measurements need recalibration. This could result in inaccurate CO2 readings, potentially missing critical changes in a patient's health condition.
Patients using the EarlyVue VS30 Vital Signs Monitor with software versions A.00.01 or A.00.02 are most at risk if they have a medical condition requiring precise CO2 monitoring.
Check for the product name 'EarlyVue VS30 Vital Signs Monitor' with software versions A.00.01 or A.00.02. The product number is 863359.
Look for the software version on the monitor's display or documentation to confirm it's A.00.01 or A.00.02.
The recall is for a potential risk of inaccurate CO2 measurements, but it does not cause immediate harm. The hazard is low risk as it requires specific conditions to affect patient health.
Check for the product name 'EarlyVue VS30 Vital Signs Monitor' with software versions A.00.01 or A.00.02. The product number is 863359.
The recall does not specify a remedy, so no action is required unless you notice inaccurate CO2 readings.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1644-2023 — Philips Philips Hello, I own a Philips that is covered by recall Z-1644-2023 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.