Philips recalls EarlyVue VS30 Vitals monitors with software versions A.00.01 and A.00.02 due to missing calibration alarm that could cause inaccurate CO2 readings, potentially missing critical patient 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 Vitals monitors with specific software versions because they lack a calibration alarm, which might lead to inaccurate CO2 measurements. This could mean the device fails to detect serious patient changes, such as respiratory issues.
The monitor lacks a calibration alarm that should alert users when the device needs recalibration. Without this feature, CO2 measurements might become inaccurate, potentially missing critical changes in a patient's condition like breathing difficulties.
Patients using the EarlyVue VS30 Vitals monitor with software versions A.00.01 or A.00.02 are most at risk. This includes individuals with medical conditions requiring continuous monitoring.
Check for the product number 863380 on the monitor. The software version is either A.00.01 or A.00.02. These models were sold with specific software versions that lack the calibration alarm.
Look for the software version on the monitor's display or documentation to confirm it is A.00.01 or A.00.02.
The recall addresses a potential risk of inaccurate CO2 measurements, but it does not indicate immediate danger to users. The hazard is a possible failure to recognize patient changes, not an immediate risk of injury.
Check the product number 863380 and software version A.00.01 or A.00.02 on the monitor's display or documentation.
The recall does not specify a remedy, so users should check the software version and contact Philips for further guidance.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1645-2023 — Philips Philips Hello, I own a Philips that is covered by recall Z-1645-2023 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.
