Philips recalls EarlyVue VS30 Vital Signs Monitors with software issue preventing alarms for high/low acoustic respiration rate limits. Affected units may not alert during critical breathing events.
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Philips is recalling EarlyVue VS30 Vital Signs Monitors that have a software problem preventing alarms when breathing rates go outside safe limits. This could mean the monitor doesn't warn you if breathing becomes dangerously slow or fast, which is serious for medical monitoring.
The software issue means the monitor won't sound an alarm when the breathing rate goes too high or too low. This could prevent timely warnings during critical breathing events, potentially leading to medical emergencies if the patient's condition worsens.
Patients using this monitor for home medical monitoring are most at risk, particularly those with breathing conditions requiring close monitoring. Healthcare providers using the device for patient care may also be affected.
Check for the EarlyVue VS30 Vital Signs Monitor with Product Code 863359. Look for Serial Numbers starting with CN82203600. The device uses E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously.
Verify if the monitor has a software update available for the acoustic respiration rate alarm feature.
Reach out to Philips customer support for assistance with the software issue or potential remedies.
Yes, the recall applies to EarlyVue VS30 Vital Signs Monitors used for home medical monitoring.
Check for Product Code 863359 and Serial Numbers starting with CN82203600.
The recall record does not specify a fix, but Philips support may provide assistance.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2655-2023 — Philips Philips Hello, I own a Philips that is covered by recall Z-2655-2023 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.
