Philips EarlyVue VS30 Vitals Monitor Recall: Software Issue Prevents Respiration Alarms
Philips recalls EarlyVue VS30 Vitals Monitors with specific serial numbers due to a software issue that may prevent alarms when respiration rates are outside safe limits. Affected units should be checked for serial numbers listed.
Use caution until it’s fixed
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Contact the company
What happened, in plain English
Philips is recalling EarlyVue VS30 Vitals Monitors that have a software problem which might stop the device from sounding alarms if breathing becomes too fast or too slow. This could lead to missing critical health changes and requires immediate attention. Read more at govinfonow.com/recall/57408-philips-earlyvue-vs30-vitals-monitor-recall-software-issue-prevents-respiration.
Source Summary by GovInfoNow · govinfonow.com/recall/57408-philips-earlyvue-vs30-vitals-monitor-recall-software-issue-prevents-respiration · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2654-2023
Cite this page
“Philips EarlyVue VS30 Vitals Monitor Recall: Software Issue Prevents Respiration Alarms.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57408-philips-earlyvue-vs30-vitals-monitor-recall-software-issue-prevents-respiration. Based on FDA recall #Z-2654-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2654-2023%22&limit=1).
Why it’s dangerous
The monitor's software fails to alert users when their breathing rate goes too high or too low. This could mean critical health changes go unnoticed, potentially leading to serious health issues if the device is used for monitoring.
Who’s affected
People using the EarlyVue VS30 Vitals Monitor for home health monitoring are affected. Those with breathing conditions or who rely on the device for critical health tracking are at higher risk.
How to tell if you have this one
Check the serial numbers on your EarlyVue VS30 Vitals Monitor. Affected units have serial numbers listed in the recall: DE72401360, DE72401393, DE72400231, DE72400232, DE72400235, DE72400254, DE72400237, DE72400238, DE72400239, DE72409250, DE72409240, DE72409249.
- Brand
Philips- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide - US Nationwide distribution in the states of MA, MI. The country of Brazil.
| Recall number | Product, codes & lots |
|---|---|
| Z-2654-2023 | EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380; UDI-DI: 00884838091412; Serial Numbers: DE72401360 DE72401393 DE72400231 DE72400232 DE72400235 DE72400254 DE72400237 DE72400238 DE72400239 DE72409250 DE72409240 DE72409249 |
| Z-2655-2023 | EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359; UDI-DI: 00884838075900; Serial Numbers: CN82203600 |
What to do — step by step
Check Serial Numbers
Look for the serial numbers listed in the recall: DE72401360, DE72401393, DE72400231, DE72400232, DE72400235, DE72400254, DE72400237, DE72400238, DE72400239, DE72409250, DE72409240, DE72409249.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
FDA distribution: “Worldwide - US Nationwide distribution in the states of MA, MI. The country of Brazil.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Massachusetts, Michigan.
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if my monitor has the listed serial numbers?
Check the serial numbers on your monitor. If it matches the list, contact Philips for further instructions.
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Where this comes from
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.
- Official source: FDA Recall #Z-2654-2023 (August 31, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2654-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.