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Philips IntelliVue M3002A Recall Over Alarm Failure Affects 1,913,441 Units (2025)

Philips North America LLC recalled 1,913,441 IntelliVue Multi Measurement Server X2 M3002A monitors sold to hospitals and healthcare facilities worldwide after reports the devices could fail to alarm. The defect could delay critical warnings for patients. Healthcare facilities should stop using the devices immediately and follow recall instructions from Philips or their healthcare provider.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
October 31, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
October 31, 2025
Hazard Level
HIGH
Brand
Philips
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Philips
Product type
IntelliVue Multi Measurement Server M3002A (X2)
Model numbers
M3002A
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    October 31, 2025

  2. Reported by FDA DEVICE

    December 10, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Potential issue where the IntelliVue monitors did not alarm.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips North America Llc or your healthcare provider for instructions. Notification method: Letter

About This Product

The IntelliVue line includes patient monitoring systems used in hospitals to track vital signs and alarms. The M3002A is a Multi Measurement Server component used in front-end monitoring architectures.

Why This Is Dangerous

If the device fails to alarm, clinicians may not receive timely alerts about patient deterioration, increasing risk during care.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

Hospitals may face temporary workflow changes and the need to replace or repair affected units to maintain patient safety.

Practical Guidance

How to identify if yours is affected

  1. Check for Product Number M3002A on the device label.
  2. Review hospital procurement records for affected lots.

Where to find product info

Look at the device label near the power port or serial plate for M3002A and the UDI-DI code.

What timeline to expect

Remediation steps and refunds/replacements will be coordinated by Philips with affected facilities.

If the manufacturer is unresponsive

  • Escalate through hospital safety officers or biomedical engineering.
  • Document all communications with Philips and keep a copy of the recall notice.

How to prevent similar issues

  • Verify devices are within the supported recall list before deployment in patient care areas.
  • Ensure staff are trained to recognize unexpected alarm behavior and fallback procedures.

Documentation advice

Keep the recall notification, serial numbers, UDI codes, photos of labels, and all correspondence with Philips and hospital administration.

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Product Details

Product Number: M3002A Model: IntelliVue Multi Measurement Server X2 UDI-DI: 00884838000261 Sold at: Hospitals and healthcare facilities worldwide Distribution: Worldwide distribution including US nationwide and numerous countries Sold since: Unknown Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 1,913,441 units recalled worldwide
  • Product Number: M3002A; UDI-DI: 00884838000261
  • Recall Date: 2025-10-31; Status: ACTIVE; Hazard Level: HIGH
  • Hazard: Alarm failure in IntelliVue monitors
  • Remedy: Stop using immediately; follow Philips recall instructions; contact Philips North America L3
  • Distribution: Worldwide including US and dozens of countries

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTGENERAL
Injury Types
OTHER

Product Classification

Product Details

Brand
Model Numbers
M3002A
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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