HIGH

Philips IntelliVue Patient Monitor MX800 Recalled for Alarm Failure

Philips North America recalled 1,913,441 IntelliVue Patient Monitors on October 31, 2025. The monitors may fail to alarm, posing a serious risk to patient safety. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

Quick Facts at a Glance

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

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

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About This Product

The IntelliVue Patient Monitor MX800 is a medical device used in healthcare facilities to continuously monitor patients' vital signs. Healthcare providers rely on its alarm system to alert them to potential changes in a patient's condition.

Why This Is Dangerous

The primary hazard is the failure of the monitor's alarm system, which may not alert healthcare providers in critical situations. This can lead to undetected deterioration of a patient's health status.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The lack of functioning alarms poses a serious risk to patient safety, particularly in emergency and intensive care settings, leading to potential undetected health issues.

Practical Guidance

How to identify if yours is affected

  1. Locate the product number on the monitor to confirm it is Product Number: 865240.
  2. Check the serial number against the recall list if available.
  3. If unsure, contact Philips customer service for verification.

Where to find product info

The product number and serial number are typically found on the back or bottom of the monitor.

What timeline to expect

Expect a refund or replacement processing time of approximately 4-6 weeks after returning the device.

If the manufacturer is unresponsive

  • Document all communication attempts with Philips.
  • Consider contacting the FDA for further assistance.
  • Keep records of the device's purchase and recall notice.

How to prevent similar issues

  • Always check for recalls on medical devices before use.
  • Ensure that medical devices are from reputable manufacturers with good safety records.
  • Regularly verify that devices have been maintained according to manufacturer guidelines.

Documentation advice

Keep copies of any correspondence with Philips, along with receipts and proof of purchase for your records.

Product Details

The IntelliVue Patient Monitor MX800, Product Number: 865240, is part of a global recall affecting 1,913,441 units. These monitors were distributed in the United States and numerous countries worldwide. They are used in healthcare settings to monitor patients' vital signs.

Key Facts

  • 1,913,441 units recalled
  • Failure to alarm may endanger patients
  • Distributors worldwide including the US
  • Immediate cessation of use advised
  • Affected model: IntelliVue Patient Monitor MX800

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
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Product Number: 865240
UDI-DI: 00884838020733
All Serial No.
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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