HIGH

Philips Recalls IntelliVue Patient Monitor Due to Alarm Failure

Philips North America recalled 1,913,441 IntelliVue Patient Monitors on October 31, 2025. The monitors may fail to alarm, posing serious risks to patients. Users must stop using the device immediately and follow the manufacturer's 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 is used in healthcare settings to monitor patients' vital signs. These monitors provide critical alerts for any changes in a patient's condition.

Why This Is Dangerous

The failure of the monitor to alarm poses a serious risk, as it may lead to undetected medical emergencies. This lack of signaling can prevent timely intervention by healthcare professionals.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects a significant number of devices, which may leave healthcare providers without reliable monitoring tools, thus posing a risk to patient safety.

Practical Guidance

How to identify if yours is affected

  1. Verify the product number on the device is 866064.
  2. Check for the UDI-DI code 00884838038776 on the packaging or device.
  3. Look for any recall notifications or letters from Philips.

Where to find product info

Product numbers and UDI codes are typically found on the back or bottom of the monitor.

What timeline to expect

Expect a refund or replacement processing time of approximately 4-8 weeks.

If the manufacturer is unresponsive

  • Document your communications with Philips.
  • Contact your healthcare provider for further advice.
  • Consider filing a complaint with the CPSC if unresponsive.

How to prevent similar issues

  • Ensure medical devices have reliable alarm systems before purchase.
  • Research current recalls and safety alerts for medical devices.
  • Choose manufacturers with a strong safety record.

Documentation advice

Keep records of all communications with Philips, including dates, times, and names of representatives.

Product Details

The recall involves IntelliVue Patient Monitor MX500, product number 866064. It was distributed worldwide, including the U.S. and several other countries. The monitors were sold through multiple retailers.

Key Facts

  • Class II recall affecting 1,913,441 units
  • Potential alarm failure hazard
  • Immediate stop-use instructions issued
  • Worldwide distribution including the U.S.

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: 866064
UDI-DI: 00884838038776
All Serial No.
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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