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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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.

The Hazard

The IntelliVue monitors can potentially fail to sound alarms, which may lead to undetected patient distress. This malfunction can significantly endanger patient safety in medical settings.

Reported Incidents

There have been no specific incidents or injuries reported related to this alarm failure. However, the potential risk remains classified as high due to the critical nature of patient monitoring.

What to Do

Immediately stop using the affected monitors. Contact Philips North America or your healthcare provider for detailed instructions on the recall and potential next steps.

Contact Information

For further assistance, contact Philips North America at their customer service number or visit their website for more information.

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.

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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
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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