HIGH

Philips Patient Monitor Recalled Over Alarm Malfunction

Philips North America recalled over 1.9 million IntelliVue Patient Monitors on October 31, 2025. The monitors may fail to sound alarms, posing a serious risk to patients. Healthcare providers must stop using these devices 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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Product Details

The IntelliVue Patient Monitor MX850, Product Number: 866470, is being recalled. The devices were distributed worldwide, including the United States and numerous countries across Europe, Asia, and Africa.

The Hazard

The recalled monitors may not alarm as intended. This malfunction could prevent timely medical interventions, posing a significant risk to patient safety.

Reported Incidents

There have been no specific incidents reported regarding injuries or deaths linked to this recall. The potential for serious consequences exists due to the failure of alarms.

What to Do

Stop using the IntelliVue Patient Monitor immediately. Contact Philips North America LLC or your healthcare provider for further instructions and follow the recall procedures provided.

Contact Information

For more information, visit the FDA recall page or contact Philips North America at their official website.

Key Facts

  • Recall date: October 31, 2025
  • Quantity recalled: 1,913,441 units
  • Potential alarm malfunction
  • Class II recall
  • Worldwide distribution

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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: 866470
UDI-DI: 00884838070790
All Serial No.
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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