HIGH

Philips IntelliVue Monitor Recalled Due to Alarm Failure

Philips North America recalled 1,913,441 IntelliVue Multi Measurement Servers on October 31, 2025. These devices may fail to alarm, posing a serious risk to patient safety. Users 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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Product Details

The recalled product is the IntelliVue Multi Measurement Server X2, Product Number: M3002A. It has a UDI-DI of 00884838000261 and includes all serial numbers. The devices were distributed worldwide, including the United States.

The Hazard

The IntelliVue monitors have a potential issue that prevents alarms from sounding. This malfunction can lead to undetected patient emergencies. The recall has been classified as Class II by the FDA.

Reported Incidents

As of the recall date, no specific incidents or injuries have been reported. However, the lack of alarm functionality poses a high risk to patients.

What to Do

Stop using the IntelliVue Multi Measurement Server immediately. Contact Philips North America or your healthcare provider for further instructions. Follow the notification method provided in the recall letter.

Contact Information

For assistance, contact Philips North America LLC at their official website or through their customer service hotline.

Key Facts

  • Recall date: October 31, 2025
  • Total units recalled: 1,913,441
  • Potential hazard: Alarm failure
  • Classification: Class II
  • Distribution: Worldwide

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Safety Assessment

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

Product Classification

Product TypePatient Monitoring Device
Sold At
Multiple Retailers

Product Details

Model Numbers
Product Number: M3002A
UDI-DI: 00884838000261
All Serial No.
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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