HIGH

Philips Recalls IntelliVue MP20 Monitors Over Alarm Failure

Philips North America recalled 1,913,441 IntelliVue MP20 monitors on October 31, 2025. The monitors may fail to alarm, posing a high risk to patient safety. Healthcare providers and patients must 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 MP20, Product Number: M8001A. This monitor was distributed worldwide, including the U.S. and over 100 countries. The devices were sold at various healthcare facilities.

The Hazard

The IntelliVue MP20 monitors may not activate alarms as intended, which could lead to undetected medical emergencies. This recall falls under Class II, indicating a high risk to health.

Reported Incidents

There have been no specific injury reports related to this recall. The potential alarm failure could lead to serious health risks for patients.

What to Do

Stop using the IntelliVue MP20 monitors immediately. Follow the recall instructions provided by Philips North America and contact your healthcare provider for further guidance.

Contact Information

For assistance, contact Philips North America at their customer service line or visit their website for more information. More details can be found at the FDA recall page.

Key Facts

  • Recall date: October 31, 2025
  • Quantity recalled: 1,913,441 units
  • Global distribution including the U.S.
  • Potential alarm failure hazard

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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: M8001A
UDI-DI: 00884838000193
All Serial No.
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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